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EGFR Monoclonal Antibody for Advanced Gastric Cancer

Primary Purpose

Gastric Cancer, Cetuximab, Nimotuzumab

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

EGFR antibody and Chemotherapy

Chemotherapy

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adult patients >=18 years of age
Inoperable locally advanced, recurrent, and/or metastatic cancer of the stomach or gastro-esophageal junction Adenocarcinoma
EGFR-Amplification tumors (Copy Number>=5 for tissue or blood Next Generation Sequence)
Expected survival ≥ 3 month;
ECOG / PS score: 0-2;
the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL <1.5 times the upper limit of normal (ULN); Liver ALT and AST <2.5 × ULN and if liver metastases, ALT and AST <5 × ULN; Serum Cr ≤ 1 × ULN, endogenous creatinine clearance ≥50ml/min;

Exclusion Criteria:

Previous chemotherapy for advanced/metastatic disease;
Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome;
History of cardiac disease;
Dyspnoea at rest, due to complications of advanced malignancy or other disease, or patients who require supportive oxygen therapy;
Patient can not comply with research program requirements or follow-up;

Sites / Locations

Department of Medical Oncology, Shanghai Changzheng HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

EGFR antibody arm

Placebo arm

Arm Description

Participants received a dose of 500 mg/m2 Cetuximab iv on Day 1 of cycle every 3 weeks, or 400mg Nimotuzumab on Day 1 of cycle, every week, until disease progression. 12 cycles of mFOLFOX (5-fluorouracil (5-FU) 1,200 mg/m2/day for 46 hours, leucovorin 200 mg/m2, and oxaliplatin 85 mg/m2 biweekly). 6-8 cycles of CapOX (Xeloda, 1000 mg/m2 po twice daily for 14 days every 3 weeks + oxaliplatin 135mg/m2 every 3 weeks). 6-8 cycles of SOX (S-1, 60mg for BSA>1.5, 50 mg for 1.5>BSA>1.25 , 40mg for BSA<1.25 po twice daily for 14 days every 3 weeks + oxaliplatin 135mg/m2 every 3 weeks)

12 cycles of mFOLFOX (5-fluorouracil (5-FU) 1,200 mg/m2/day for 46 hours, leucovorin 200 mg/m2, and oxaliplatin 85 mg/m2 biweekly). 6-8 cycles of CapOX (Xeloda, 1000 mg/m2 po twice daily for 14 days every 3 weeks + oxaliplatin 135mg/m2 every 3 weeks). 6-8 cycles of SOX (S-1, 60mg for BSA>1.5, 50 mg for 1.5>BSA>1.25 , 40mg for BSA<1.25 po twice daily for 14 days every 3 weeks + oxaliplatin 135mg/m2 every 3 weeks)

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS)

Time from treatment beginning until disease progression

Objective Response Rate

Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission.

Secondary Outcome Measures

Overall Survival

Time from treatment beginning until death from any cause

Adverse Effect

Incidence of Treatment-related adverse Events

Full Information

NCT ID

NCT04136600

First Posted

October 19, 2019

Last Updated

December 28, 2020

Sponsor

Shanghai Changzheng Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04136600

Brief Title

EGFR Monoclonal Antibody for Advanced Gastric Cancer

Official Title

A Study of EGFR Monoclonal Antibody (Cetuximab/Nimotuzumab) in Combination With Chemotherapy Compared With Chemotherapy Alone in Patients With EGFR-amplification Advanced Gastric Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Unknown status

Study Start Date

July 1, 2019 (Actual)

Primary Completion Date

August 31, 2021 (Anticipated)

Study Completion Date

December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Changzheng Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This study is intended to evaluate efficacy and safety of EGFR monoclonal antibody (Cetuximab/Nimotuzumab) in combination with a chemotherapy in gastric cancer patients with EGFR amplification.

