SBRT Plus Pembrolizumab and Trametinib for Pancreatic Cancer

• ClinicalTrials.gov Identifier: NCT02704156
• Recruitment Status: Completed
• First Posted: March 9, 2016
• Results First Posted: February 16, 2021
• Last Update Posted: May 13, 2022
• Sponsor: Changhai Hospital
• Information provided by (Responsible Party): Zhang Huo Jun, Changhai Hospital

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Pancreatic Cancer
• Interventions: Device: Cyberknife plus Pembrolizumab and Trametinib; Device: Cyberknife plus Gemcitabine
• Enrollment: 170

Participant Flow

Recruitment Details	Recruitment date was from October 2016 to October 2017. Patients were enrolled in our center.
Pre-assignment Details

Arm/Group Title	SBRT Plus Gemcitabine	SBRT Plus Pembrolizumab and Trametinib
Arm/Group Description	Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine. Cyberknife plus Gemcitabine: Radiation therapy plus drug	Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine. Cyberknife plus Pembrolizumab and Trametinib: Radiation therapy plus drug
Period Title: Overall Study
Started	85	85
Completed	85	85
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		SBRT Plus Gemcitabine	SBRT Plus Pembrolizumab and Trametinib	Total
Arm/Group Description		Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine. Cyberknife plus Gemcitabine: Radiation therapy plus drug	Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine. Cyberknife plus Pembrolizumab and Trametinib: Radiation therapy plus drug	Total of all reporting groups
Overall Number of Baseline Participants		85	85	170
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Median (Inter-Quartile Range); Unit of measure: Years
	Number Analyzed	85 participants	85 participants	170 participants
		66; (58 to 73)	65; (54 to 74)	65; (57 to 74)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	85 participants	85 participants	170 participants
	Female	33 38.8%	32 37.6%	65 38.2%
	Male	52 61.2%	53 62.4%	105 61.8%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	85 participants	85 participants	170 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	85 100.0%	85 100.0%	170 100.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	0 0.0%	0 0.0%	0 0.0%
	White	0 0.0%	0 0.0%	0 0.0%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
China	Number Analyzed	85 participants	85 participants	170 participants
		85	85	170
PD-L1 intensity [1]; Measure Type: Number; Unit of measure: Participants	Number Analyzed	85 participants	85 participants	170 participants
IC1 or TC1		56	60	116
IC2 or TC2		23	20	43
IC3 or TC3		6	5	11
		[1] Measure Description: PD-L1 tumor cell (TC) expression was scored as the percentage of PD-L1 TC, which was stratified as TC3 ≥ 50% or TC2 ≥ 5% but < 50% or TC1 ≥ 1% but <5%. PD-L1 tumor-infiltrating immune cells (IC) expression was scored as the percentage of tumor area stained positive, which was classified as IC3 ≥ 10% or IC2 ≥ 5% but < 10% or IC1 ≥ 1% but <5%. Briefly, the higher expression of TCor IC indicated worse outcomes.

Outcome Measures

1. Primary Outcome

Title	The Median Survival Time Will be Determined.
Description	The time from the start of treatment to death
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SBRT Plus Gemcitabine	SBRT Plus Pembrolizumab and Trametinib
Arm/Group Description:	Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine. Cyberknife plus Gemcitabine: Radiation therapy plus drug	Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine. Cyberknife plus Pembrolizumab and Trametinib: Radiation therapy plus drug
Overall Number of Participants Analyzed	85	85
Median (95% Confidence Interval); Unit of Measure: months
	12.8; (11.2 to 14.4)	14.9; (12.7 to 17.1)

2. Secondary Outcome

Title	One- and Two-year Overall Survival Rate Will be Determined.
Description	The number of patients alive at 1 year and 2 years.
Time Frame	2 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SBRT Plus Gemcitabine	SBRT Plus Pembrolizumab and Trametinib
Arm/Group Description:	Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine. Cyberknife plus Gemcitabine: Radiation therapy plus drug	Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine. Cyberknife plus Pembrolizumab and Trametinib: Radiation therapy plus drug
Overall Number of Participants Analyzed	85	85
Measure Type: Count of Participants; Unit of Measure: Participants
1-year OS rate	48 56.5%	53 62.4%
2-year OS rate	0 0.0%	2 2.4%

