Stomach Neoplasms
Conditions
Keywords
nimotuzumab, gastric adenocarcinoma, Cisplatin, S-1, epidermal growth factor receptor
Brief summary
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.
Interventions
DRUGnimotuzumab
nimotuzumab 200mg infusion on day 1,8,15 every 3 weeks
DRUGcisplatin
cisplatin: 30 mg/m2 iv. infusion on day 1, 2 every 3 weeks
DRUGS-1
S-1: 40 mg/m2 bid , 2 weeks on, 1 week off ；
Sponsors
Chinese Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. provision of written informed consent; 2. male or female; and aged ≥ 18 years; 3. Histologically verified, untreated, metastatic or locally advanced inoperable adenocarcinoma or signet ring cell carcinoma of the stomach or gastroesophageal junction; 4. At least one radiographically documented measurable lesion according to Response Evaluation Criteria In Solid Tumors Version 1.1(RECIST1.1) Criteria; 5. An Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; and a life expectancy ≥ 3months; 6. No previous palliative chemotherapy; 7. 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
1. pregnant or lactating patients, or reproductive women without effective contraception; 2. 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. 3. Symptomatic of brain metastasis; 4. Patients with clinically severe comorbidity including diabetes mellitus, hypertension, heart disease, or chronic active hepatitis (HBV carrier can be enrolled if circumstance permits ); 5. No previous radiotherapy for measurable lesions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate as measured by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) | 5 years |
Secondary
| Measure | 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 |
Countries
China
Outcome results
None listed