Advanced Gastric Carcinoma Clinical Trial
Official title:
Clinical Efficacy of Trastuzumab in Combination With Capecitabine and Oxaliplatin for the Treatment of HER2-positive Advanced Gastric Cancer: A Multicenter, Phase II Study
Verified date | August 2023 |
Source | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Trastuzumab plus chemotherapy prolonged the median overall survival in patients with human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer (AGC). Among chemotherapy regimens, oxaliplatin is generally more convenient and tolerable than cisplatin, and becoming an increasingly popular option for the treatment of AGC. The aim of the study was to evaluate the efficacy and safety of trastuzumab in combination with capecitabine and oxaliplatin (CAPOX) in HER2-positive AGC.
Status | Completed |
Enrollment | 60 |
Est. completion date | June 30, 2023 |
Est. primary completion date | February 28, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - HER2-positive AGC defined as either HER2 immunohistochemistry (IHC) 3+ or IHC 2+ and fluorescence in situ hybridization (FISH)+ with no history of previous treatment. Exclusion Criteria: - |
Country | Name | City | State |
---|---|---|---|
Bangladesh | Bangabandhu Sheikh Mujib Medical University | Dhaka |
Lead Sponsor | Collaborator |
---|---|
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh |
Bangladesh,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Loco-regional and Distant Tumor Control After Completion of Treatment | Response Evaluation Criteria in Solid Tumors was used to measure outcome:
Complete response (CR): Disappearance of all target lesions. Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions. Progressive disease (PD): At least a 20% increase in the sum of diameters of target lesions. Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. |
12 months | |
Secondary | Progression-free survival (PFS) | 28 months | ||
Secondary | Overall survival (OS) | 28 months |
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