3. Secondary Outcome

Title	Treatment-related Adverse Effects Will be Determined.
Description	Treatment-related adverse effects are determined by National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SBRT Plus Gemcitabine	SBRT Plus Pembrolizumab and Trametinib
Arm/Group Description:	Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine. Cyberknife plus Gemcitabine: Radiation therapy plus drug	Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine. Cyberknife plus Pembrolizumab and Trametinib: Radiation therapy plus drug
Overall Number of Participants Analyzed	85	85
Measure Type: Count of Participants; Unit of Measure: Participants
Grade 3 pyrexia	0 0.0%	2 2.4%
Grade 3 vomitting	2 2.4%	1 1.2%
Grade 3 and 4 increased ALT or AST	6 7.1%	10 11.8%
Grade 3 stomatitis	0 0.0%	1 1.2%
Grade 3 rash	0 0.0%	2 2.4%
Grade 3 and 4 neutropenia	9 10.6%	1 1.2%
Grade 3 thrombocytopenia	4 4.7%	1 1.2%
Grade 3 increased blood bilirubin	0 0.0%	4 4.7%
Grade 3 hypokalemia	0 0.0%	1 1.2%
Grade 3 hyponatremia	0 0.0%	3 3.5%
Grade 3 pneumonia	0 0.0%	1 1.2%
Grade 3 hypertension	0 0.0%	2 2.4%

4. Secondary Outcome

Title	The Median Progression Free Survival Time Will be Determined.
Description	The time from the start of treatment until documentation of any clinical or radiological disease progression or death, whichever occurred first. Progression is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST; version 1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SBRT Plus Gemcitabine	SBRT Plus Pembrolizumab and Trametinib
Arm/Group Description:	Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine. Cyberknife plus Gemcitabine: Radiation therapy plus drug	Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine. Cyberknife plus Pembrolizumab and Trametinib: Radiation therapy plus drug
Overall Number of Participants Analyzed	85	85
Median (95% Confidence Interval); Unit of Measure: months
	5.4; (3.2 to 7.6)	8.2; (6.9 to 9.5)

5. Secondary Outcome

Title	One- and Two-year Progression Survival Rate Will be Determined. Will be Determined.
Description	The proportion of patients without disease progressions at 1 year and 2 years.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SBRT Plus Gemcitabine	SBRT Plus Pembrolizumab and Trametinib
Arm/Group Description:	Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine. Cyberknife plus Gemcitabine: Radiation therapy plus drug	Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine. Cyberknife plus Pembrolizumab and Trametinib: Radiation therapy plus drug
Overall Number of Participants Analyzed	85	85
Measure Type: Count of Participants; Unit of Measure: Participants
1-year PFS rate	7 8.2%	18 21.2%
2-year PFS rate	0 0.0%	0 0.0%

6. Secondary Outcome

Title	The Quality of Life Will be Analyzed.
Description	The analysis of quality of life is based on European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30). All scales and subscales range from 0 to 100. Regarding physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning and global health, higher scores may indicate better outcomes. In the case of fatigue, nausea and vomitting, pain, dyspnea, insomina, appetite loss, constipation, diarrhea and financial difficulties, lower scores may indicate better outcomes. Scales of all items are independent and not combined to compute a total score.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SBRT Plus Gemcitabine	SBRT Plus Pembrolizumab and Trametinib
Arm/Group Description:	Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine. Cyberknife plus Gemcitabine: Radiation therapy plus drug	Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine. Cyberknife plus Pembrolizumab and Trametinib: Radiation therapy plus drug
Overall Number of Participants Analyzed	85	85
Mean (Inter-Quartile Range); Unit of Measure: units on a scale
Physical functioning	86.2; (80 to 93.3)	83.7; (73.3 to 93.3)
Role functioning	81.8; (66.7 to 100)	84.5; (66.7 to 100)
Emotional functioning	73.9; (58.3 to 91.7)	72.1; (58.3 to 83.3)
Cognitive functioning	84.7; (66.7 to 100)	83.3; (66.7 to 100)
Social functioning	85.5; (83.3 to 100)	84.1; (66.7 to 100)
Global health	83.6; (75 to 91.7)	83.2; (75 to 91.7)
Fatigue	29.6; (10 to 43.3)	26.6; (10 to 43.3)
Nausea and vomitting	29.4; (16.7 to 50)	28.8; (0 to 50)
Pain	23.9; (0 to 50)	26.5; (16.7 to 50)
Dyspnea	16.1; (0 to 33.3)	13.7; (0 to 33.3)
Insomina	14.9; (0 to 33.3)	17.6; (0 to 33.3)
Appetite loss	31.0; (0 to 66.7)	33.3; (0 to 66.7)
Constipation	14.5; (0 to 33.3)	16.5; (0 to 33.3)
Diarrhea	15.7; (0 to 33.3)	15.7; (0 to 33.3)
Financial difficulties	16.8; (0 to 33.3)	17.2; (0 to 33.3)

