Triplet Combination of Cytotoxics as First-line Treatment for Metastatic Gastric Cancer

Sun Yat-sen University

Status and phase: Enrolling; Phase 3

Conditions: Metastatic Gastric Cancer

Treatments: Drug: Oxaliplatin; Drug: Irinotecan; Drug: 5-fluorouracil

Study type: Interventional

Funder types: Other

Identifiers

NCT04358354

SAHMO206

Details and patient eligibility

About

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.

Full 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 cycles with RECIST. Toxicity will be assessed with WHO CTC 3.0 every 2 weeks.

Enrollment: 388 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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388 participants in 2 patient groups

FOLFOXiri group

Experimental 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.

Treatment:

Drug: 5-fluorouracil

Drug: Irinotecan

Drug: Oxaliplatin

FOLFOX group

Active Comparator 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.

Treatment:

Drug: 5-fluorouracil

Drug: Oxaliplatin