Cisplatin and S-1 With or Without Nimotuzumab in Untreated Advanced Gastric Adenocarcinoma

Study Overview
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Brief Summary
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In this open-label, single-center, small sample size, randomised, parallel-group, controlled study, the investigators aim to assess efficacy and safety of addition of nimotuzumab to CS chemotherapy in patients with previously untreated advanced gastric adenocarcinoma. Sixty-two patients are required and randomly assigned (1:1) to each group. The control regimen (CS chemotherapy) is recommended as the standard first-line regimen for advanced adenocarcinoma of the stomach or gastroesophageal junction in japan.

Official Title
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Cisplatin and S-1 With or Without Nimotuzumab for Patients With Previously Untreated Advanced Gastric Adenocarcinoma: a Single-center, Randomised, Open-label, Parallel-group, Controlled Phase 2 Clinical Trial

Conditions
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Stomach Neoplasms

Intervention / Treatment
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* Drug: nimotuzumab
* Drug: cisplatin
* Drug: S-1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: provision of written informed consent; male or female; and aged ≥ 18 years; Histologically verified, untreated, metastatic or locally advanced inoperable adenocarcinoma or signet ring cell carcinoma of the stomach or gastroesophageal junction; At least one radiographically documented measurable lesion according to Response Evaluation Criteria In Solid Tumors Version 1.1(RECIST1.1) Criteria; An Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; and a life expectancy ≥ 3months; No previous palliative chemotherapy; Adequate function of vital organs: white blood cells (WBC) ≥ 4.0×109/L, neutrophils (ANA) ≥ 1.5 × 109/L, platelets ≥ 100 × 109/L, hemoglobin ≥ 90g/L (blood transfusion is permitted if necessary), serum bilirubin ≤ 1 times the upper normal limit (UNL), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times the UNL, alkaline phosphatase (AKP) ≤ 5 times the UNL, creatinine (Cr) ≤ 1 times the UNL, normal electrocardiography (ECG). Exclusion Criteria: pregnant or lactating patients, or reproductive women without effective contraception; Patients with only non-measurable disease: small lesions (longest diameter < 10mm or pathological lymph nodes with ≥ 10 to < 15mm short axis), Bone lesions, leptomeningeal disease, ascites, pleural or pericardial effusion, lymphangitic involvement of skin or lung; abdominal masses/abdominal organomegaly identified by physical exam that is not measurable by reproducible imaging techniques. Symptomatic of brain metastasis; Patients with clinically severe comorbidity including diabetes mellitus, hypertension, heart disease, or chronic active hepatitis (HBV carrier can be enrolled if circumstance permits ); No previous radiotherapy for measurable lesions.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NCS<br>nimotuzumab plus cisplatin and S-1 | Drug: nimotuzumab<br>* nimotuzumab 200mg infusion on day 1,8,15 every 3 weeks<br>Drug: cisplatin<br>* cisplatin: 30 mg/m2 iv. infusion on day 1, 2 every 3 weeks<br>Drug: S-1<br>* S-1: 40 mg/m2 bid , 2 weeks on, 1 week off ；<br>|
| Active Comparator: CS<br>cisplatin and S-1 | Drug: cisplatin<br>* cisplatin: 30 mg/m2 iv. infusion on day 1, 2 every 3 weeks<br>Drug: S-1<br>* S-1: 40 mg/m2 bid , 2 weeks on, 1 week off ；<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate as measured by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression as measured by RECIST 1.1 |  | 5 years | 
| Progression-free survival measured by RECIST 1.1 |  | 5 years | 
| Treatment safety and toxicity as measured by Common Toxicity Criteria for Adverse Effects(CTCAE 3.0) |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nimotuzumab, gastric adenocarcinoma, Cisplatin, S-1, epidermal growth factor receptor