Adverse Events

Time Frame	3 years
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	SBRT Plus Gemcitabine	SBRT Plus Pembrolizumab and Trametinib
Arm/Group Description	Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine. Cyberknife plus Gemcitabine: Radiation therapy plus drug	Patients with locally recurrent pancreatic cancer were randomly allocated to SBRT plus Pembrolizumab and Trametinib or SBRT plus Gemcitabine. Cyberknife plus Pembrolizumab and Trametinib: Radiation therapy plus drug
All-Cause Mortality
	SBRT Plus Gemcitabine	SBRT Plus Pembrolizumab and Trametinib
	Affected / at Risk (%)	Affected / at Risk (%)
Total	85/85 (100.00%)	83/85 (97.65%)
Serious Adverse Events
	SBRT Plus Gemcitabine	SBRT Plus Pembrolizumab and Trametinib
	Affected / at Risk (%)	Affected / at Risk (%)
Total	21/85 (24.71%)	29/85 (34.12%)
Blood and lymphatic system disorders
Grade 3 and 4 neutropenia †	9/85 (10.59%)	1/85 (1.18%)
Grade 3 thrombocytopenia †	4/85 (4.71%)	1/85 (1.18%)
Cardiac disorders
Grade 3 hypertension †	0/85 (0.00%)	2/85 (2.35%)
Gastrointestinal disorders
Grade 3 vomitting †	2/85 (2.35%)	1/85 (1.18%)
Grade 3 stomatitis †	0/85 (0.00%)	1/85 (1.18%)
General disorders
Grade 3 pyrexia †	0/85 (0.00%)	2/85 (2.35%)
Hepatobiliary disorders
Grade 3 and 4 increased ALT or AST †	6/85 (7.06%)	10/85 (11.76%)
Grade 3 increased blood bilirubin †	0/85 (0.00%)	4/85 (4.71%)
Metabolism and nutrition disorders
Grade 3 hypokalemia †	0/85 (0.00%)	1/85 (1.18%)
Grade 3 hyponatremia †	0/85 (0.00%)	3/85 (3.53%)
Respiratory, thoracic and mediastinal disorders
Grade 3 pneumonia †	0/85 (0.00%)	1/85 (1.18%)
Skin and subcutaneous tissue disorders
Grade 3 rash †	0/85 (0.00%)	2/85 (2.35%)
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	SBRT Plus Gemcitabine	SBRT Plus Pembrolizumab and Trametinib
	Affected / at Risk (%)	Affected / at Risk (%)
Total	85/85 (100.00%)	85/85 (100.00%)
Blood and lymphatic system disorders
Grade 1-2 neutropenia †	21/85 (24.71%)	6/85 (7.06%)
Grade 1-2 thrombocytopenia †	15/85 (17.65%)	7/85 (8.24%)
Gastrointestinal disorders
Grade 1-2 Nausea and vomitting †	17/85 (20.00%)	11/85 (12.94%)
Grade 1-2 diarrhea †	16/85 (18.82%)	18/85 (21.18%)
Grade 1-2 stomatitis †	0/85 (0.00%)	8/85 (9.41%)
Hepatobiliary disorders
Grade 1-2 increased ALT or AST †	12/85 (14.12%)	16/85 (18.82%)
Renal and urinary disorders
Grade 1-2 proteinuria †	2/85 (2.35%)	5/85 (5.88%)
Skin and subcutaneous tissue disorders
Grade 1-2 rash †	2/85 (2.35%)	14/85 (16.47%)
† Indicates events were collected by systematic assessment

Limitations and Caveats

The major limitation of the study was the small number of the randomized patients.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Huojun Zhang
• Organization: Changhai Hospital affiliated to Naval Medical University
• Phone: 86-021-31162207
• EMail: chyyzhj@163.com

Publications:

Siegel RL, Miller KD, Goding Sauer A, Fedewa SA, Butterly LF, Anderson JC, Cercek A, Smith RA, Jemal A. Colorectal cancer statistics, 2020. CA Cancer J Clin. 2020 May;70(3):145-164. doi: 10.3322/caac.21601. Epub 2020 Mar 5.

Oettle H, Neuhaus P, Hochhaus A, Hartmann JT, Gellert K, Ridwelski K, Niedergethmann M, Zulke C, Fahlke J, Arning MB, Sinn M, Hinke A, Riess H. Adjuvant chemotherapy with gemcitabine and long-term outcomes among patients with resected pancreatic cancer: the CONKO-001 randomized trial. JAMA. 2013 Oct 9;310(14):1473-81. doi: 10.1001/jama.2013.279201.

Dewan MZ, Galloway AE, Kawashima N, Dewyngaert JK, Babb JS, Formenti SC, Demaria S. Fractionated but not single-dose radiotherapy induces an immune-mediated abscopal effect when combined with anti-CTLA-4 antibody. Clin Cancer Res. 2009 Sep 1;15(17):5379-88. doi: 10.1158/1078-0432.CCR-09-0265. Epub 2009 Aug 25.

Verbrugge I, Hagekyriakou J, Sharp LL, Galli M, West A, McLaughlin NM, Duret H, Yagita H, Johnstone RW, Smyth MJ, Haynes NM. Radiotherapy increases the permissiveness of established mammary tumors to rejection by immunomodulatory antibodies. Cancer Res. 2012 Jul 1;72(13):3163-74. doi: 10.1158/0008-5472.CAN-12-0210. Epub 2012 May 8.

Royal RE, Levy C, Turner K, Mathur A, Hughes M, Kammula US, Sherry RM, Topalian SL, Yang JC, Lowy I, Rosenberg SA. Phase 2 trial of single agent Ipilimumab (anti-CTLA-4) for locally advanced or metastatic pancreatic adenocarcinoma. J Immunother. 2010 Oct;33(8):828-33. doi: 10.1097/CJI.0b013e3181eec14c.

Brahmer JR, Tykodi SS, Chow LQ, Hwu WJ, Topalian SL, Hwu P, Drake CG, Camacho LH, Kauh J, Odunsi K, Pitot HC, Hamid O, Bhatia S, Martins R, Eaton K, Chen S, Salay TM, Alaparthy S, Grosso JF, Korman AJ, Parker SM, Agrawal S, Goldberg SM, Pardoll DM, Gupta A, Wigginton JM. Safety and activity of anti-PD-L1 antibody in patients with advanced cancer. N Engl J Med. 2012 Jun 28;366(26):2455-65. doi: 10.1056/NEJMoa1200694. Epub 2012 Jun 2.

Chakraborty M, Abrams SI, Coleman CN, Camphausen K, Schlom J, Hodge JW. External beam radiation of tumors alters phenotype of tumor cells to render them susceptible to vaccine-mediated T-cell killing. Cancer Res. 2004 Jun 15;64(12):4328-37. doi: 10.1158/0008-5472.CAN-04-0073.

Bailey P, Chang DK, Nones K, Johns AL, Patch AM, Gingras MC, Miller DK, Christ AN, Bruxner TJ, Quinn MC, Nourse C, Murtaugh LC, Harliwong I, Idrisoglu S, Manning S, Nourbakhsh E, Wani S, Fink L, Holmes O, Chin V, Anderson MJ, Kazakoff S, Leonard C, Newell F, Waddell N, Wood S, Xu Q, Wilson PJ, Cloonan N, Kassahn KS, Taylor D, Quek K, Robertson A, Pantano L, Mincarelli L, Sanchez LN, Evers L, Wu J, Pinese M, Cowley MJ, Jones MD, Colvin EK, Nagrial AM, Humphrey ES, Chantrill LA, Mawson A, Humphris J, Chou A, Pajic M, Scarlett CJ, Pinho AV, Giry-Laterriere M, Rooman I, Samra JS, Kench JG, Lovell JA, Merrett ND, Toon CW, Epari K, Nguyen NQ, Barbour A, Zeps N, Moran-Jones K, Jamieson NB, Graham JS, Duthie F, Oien K, Hair J, Grutzmann R, Maitra A, Iacobuzio-Donahue CA, Wolfgang CL, Morgan RA, Lawlor RT, Corbo V, Bassi C, Rusev B, Capelli P, Salvia R, Tortora G, Mukhopadhyay D, Petersen GM; Australian Pancreatic Cancer Genome Initiative; Munzy DM, Fisher WE, Karim SA, Eshleman JR, Hruban RH, Pilarsky C, Morton JP, Sansom OJ, Scarpa A, Musgrove EA, Bailey UM, Hofmann O, Sutherland RL, Wheeler DA, Gill AJ, Gibbs RA, Pearson JV, Waddell N, Biankin AV, Grimmond SM. Genomic analyses identify molecular subtypes of pancreatic cancer. Nature. 2016 Mar 3;531(7592):47-52. doi: 10.1038/nature16965. Epub 2016 Feb 24.

