Albumin-bound Paclitaxel Plus S-1 Versus SOX as First-line Treatment in Advanced or Recurrent Gastric Adenocarcinoma
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03801668 |
Recruitment Status : Unknown
Verified January 2022 by Xianglin Yuan, Huazhong University of Science and Technology.
Recruitment status was: Recruiting
First Posted : January 11, 2019
Last Update Posted : January 4, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gastric Cancer | Drug: Albumin-bound Paclitaxel plus S-1 Drug: Oxaliplatin plus S-1 | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 294 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multi-center, Open-label, Randomized Controlled Study of Albumin-bound Paclitaxel Plus S-1 Versus Oxaliplatin Plus S-1 (SOX) as First-line Treatment in Advanced or Recurrent Gastric Adenocarcinoma |
Actual Study Start Date : | March 8, 2019 |
Estimated Primary Completion Date : | December 31, 2022 |
Estimated Study Completion Date : | March 31, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: Nab-P/S-1
Patients in this arm receive chemotherapy with Albumin-bound Paclitaxel plus S-1.
|
Drug: Albumin-bound Paclitaxel plus S-1
Albumin-bound Paclitaxel 260mg/m2 IV on D1 plus S-1 80mg/m2 PO (Bid) on D1-14 every 21 days. |
Active Comparator: SOX
Patients in this arm receive chemotherapy with Oxaliplatin plus S-1.
|
Drug: Oxaliplatin plus S-1
Oxaliplatin 130mg/m2 IV on D1 plus S-1 80mg/m2 PO (Bid) on D1-14 every 21 days. |
- Progression-free Survival (PFS) [ Time Frame: up to 3 years ]PFS is defined as time from the start of treatment to progression of disease or death.
- Overall Response Rate (ORR) [ Time Frame: up to 3 years ]The rate of participants that achieve either a complete response (CR) or a partial response (PR).
- Overall survival (OS) [ Time Frame: up to 3 years ]Overall survival is defined as time from the start of treatment until death due to any reason.
- Safety as measured by number and grade of adverse events [ Time Frame: up to 3 years ]Summary adverse events according to NCI-CTCAE 4.03
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age of 18-75 years;
- Cytological or histological diagnosis of recurrent or metastatic gastric adenocarcinoma;
- At least one measurable lesion as defined by RECIST 1.1 criteria;
- ECOG performance status of 0-1;
- Estimated life expectancy of at least 3 months;
- Left ventricular ejection fraction (LVEF) ≥ 50%;
- Bone marrow function: absolute neutrophil count(ANC) ≥1.5×109 /L, platelet count(PLT) ≥90×109 /L, hemoglobin(HB) ≥90 g/L;
- Liver and kidney function: Creatinine(Cr)≤1.5 x upper limit of normal range(ULN); alanine glutamate transaminase (ALT) and glutamate transaminase (AST) ≤2.5 x upper limit of normal range (ULN), or ≤5 x upper limit of normal range (ULN)when with hepatic metastases,total bilirubin (TBIL)≤1.5 x upper limit of normal range (ULN), or≤2.5 x upper limit of normal range (ULN) when with Gilbert's syndrome;
- Not be breast-feeding; men and women of reproductive age are willing to take reliable contraceptive measures during the study;
- Able and willing to comply with the study plans in this protocol and sign the informed consent;
Exclusion Criteria:
- Have received chemotherapy before;patients that received neoadjuvant or adjuvant chemotherapy are eligible provided the treatment is completed>6 months prior to first recurrence or metastasis;
- HER-2 positive;
- Patients with symptomatic brain metastases;
- II-IV peripheral neuropathy [NCI-CTCAE 4.03];
- Anti-HCV antibody positive and HCV-RNA positive; anti-HBV antibody positive with active hepatitis ; anti-HIV antibody positive;
- Patients with serious systemic infection or other diseases;
- Allergic to the chemotherapy drugs or the materials in this study;
- Patients with gastrointestinal bleeding that need clinical intervention;
- Patients with digestive tract obstruction or oral nutrition difficulty;
- Have a second malignancy within 5 years prior to registration except for cured carcinoma in situ of cervix uteri, non-melanoma skin cancer;
- Have participated in other clinical trials within 28 days prior to the first dose of this study;
- Contraindications to chemotherapy;
- Patients that researcher consider cannot sign informed consent or complete the study plan due to medical science factor, social factor or psychological reasons.
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): NCT03801668
Contact: Xianglin Yuan, MD,PhD | 8627-83663406 | xlyuan1020@163.com | |
Contact: Hong Qiu, MD,PhD | 8627-83663406 | tjqiuhong@163.com |
China, Hubei | |
Tongji hospital of Tongji Medical College, Huazhong University of Science and Technology | Recruiting |
Wuhan, Hubei, China, 430030 | |
Contact: Xianglin Yuan, MD,PHD 8627-83663406 xlyuan1020@163.com | |
Contact: Hong Qiu, MD,PHD 8627-83663406 tjqiuhong@163.com | |
Principal Investigator: Xianglin Yuan, MD,PHD | |
Sub-Investigator: Hong Qiu, MD,PHD |
Study Chair: | Xianglin Yuan, MD,PhD | Tongji Hospital |
Responsible Party: | Xianglin Yuan, Professor, Head of the cancer center, Huazhong University of Science and Technology |
ClinicalTrials.gov Identifier: | NCT03801668 |
Other Study ID Numbers: |
TJCC008 |
First Posted: | January 11, 2019 Key Record Dates |
Last Update Posted: | January 4, 2022 |
Last Verified: | January 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Gastric Cancer Albumin-bound Paclitaxel |
Adenocarcinoma Stomach Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases |
Stomach Diseases Paclitaxel Oxaliplatin Albumin-Bound Paclitaxel Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |