ToGA Study - A Study of Herceptin (Trastuzumab) in Combination With Chemotherapy Compared With Chemotherapy Alone in Patients With HER2-Positive Advanced Gastric Cancer

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ClinicalTrials.gov Identifier: NCT01041404

Recruitment Status : Completed

First Posted : December 31, 2009

Results First Posted : November 5, 2014

Last Update Posted : November 5, 2014

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Sponsor:

Collaborator:

Chugai Pharmaceutical

Information provided by (Responsible Party):

Hoffmann-La Roche

Study Description

Brief Summary:

This parallel, randomized, open-label, multi-centre study will evaluate the effect on overall survival of trastuzumab (Herceptin) in combination with a chemotherapy compared to the chemotherapy alone in patients with HER2-positive advanced gastric cancer. Trastuzumab (Herceptin) will be administered as intravenous infusion of 6 mg/kg (loading dose 8 mg/kg) every 3 weeks. The chemotherapy consists of a combination of 6 cycles of fluorouracil (800 mg/m2/day intravenous infusion every 3 weeks) and cisplatin (80 mg/m2 intravenous infusion every 3 weeks), or capecitabine (Xeloda, 1000 mg/m2 po twice daily for 14 days every 3 weeks) and cisplatin (80 mg/m2 intravenous infusion every 3 weeks). Treatment with trastuzumab (Herceptin) will continue until disease progression. The target sample size is 300-600 patients.

Condition or disease	Intervention/treatment	Phase
Gastric Cancer	Drug: Trastuzumab Drug: Fluorouracil Drug: Cisplatin Drug: Capecitabine	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	584 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Randomized, Open-label Study of the Effect of First-line Herceptin in Combination With a Fluoropyrimidine and Cisplatin Versus Chemotherapy Alone on Overall Survival in Patients With HER2-positive Advanced Gastric Cancer
Study Start Date :	September 2005
Actual Primary Completion Date :	June 2010
Actual Study Completion Date :	June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Drug Information available for: Cisplatin Trastuzumab

Genetic and Rare Diseases Information Center resources: Stomach Cancer

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Trastuzumab, Fluoropyrimidine, Cisplatin Participants received an initial loading dose of 8 milligrams per kilogram (mg/kg) trastuzumab i.v. on Day 1 of cycle, followed by 6 mg/kg i.v. every 3 weeks until disease progression; 800 mg/m2 fluorouracil i.v. on Days 1 through 5 of cycle every 3 weeks for 6 cycles; 80 mg/m2 cisplatin i.v. on Day 1 of cycle every 3 weeks for 6 cycles; and 1000 mg/m2 capecitabine p.o. twice daily on Days 1 through 15 of cycle every 3 weeks for 6 cycles.	Drug: Trastuzumab Initial loading dose 8 mg/kg i.v. infusion on Day 1 of cycle, followed by 6 mg/kg i.v. infusion every 3 weeks until disease progression Other Name: Herceptin Drug: Fluorouracil 800 mg/m2 i.v. infusion on Days 1 through 5 of cycle every 3 weeks for 6 cycles Other Name: 5-FU Drug: Cisplatin 80 mg/m2 i.v. infusion on Day 1 of cycle every 3 weeks for 6 cycles Drug: Capecitabine 1000 mg/m2 p.o. twice daily on Days 1 through 15 of cycle every 3 weeks for 6 cycles Other Name: Xeloda
Active Comparator: Fluoropyrimidine, Cisplatin Participants received 800 milligrams per square meter (mg/m2) fluorouracil intravenous (i.v.) on Days 1 through 5 of cycle every 3 weeks for 6 cycles; 80 mg/m2 cisplatin i.v. on Day 1 of cycle every 3 weeks for 6 cycles; and 1000 mg/m2 capecitabine orally (p.o.) twice daily on Days 1 through 15 of cycle every 3 weeks for 6 cycles.	Drug: Fluorouracil 800 mg/m2 i.v. infusion on Days 1 through 5 of cycle every 3 weeks for 6 cycles Other Name: 5-FU Drug: Cisplatin 80 mg/m2 i.v. infusion on Day 1 of cycle every 3 weeks for 6 cycles Drug: Capecitabine 1000 mg/m2 p.o. twice daily on Days 1 through 15 of cycle every 3 weeks for 6 cycles Other Name: Xeloda

Arm

Intervention/treatment

Experimental: Trastuzumab, Fluoropyrimidine, Cisplatin

Participants received an initial loading dose of 8 milligrams per kilogram (mg/kg) trastuzumab i.v. on Day 1 of cycle, followed by 6 mg/kg i.v. every 3 weeks until disease progression; 800 mg/m2 fluorouracil i.v. on Days 1 through 5 of cycle every 3 weeks for 6 cycles; 80 mg/m2 cisplatin i.v. on Day 1 of cycle every 3 weeks for 6 cycles; and 1000 mg/m2 capecitabine p.o. twice daily on Days 1 through 15 of cycle every 3 weeks for 6 cycles.

Drug: Trastuzumab

Initial loading dose 8 mg/kg i.v. infusion on Day 1 of cycle, followed by 6 mg/kg i.v. infusion every 3 weeks until disease progression

Other Name: Herceptin

Drug: Fluorouracil

800 mg/m2 i.v. infusion on Days 1 through 5 of cycle every 3 weeks for 6 cycles

Other Name: 5-FU

Drug: Cisplatin

80 mg/m2 i.v. infusion on Day 1 of cycle every 3 weeks for 6 cycles

Drug: Capecitabine

1000 mg/m2 p.o. twice daily on Days 1 through 15 of cycle every 3 weeks for 6 cycles

Other Name: Xeloda

Active Comparator: Fluoropyrimidine, Cisplatin

Participants received 800 milligrams per square meter (mg/m2) fluorouracil intravenous (i.v.) on Days 1 through 5 of cycle every 3 weeks for 6 cycles; 80 mg/m2 cisplatin i.v. on Day 1 of cycle every 3 weeks for 6 cycles; and 1000 mg/m2 capecitabine orally (p.o.) twice daily on Days 1 through 15 of cycle every 3 weeks for 6 cycles.

Drug: Fluorouracil

800 mg/m2 i.v. infusion on Days 1 through 5 of cycle every 3 weeks for 6 cycles

Other Name: 5-FU

Drug: Cisplatin

80 mg/m2 i.v. infusion on Day 1 of cycle every 3 weeks for 6 cycles

Drug: Capecitabine

1000 mg/m2 p.o. twice daily on Days 1 through 15 of cycle every 3 weeks for 6 cycles

Other Name: Xeloda

Outcome Measures

Primary Outcome Measures :

Overall Survival (OS) - Percentage of Participants With an Event [ Time Frame: Baseline (BL), Days 1, 8, 15, 22, 43, 64, 85, 106, 127, and every 21 days until the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis ]
OS was defined as the time from the date of randomization to the date of death due to any cause. Participants were censored at the last date of tumor measurement, the last date in the study drug log, or the date of last follow-up.
Overall Survival - Time to Event [ Time Frame: BL, Days 1, 8, 15, 22, 43, 64, 85, 106, 127, and every 21 days until the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis ]
The median time, in months, from the date of randomization to the date of an OS event. Participants were censored at the last date tumor measurement, the last date in the study drug log, or the date of last follow-up.

Secondary Outcome Measures :