McCormick F. KRAS as a Therapeutic Target. Clin Cancer Res. 2015 Apr 15;21(8):1797-801. doi: 10.1158/1078-0432.CCR-14-2662.

Eser S, Schnieke A, Schneider G, Saur D. Oncogenic KRAS signalling in pancreatic cancer. Br J Cancer. 2014 Aug 26;111(5):817-22. doi: 10.1038/bjc.2014.215. Epub 2014 Apr 22.

Vena F, Li Causi E, Rodriguez-Justo M, Goodstal S, Hagemann T, Hartley JA, Hochhauser D. The MEK1/2 Inhibitor Pimasertib Enhances Gemcitabine Efficacy in Pancreatic Cancer Models by Altering Ribonucleotide Reductase Subunit-1 (RRM1). Clin Cancer Res. 2015 Dec 15;21(24):5563-77. doi: 10.1158/1078-0432.CCR-15-0485. Epub 2015 Jul 30.

Kinsey CG, Camolotto SA, Boespflug AM, Guillen KP, Foth M, Truong A, Schuman SS, Shea JE, Seipp MT, Yap JT, Burrell LD, Lum DH, Whisenant JR, Gilcrease GW 3rd, Cavalieri CC, Rehbein KM, Cutler SL, Affolter KE, Welm AL, Welm BE, Scaife CL, Snyder EL, McMahon M. Protective autophagy elicited by RAF-->MEK-->ERK inhibition suggests a treatment strategy for RAS-driven cancers. Nat Med. 2019 Apr;25(4):620-627. doi: 10.1038/s41591-019-0367-9. Epub 2019 Mar 4. Erratum In: Nat Med. 2019 Mar 27;:

Bryant KL, Stalnecker CA, Zeitouni D, Klomp JE, Peng S, Tikunov AP, Gunda V, Pierobon M, Waters AM, George SD, Tomar G, Papke B, Hobbs GA, Yan L, Hayes TK, Diehl JN, Goode GD, Chaika NV, Wang Y, Zhang GF, Witkiewicz AK, Knudsen ES, Petricoin EF 3rd, Singh PK, Macdonald JM, Tran NL, Lyssiotis CA, Ying H, Kimmelman AC, Cox AD, Der CJ. Combination of ERK and autophagy inhibition as a treatment approach for pancreatic cancer. Nat Med. 2019 Apr;25(4):628-640. doi: 10.1038/s41591-019-0368-8. Epub 2019 Mar 4. Erratum In: Nat Med. 2020 Jun;26(6):982.

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

Zhu X, Cao Y, Liu W, Ju X, Zhao X, Jiang L, Ye Y, Jin G, Zhang H. Stereotactic body radiotherapy plus pembrolizumab and trametinib versus stereotactic body radiotherapy plus gemcitabine for locally recurrent pancreatic cancer after surgical resection: an open-label, randomised, controlled, phase 2 trial. Lancet Oncol. 2022 Mar;23(3):e105-e115. doi: 10.1016/S1470-2045(22)00066-3. Erratum In: Lancet Oncol. 2022 Mar;23(3):330.

Zhu X, Cao Y, Liu W, Ju X, Zhao X, Jiang L, Ye Y, Jin G, Zhang H. Stereotactic body radiotherapy plus pembrolizumab and trametinib versus stereotactic body radiotherapy plus gemcitabine for locally recurrent pancreatic cancer after surgical resection: an open-label, randomised, controlled, phase 2 trial. Lancet Oncol. 2021 Aug;22(8):1093-1102. doi: 10.1016/S1470-2045(21)00286-2. Epub 2021 Jul 5.

• Responsible Party: Zhang Huo Jun, Changhai Hospital
• ClinicalTrials.gov Identifier: NCT02704156
• Other Study ID Numbers: ChanghaiHosp
• First Submitted: March 1, 2016
• First Posted: March 9, 2016
• Results First Submitted: January 6, 2021
• Results First Posted: February 16, 2021
• Last Update Posted: May 13, 2022