Cetuximab, Gastric Cancer, Nimotuzumab
Conditions
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.
Interventions
DRUGEGFR 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;
DRUGChemotherapy
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;
Sponsors
Shanghai Changzheng Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | Evaluation of tumor burden until first documented progress through study completion, an average of 2 years | Time from treatment beginning until disease progression |
| Objective Response Rate | Evaluation of tumor burden through study completion, an average of 2 years | Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | From date of treatment beginning until the date of death from any cause through study completion, an average of 2 years | Time from treatment beginning until death from any cause |
| Adverse Effect | Incidence of Treatment-related adverse Events through study completion, an average of 2 years | Incidence of Treatment-related adverse Events |
Countries
China
Outcome results
None listed