Clinical trial · Interventional
Triplet Combination of Cytotoxics as First-line Treatment for Metastatic Gastric Cancer
Irinotecan Plus Oxaliplatin, 5-fluorouracil and Leucovorin as First-line Treatment for Metastatic Gastric Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 gastric cancer. Irinotecan will be administered as intravenous infusion of 150 mg/m2 every 2 weeks. Oxaliplatin will be given 85 mg/m2 and 5-FU will be given 400mg/m2 iv and 2400mg/m2 civ 48 hours fortnightly. Treatment will continue until disease progress or untolerable toxicity appears. The target sample size is 350-400 patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-fluorouracil | Drug | Fluorouracil | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- FOLFOXiri group
- description
- Irinotecan 150 mg/m2 iv drip d1; Oxaliplatin 85 mg/m2 iv drip d1; LV 200 mg/m2 iv drip d1; 5FU 400mg/m2 iv bolus and 2400 mg/m2 civ; The regimen will be repeated every 2 weeks until disease progression or untolerable toxicity.
- interventionNames
- Drug: Irinotecan
- Drug: Oxaliplatin
- Drug: 5-fluorouracil
- type
- ACTIVE_COMPARATOR
- label
- FOLFOX group
- description
- Oxaliplatin: 85 mg/m2 iv drip d1; LV 200 mg/m2 iv drip d1; 5FU 400mg/m2 iv bolus and 2400 mg/m2 civ 46h; The regimen will be repeated every 2 weeks until disease progression or untolerable toxicity.
- interventionNames
- Drug: Oxaliplatin
- Drug: 5-fluorouracil
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18-75 years old, gender is not limited; 2. Inoperable locally advanced, recurrent, and/or metastatic cancer of the stomach or gastro-esophageal junction; 3. Pathologically confirmed adenocarcinoma; 4. Expected survival time ≥ 3 months; 5. ECOG PS 0-3; 6. 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; 7. 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; 8. Be able to understand the research process, volunteer to participate in the study, and sign an informed consent form. Exclusion Criteria: 1. Patients known to be allergic to active or other components of chemotherapeutic drugs; 2. Patients with severe peritoneal dissemination and GI obstruction; 3. Her-2 overexprssion or d-MMR; 4. Severe or uncontrolled infections that may affect the evaluation of the study treatment or study results; 5. History of other malignant tumors in the past 5 years (except for cured cervical carcinoma in situ or basal cell carcinoma of the skin); 6. Participated in other clinical trials within 4 weeks prior to the start of the study; 7. Pregnant or lactating women, or women of childbearing age who refuse to take effective contraception during the study period.
References
Publications (0)
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