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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tras-Capox | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trastuzumab | Drug | Trastuzumab was administered at a loading dose of 8 mg/kg followed by 6 mg/kg infusion every 3 weeks (q3w). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | 28 months | |
| Overall survival (OS) | 28 months |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Sarwar Alam, MBBS, Mphil | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bangabandhu Sheikh Mujib Medical University | Dhaka | 1000 | Bangladesh |
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| Oxaliplatin | Drug | Oxaliplatin was administrated as a 130 mg/m2 infusion, q3w, for up to 6 cycles. |
|
| Capecitabine | Drug | Capecitabine 1000 mg/m2 was given orally twice daily on days 1-14 followed by a 7-day rest interval. |
|
| ID | Term |
|---|---|
| D000068878 | Trastuzumab |
| D000077150 | Oxaliplatin |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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