EGFR Monoclonal Antibody for Advanced Gastric Cancer

NCT04136600 | Unknown Phase 2

• 1 other identifier: EGFR-GC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer; Cetuximab; Nimotuzumab

Outcome Measures

Primary Outcomes (2)

• Progression-Free Survival (PFS)

  Time from treatment beginning until disease progression

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

• Objective Response Rate

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

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

Secondary Outcomes (2)

• Overall Survival

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

• Adverse Effect

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

Study Arms (2)

EGFR antibody arm

EXPERIMENTAL

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)

Drug: EGFR antibody and Chemotherapy

Placebo arm

PLACEBO COMPARATOR

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)

Drug: Chemotherapy

Interventions

EGFR antibody and Chemotherapy DRUG

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;

EGFR antibody arm

Chemotherapy DRUG

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;

Placebo arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Changzheng Hospital: lead

Study Sites (1)

Department of Medical Oncology, Shanghai Changzheng Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

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: Department Head

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: October 19, 2019
• First Posted: October 23, 2019
• Study Start: July 1, 2019
• Primary Completion: August 31, 2021
• Study Completion: December 31, 2021
• Last Updated: December 30, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)