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

NCT ID: NCT02370849

Last Updated: 2015-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2015-02-28

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.

Conditions

Stomach Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NCS

nimotuzumab plus cisplatin and S-1

Group Type: EXPERIMENTAL

nimotuzumab

Intervention Type: DRUG

nimotuzumab 200mg infusion on day 1,8,15 every 3 weeks

cisplatin

Intervention Type: DRUG

cisplatin: 30 mg/m2 iv. infusion on day 1, 2 every 3 weeks

S-1

Intervention Type: DRUG

S-1: 40 mg/m2 bid , 2 weeks on, 1 week off ；

CS

cisplatin and S-1

Group Type: ACTIVE_COMPARATOR

cisplatin

Intervention Type: DRUG

cisplatin: 30 mg/m2 iv. infusion on day 1, 2 every 3 weeks

S-1

Intervention Type: DRUG

S-1: 40 mg/m2 bid , 2 weeks on, 1 week off ；

Interventions

nimotuzumab

nimotuzumab 200mg infusion on day 1,8,15 every 3 weeks

Intervention Type: DRUG

cisplatin

cisplatin: 30 mg/m2 iv. infusion on day 1, 2 every 3 weeks

Intervention Type: DRUG

S-1

S-1: 40 mg/m2 bid , 2 weeks on, 1 week off ；

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

yihebali chi

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yihebali Chi, Doctor

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, , China

Countries

China

Other Identifiers

20150207

Identifier Type: -

Identifier Source: org_study_id