Detailed Description

This parallel, randomized, open-label, single-centre study will evaluate the effect on overall survival of EGFR monoclonal antibody (Cetuximab/Nimotuzumab) in combination with a chemotherapy compared to the chemotherapy alone in patients with EGFR-amplication advanced gastric cancer. Cetuximab will be administered as intravenous infusion of 500 mg/m2 (BSA) every 3 weeks, while nimotuzumab will be administered as intravenous infusion of 400mg every week. The chemotherapy consists of a combination of 12 cycles of mFOLFOX-6, 6-8 cycles of SOX, 6-8 cycles of CapOX. Treatment with cetuximab/nimotuzumab will continue until disease progression. The target sample size is 50-100 patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer, Cetuximab, Nimotuzumab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

EGFR antibody arm

Arm Type

Experimental

Arm Description

Arm Title

Placebo arm

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

EGFR antibody and Chemotherapy

Intervention Description

Drug: Cetuximab Cetuximab: 500 mg/m2 iv on Day 1 of cycle every 3 weeks, until disease progression. Other Names: Erbitux Drug: Nimotuzumab Nimotuzumab: 400mg iv on Day 1 of cycle, every week, until disease progression Drug: Fluoropyrimidine 5-fluorouracil (5-FU): 2,400 mg/m2/day iv in first 46 hours of cycle, every two weeks for 12 cycles Other Names: 5-Fu Drug: Capecitabine Capecitabine: 1000 mg/m2 po twice daily for 14 days every 3 weeks, for 6 cycles Other Names: Xeloda Drug: S-1 S-1: 60mg for BSA>1.5, 50 mg for 1.5>BSA>1.25 , 40mg for BSA<1.25 po twice daily for 14 days every 3 weeks, for 6 cycles Other Names: S-1 Drug: Oxaliplatin Oxaliplatin: 85 mg/m2 iv on Day 1 of cycle, every 2 week for 12 cycles with 5-Fu; Oxaplatin: 130 mg/m2 iv on Day 1 of cycle, every 3 week for 6 cycles combined with S-1 or Capecitabine;

Intervention Type

Drug

Intervention Name(s)

Chemotherapy

Intervention Description

Drug: Fluoropyrimidine 5-fluorouracil (5-FU): 2,400 mg/m2/day iv in first 46 hours of cycle, every two weeks for 12 cycles Other Names: 5-Fu Drug: Capecitabine Capecitabine: 1000 mg/m2 po twice daily for 14 days every 3 weeks, for 6 cycles Other Names: Xeloda Drug: S-1 S-1: 60mg for BSA>1.5, 50 mg for 1.5>BSA>1.25 , 40mg for BSA<1.25 po twice daily for 14 days every 3 weeks, for 6 cycles Other Names: S-1 Drug: Oxaliplatin Oxaliplatin: 85 mg/m2 iv on Day 1 of cycle, every 2 week for 12 cycles with 5-Fu; Oxaplatin: 130 mg/m2 iv on Day 1 of cycle, every 3 week for 6 cycles combined with S-1 or Capecitabine;

Primary Outcome Measure Information:

Title

Progression-Free Survival (PFS)

Description

Time from treatment beginning until disease progression

Time Frame

Evaluation of tumor burden until first documented progress through study completion, an average of 2 years

Title

Objective Response Rate

Description

Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission.

Time Frame

Evaluation of tumor burden through study completion, an average of 2 years

Secondary Outcome Measure Information:

Title

Overall Survival

Description

Time from treatment beginning until death from any cause

Time Frame

From date of treatment beginning until the date of death from any cause through study completion, an average of 2 years

Title

Adverse Effect

Description

Incidence of Treatment-related adverse Events

Time Frame

Incidence of Treatment-related adverse Events through study completion, an average of 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult patients >=18 years of age Inoperable locally advanced, recurrent, and/or metastatic cancer of the stomach or gastro-esophageal junction Adenocarcinoma EGFR-Amplification tumors (Copy Number>=5 for tissue or blood Next Generation Sequence) Expected survival ≥ 3 month; ECOG / PS score: 0-2; the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL <1.5 times the upper limit of normal (ULN); Liver ALT and AST <2.5 × ULN and if liver metastases, ALT and AST <5 × ULN; Serum Cr ≤ 1 × ULN, endogenous creatinine clearance ≥50ml/min; Exclusion Criteria: Previous chemotherapy for advanced/metastatic disease; Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome; History of cardiac disease; Dyspnoea at rest, due to complications of advanced malignancy or other disease, or patients who require supportive oxygen therapy; Patient can not comply with research program requirements or follow-up;

Facility Information:

Facility Name

Department of Medical Oncology, Shanghai Changzheng Hospital

City

Shanghai

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiaodong Jiao

Phone

+86-13817797639

13817797639@139.com

First Name & Middle Initial & Last Name & Degree

Yuan-Sheng Zang

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

EGFR Monoclonal Antibody for Advanced Gastric Cancer

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