Progression-Free Survival (PFS) - Percentage of Participants With an Event [ Time Frame: BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis ]
PFS was defined as the time from the date of randomization to the date of the first documentation of progressive disease (PD) or date of death, whichever occurs first. For target lesions (TL), PD was defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD) of TLs, taking as a reference the smallest SLD recorded since the treatment started, or the appearance of one or more lesions. For non-target lesions (NTL), PD was defined as an unequivocal progression of existing NTLs. Participants were censored at the last date of tumor measurement, the last date in the study drug log, or the date of last follow-up.
Progression-Free Survival - Time to Event [ Time Frame: BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis ]
The median time, in months, from the date of randomization to the date of a PFS event. Participants were censored at the last date of tumor measurement, the last date in the study drug log, or the date of last follow-up.
Time to Progression (TTP) - Percentage of Participants With an Event [ Time Frame: BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis ]
TTP was defined as the time from the date of randomization and the date of the first occurrence of PD. Participants were censored at the last date of tumor assessment, the last date in the study drug log, or the last date of follow-up.
Time to Progression - Time to Event [ Time Frame: BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis ]
The median time, in months, from the date of randomized to the date of a TTP event. Participants were censored at the last date of tumor assessment, the last date in the study drug log, or the last date of follow-up.
Percentage of Participants With Confirmed Complete Response (CR) or Partial Response (PR) Determined by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis ]
For TLs, a CR was defined as the disappearance of all TLs and a PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD. For NTLs, a CR was defined as the disappearance of all NTLs and normalization of tumor marker levels.
Duration of Response - Percentage of Participants With an Event [ Time Frame: BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis ]
Duration of response was defined for responders as the time from the date on which the CR or PR was first recorded to the date on which PD is first noted. Participants were censored on the date of death, the date of last tumor measurement, the last date in study drug log, or the date of last follow-up.
Duration of Response [ Time Frame: BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis ]
The median time, in months, of the duration of response. Participants were censored at the date of death, the date of last tumor measurement, the last date in study drug log, or the date of last follow-up.
Percentage of Participants With Clinical Benefit [ Time Frame: BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis ]
Clinical benefit was defined as stable disease (SD), CR, or PR for 6 weeks or longer as determined by RECIST. For TLs, SD was defined as neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD, taking as a reference the smallest SLD recorded since treatment had started. For NTLs, SD was defined as a persistence of one or more NTLs and/or maintenance of tumor marker levels above the normal limits.
European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores [ Time Frame: BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis ]
EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score equals (=) better level of functioning or greater degree of symptoms.
EORTC Quality of Life Questionnaire-Stomach Cancer Specific (QLQ STO22) Questionnaire Scores [ Time Frame: BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis ]
The QLQ-STO22 is a gastric cancer quality of life questionnaire. There are 22 questions concerning disease, treatment related symptoms, side effects, dysphagia, nutritional aspects, and questions about the emotional problems of gastric cancer (dysphagia, pain, reflux, eating restrictions, anxiety, dry mouth, body image, and hair loss). The questions are grouped into five scales and 4 single items which are related to the symptoms of the disease. Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 1 question was a yes or no answer). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100; higher score=better level of functioning or greater degree of symptoms.
Pain Intensity Scores as Assessed By Visual Analog Scale (VAS) [ Time Frame: BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis ]
The participant assessed their pain on a 0 to 100 millimeter (mm) horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as "no pain" and the right-hand extreme equals 100 mm as "unbearable pain". A negative change indicated improvement.
Percentage of Participants With a Change in Analgesic Medication During the Study [ Time Frame: BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis ]
Analgesic medications were recorded throughout the study until disease progression.
Body Weight (Kilograms [kg]) at BL [ Time Frame: BL ]
Percentage of Participants With Change From Baseline in Body Weight by Percentage Change in Weight [ Time Frame: BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis ]
Change in body weight was categorized as an increase of greater than (>)5 percent (%), no change (plus or minus [±]5%), decrease of >5-10%, or a decrease of >10% from BL to the end of study. Time windows were applied in order to assign visits to weight measurements, and the lowest post-screening value recorded was used for the analysis. The percentage change in weight from screening was summarized over time.
Steady State Trastuzumab Area Under the Concentration (AUC) [ Time Frame: Predose and end of infusion on Days 1, 8, 15, and 64, and predose on Days 22 and 106 ]
Individual steady state predicted exposure, as assessed by median AUC (measured as mg multiplied by [*] day per liter [L]) calculated for all treated participants using the nominal dosage schedule administered as an IV infusion. Individual steady state AUC was calculated using all available PK samples from all timepoints.
Trastuzumab Minimum Serum Concentration (Cmin) [ Time Frame: Predose and end of infusion on Days 1, 8, 15, and 64, and predose on Days 22 and 106 ]
Median Cmin (measured as milligrams per liter [mg/L]) calculated for all treated participants using the nominal dosage schedule administered as an IV infusion.
Trastuzumab Maximum Serum Concentration (Cmax) [ Time Frame: Predose and end of infusion on Days 1, 8, 15, and 64, and predose on Days 22 and 106 ]
Median Cmax (measured as mg/L) calculated for all treated participants using the nominal dosage schedule administered as an IV infusion.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adult patients >=18 years of age
Inoperable locally advanced, recurrent, and/or metastatic cancer of the stomach or gastro-esophageal junction
Adenocarcinoma
HER2-positive tumors

