Status:
UNKNOWN
Triplet Combination of Cytotoxics as First-line Treatment for Metastatic Gastric Cancer
Lead Sponsor:
Sixth Affiliated Hospital, Sun Yat-sen University
Conditions:
Metastatic Gastric Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This parallel, randomized, open-label study will evaluate the effect on overall survival of irinotecan on oxaliplatin and 5-fluorouracil (5-FU) in patients with HER2-negative and pMMR metastatic gastr...
Detailed Description
Eligible patients will be randomly assigned to FOLFOXiri group and FOLFOX group. Stratification factors include ECOG PS, disease extent and pathological subtypes. Efficacy will be evaluated every 3-4 ...
Eligibility Criteria
Inclusion
- Age 18-75 years old, gender is not limited;
- Inoperable locally advanced, recurrent, and/or metastatic cancer of the stomach or gastro-esophageal junction;
- Pathologically confirmed adenocarcinoma;
- Expected survival time ≥ 3 months;
- ECOG PS 0-3;
- Adequate bone marrow function reserve: white blood cell count ≥ 3.0 × 10\*9 / L, neutrophil count ≥ 1.5 × 10\*9/ L; platelet count ≥ 100 ×10\*9/ L; hemoglobin ≥ 90 g / L;
- AST and ALT ≤ 2.5 times the upper limit of normal value, total bilirubin ≤ 2 times the upper limit of normal value; serum creatinine ≤ 1.5 times the upper limit of normal value;
- Be able to understand the research process, volunteer to participate in the study, and sign an informed consent form.
Exclusion
- Patients known to be allergic to active or other components of chemotherapeutic drugs;
- Patients with severe peritoneal dissemination and GI obstruction;
- Her-2 overexprssion or d-MMR;
- Severe or uncontrolled infections that may affect the evaluation of the study treatment or study results;
- History of other malignant tumors in the past 5 years (except for cured cervical carcinoma in situ or basal cell carcinoma of the skin);
- Participated in other clinical trials within 4 weeks prior to the start of the study;
- Pregnant or lactating women, or women of childbearing age who refuse to take effective contraception during the study period.
Key Trial Info
Start Date :
October 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
388 Patients enrolled
Trial Details
Trial ID
NCT04358354
Start Date
October 22 2020
End Date
December 31 2024
Last Update
July 19 2021
Active Locations (1)
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1
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510655