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

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

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.

Study Overview

• Status: Completed
• Conditions: Stomach Neoplasms
• Intervention / Treatment: Drug: nimotuzumab; Drug: cisplatin; Drug: S-1

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100021
    • Cancer Hospital, Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: February 8, 2015
• First Submitted That Met QC Criteria: February 19, 2015
• First Posted (Estimate): February 25, 2015

Study Record Updates

• Last Update Posted (Estimate): February 25, 2015
• Last Update Submitted That Met QC Criteria: February 19, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Cisplatin; gastric adenocarcinoma; S-1; nimotuzumab; epidermal growth factor receptor
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Adenocarcinoma; Antineoplastic Agents; Antineoplastic Agents, Immunological; Nimotuzumab
• Other Study ID Numbers: 20150207