Exclusion Criteria:

Previous chemotherapy for advanced/metastatic disease
Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome
History of cardiac disease
Dyspnoea at rest, due to complications of advanced malignancy or other disease, or patients who require supportive oxygen therapy

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01041404

Locations

Show 142 study locations

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Australia

Adelaide, Australia, 5011

Kurralta Park, Australia, 5037

Melbourne, Australia, 3128

Milton, Australia, 4064

Perth, Australia, 6008

Sydney, Australia, 2217
Belgium

Leuven, Belgium, 3000
Brazil

Barretos, Brazil, 14784-400

Rio de Janeiro, Brazil, 20231-050

Sao Paulo, Brazil, 04023-900

Sao Paulo, Brazil, 05403-010
China

Beijing, China, 100021

Beijing, China, 100036

Beijing, China, 100071

Beijing, China, 100853

Guangdong, China, 510515

Guangzhou, China, 510060

Jiangsu, China, 210009

Nanjing, China, 210002

Shanghai, China, 200003

Shanghai, China, 200025

Shanghai, China, 200032

Shanghai, China, 200080

Shanghai, China, 200092

Shanghai, China, 200433

Suzhou, China, 215006

Wuhan, China, 430030
Costa Rica

San Jose, Costa Rica, 10103

San José, Costa Rica
Denmark

Herlev, Denmark, 2730

Odense, Denmark, 5000
Finland

Tampere, Finland, 33520
France

Brest, France, 29609

Caen, France, 14076

Colmar, France, 68024

Lille, France, 59020

Marseille, France, 13273

Reims, France, 51092

Rouen, France, 76031

Strasbourg, France, 67098
Germany

Heidelberg, Germany, 69120

Mainz, Germany, 55101

München, Germany, 81675

Trier, Germany, 54290

Witten, Germany, 58455
Guatemala

Guatemala City, Guatemala, 01015
India

Hyderabad, India, 500 033

Kochi, India, 682304

Mumbai, India, 400026

New Delhi, India, 110 029
Italy

Ancona, Italy, 60121

Firenze, Italy, 50139

Napoli, Italy, 80131

Parma, Italy, 43100

Roma, Italy, 00168

Udine, Italy, 33100
Japan

Aichi, Japan, 464-8681

Chiba, Japan, 277-8577

Ehime, Japan, 791-0280

Fukuoka, Japan, 812-8582

Hyogo, Japan, 650-0017

Nagano, Japan, 384-0392

Osaka, Japan, 569-8686

Osaka, Japan, 589-8511

Saitama, Japan, 350-1298

Saitama, Japan, 362-0806

Shizuoka, Japan, 411-8777

Tochigi, Japan, 320-0834

Tokyo, Japan, 113-8677

Tokyo, Japan, 135-8550

Tokyo, Japan, 135-8577

Yamagata, Japan, 990-8520
Korea, Republic of

Buchun, Korea, Republic of, 420-021

Bundang City, Korea, Republic of, 463-802

Daegu, Korea, Republic of, 702-210

Goyang-si, Korea, Republic of, 410-769

Pusan, Korea, Republic of, 602-715

Seoul, Korea, Republic of, 110-744

Seoul, Korea, Republic of, 120-752

Seoul, Korea, Republic of, 135-170

Seoul, Korea, Republic of, 135-720

Seoul, Korea, Republic of, 138-736

Seoul, Korea, Republic of
Mexico

Guadalajara, Mexico, 44280

Merida, Mexico, 97500

Mexico City, Mexico, 06760

Mexico City, Mexico, 14000

Monterrey, Mexico, 64020
Panama

Panama City, Panama
Peru

Callao, Peru

Lima, Peru, 11

Lima, Peru, 18
Portugal

Braga, Portugal, 4700

Coimbra, Portugal, 3000-075

Faro, Portugal, 8000

Guimaraes, Portugal, 4810-055

Lisboa, Portugal, 1099-023

Lisboa, Portugal, 1649-035

Porto, Portugal, 4099-001

Porto, Portugal, 4200-072

Porto, Portugal, 4200-319
Russian Federation

Chelyabinsk, Russian Federation, 454 087

Ekaterinburg, Russian Federation, 620905

Ivanovo, Russian Federation, 153040

Kazan, Russian Federation, 420029

