Clinical Efficacy of Trastuzumab in Combination With Capecitabine and Oxaliplatin for the Treatment of HER2-positive Advanced Gastric Cancer.
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Tras-Capox
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Drug: Trastuzumab
Trastuzumab was administered at a loading dose of 8 mg/kg followed by 6 mg/kg infusion every 3 weeks (q3w).
Drug: Oxaliplatin
Oxaliplatin was administrated as a 130 mg/m2 infusion, q3w, for up to 6 cycles.
Drug: Capecitabine
Capecitabine 1000 mg/m2 was given orally twice daily on days 1-14 followed by a 7-day rest interval.
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Outcome Measures
Primary Outcome Measures
- Loco-regional and Distant Tumor Control After Completion of Treatment [12 months]
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.
Secondary Outcome Measures
- Progression-free survival (PFS) [28 months]
- Overall survival (OS) [28 months]
Eligibility Criteria
Criteria
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:
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Bangabandhu Sheikh Mujib Medical University | Dhaka | Bangladesh | 1000 |
Sponsors and Collaborators
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Investigators
- Study Chair: Sarwar Alam, MBBS, Mphil, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SHL/2021/01