A Phase 2 interventional study of Trastuzumab and Oxaliplatin in Advanced Gastric Carcinoma, sponsored by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh. Completed at 1 site in Bangladesh. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-18.
Sponsored by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh · Phase 2, Interventional, and Treatment
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.
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's enrollment of 60 is below the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh is the lead sponsor of 126 studies on the registry; 24 are open to participants now.
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Drug: Trastuzumab · Drug: Oxaliplatin · Drug: Capecitabine
Trastuzumab was administered at a loading dose of 8 mg/kg followed by 6 mg/kg infusion every 3 weeks (q3w).
Oxaliplatin was administrated as a 130 mg/m2 infusion, q3w, for up to 6 cycles.
Capecitabine 1000 mg/m2 was given orally twice daily on days 1-14 followed by a 7-day rest interval.
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.
Time frame: 12 months
Progression-free survival (PFS)
Time frame: 28 months
Overall survival (OS)
Time frame: 28 months
Plan to share: No
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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh