Status:
UNKNOWN
EGFR Monoclonal Antibody for Advanced Gastric Cancer
Lead Sponsor:
Shanghai Changzheng Hospital
Conditions:
Gastric Cancer
Cetuximab
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04136600
Start Date
July 1 2019
End Date
December 31 2021
Last Update
December 30 2020
Active Locations (1)
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1
Department of Medical Oncology, Shanghai Changzheng Hospital
Shanghai, China