Clinical trial NCT04136600: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Cancer
Cetuximab
Nimotuzumab
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
First posted: 2019-10-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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.

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;

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Evaluation of tumor burden until first documented progress through study completion, an average of 2 years
measure: Objective Response Rate
timeFrame: Evaluation of tumor burden through study completion, an average of 2 years
Secondary outcomes:
measure: Overall Survival
timeFrame: From date of treatment beginning until the date of death from any cause through study completion, an average of 2 years
measure: Adverse Effect
timeFrame: Incidence of Treatment-related adverse Events through study completion, an average of 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Medical Oncology, Shanghai Changzheng Hospital
Study officials:
References: