EGFR Monoclonal Antibody for Advanced Gastric Cancer

Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04136600
• Other study ID #: EGFR-GC
• Status: Recruiting
• Phase: Phase 2
• Start date: July 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2020
• Source: Shanghai Changzheng Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Cetuximab
• Gastric Cancer
• Nimotuzumab
• Stomach Neoplasms

Intervention

Drug:
• EGFR antibody and Chemotherapy
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;
• Chemotherapy
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;

Locations

Country	Name	City	State
China	Department of Medical Oncology, Shanghai Changzheng Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Changzheng Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Overall Survival	Time from treatment beginning until death from any cause	From date of treatment beginning until the date of death from any cause through study completion, an average of 2 years
Secondary	Adverse Effect	Incidence of Treatment-related adverse Events	Incidence of Treatment-related adverse Events through study completion, an average of 2 years