Moscow, Russian Federation, 115478

Moscow, Russian Federation, 117837

Moscow, Russian Federation, 125284

Moscow, Russian Federation, 129128

Ryazan, Russian Federation, 390011

Samara, Russian Federation, 443031

St Petersburg, Russian Federation, 195067

St Petersburg, Russian Federation, 197022

St Petersburg, Russian Federation, 197758

UFA, Russian Federation, 450054

Yaroslavl, Russian Federation, 150054
South Africa

Cape Town, South Africa, 1925

Cape Town, South Africa, 7506

Durban, South Africa, 4091
Spain

Barcelona, Spain, 08036

Barcelona, Spain, 08041

Barcelona, Spain, 08907

Girona, Spain, 17007

Madrid, Spain, 28041

Valencia, Spain, 41014

Valencia, Spain, 46009
Taiwan

Changhua, Taiwan, 500

Kaohsiung, Taiwan, 807

Taipei, Taiwan, 00112
Turkey

Istanbul, Turkey, 34300

Istanbul, Turkey

Izmir, Turkey, 35100

Izmir, Turkey, 35340

Shhiye, Ankara, Turkey, 06100
United Kingdom

Birmingham, United Kingdom, B9 5SS

Denbigh, United Kingdom, LL18 5UJ

Dundee, United Kingdom, DD1 9SY

Glasgow, United Kingdom, G12 0YN

Manchester, United Kingdom, M2O 4BX

Weston Super Mare, United Kingdom, BS23 4TQ

Wirral, United Kingdom, CH63 4JY

Wolverhampton, United Kingdom, WV10 0QP

Sponsors and Collaborators

Hoffmann-La Roche

Chugai Pharmaceutical

Investigators

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Study Director:	Clinical Trials	Hoffmann-La Roche

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Van Cutsem E, Bang YJ, Feng-Yi F, Xu JM, Lee KW, Jiao SC, Chong JL, Lopez-Sanchez RI, Price T, Gladkov O, Stoss O, Hill J, Ng V, Lehle M, Thomas M, Kiermaier A, Ruschoff J. HER2 screening data from ToGA: targeting HER2 in gastric and gastroesophageal junction cancer. Gastric Cancer. 2015 Jul;18(3):476-84. doi: 10.1007/s10120-014-0402-y. Epub 2014 Jul 20.

Satoh T, Bang YJ, Gotovkin EA, Hamamoto Y, Kang YK, Moiseyenko VM, Ohtsu A, Van Cutsem E, Al-Sakaff N, Urspruch A, Hill J, Weber HA, Chung HC; ToGA Trial Investigators. Quality of life in the trastuzumab for gastric cancer trial. Oncologist. 2014 Jul;19(7):712-9. doi: 10.1634/theoncologist.2014-0058. Epub 2014 Jun 20.

Satoh T, Omuro Y, Sasaki Y, Hamamoto Y, Boku N, Tamura T, Ohtsu A. Pharmacokinetic analysis of capecitabine and cisplatin in combination with trastuzumab in Japanese patients with advanced HER2-positive gastric cancer. Cancer Chemother Pharmacol. 2012 Apr;69(4):949-55. doi: 10.1007/s00280-011-1783-9. Epub 2011 Nov 25.

Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, Lordick F, Ohtsu A, Omuro Y, Satoh T, Aprile G, Kulikov E, Hill J, Lehle M, Ruschoff J, Kang YK; ToGA Trial Investigators. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010 Aug 28;376(9742):687-97. doi: 10.1016/S0140-6736(10)61121-X. Epub 2010 Aug 19. Erratum In: Lancet. 2010 Oct 16;376(9749):1302.

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Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT01041404
Other Study ID Numbers:	BO18255
First Posted:	December 31, 2009 Key Record Dates
Results First Posted:	November 5, 2014
Last Update Posted:	November 5, 2014
Last Verified:	October 2014

Additional relevant MeSH terms:

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Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Capecitabine Fluorouracil	Trastuzumab Antineoplastic Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents, Immunological

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