NCT02370849

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2009

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 25, 2015

Completed
Last Updated

February 25, 2015

Status Verified

February 1, 2015

Enrollment Period

2.3 years

First QC Date

February 8, 2015

Last Update Submit

February 19, 2015

Conditions

Stomach Neoplasms

Keywords

nimotuzumabgastric adenocarcinomaCisplatinS-1epidermal growth factor receptor

Outcome Measures

Primary Outcomes (1)

  • Objective response rate as measured by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)

    5 years

Secondary Outcomes (3)

  • 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

Study Arms (2)

NCS

EXPERIMENTAL

nimotuzumab plus cisplatin and S-1

Drug: nimotuzumabDrug: cisplatinDrug: S-1

CS

ACTIVE COMPARATOR

cisplatin and S-1

Drug: cisplatinDrug: S-1

Interventions

nimotuzumabDRUG

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

NCS
cisplatinDRUG

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

CSNCS
S-1DRUG

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

CSNCS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, 100021, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

nimotuzumabCisplatinS 1 (combination)

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Yihebali Chi, Doctor

    Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 8, 2015

First Posted

February 25, 2015

Study Start

October 1, 2009

Primary Completion

February 1, 2012

Study Completion

February 1, 2015

Last Updated

February 25, 2015

Record last verified: 2015-02

Locations

CN(1)