Clinical Trials Directory

Trials / Completed

CompletedNCT05997524

Clinical Efficacy of Trastuzumab in Combination With Capecitabine and Oxaliplatin for the Treatment of HER2-positive Advanced Gastric Cancer.

Clinical Efficacy of Trastuzumab in Combination With Capecitabine and Oxaliplatin for the Treatment of HER2-positive Advanced Gastric Cancer: A Multicenter, Phase II Study

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGTrastuzumabTrastuzumab was administered at a loading dose of 8 mg/kg followed by 6 mg/kg infusion every 3 weeks (q3w).
DRUGOxaliplatinOxaliplatin was administrated as a 130 mg/m2 infusion, q3w, for up to 6 cycles.
DRUGCapecitabineCapecitabine 1000 mg/m2 was given orally twice daily on days 1-14 followed by a 7-day rest interval.

Timeline

Start date
2021-03-01
Primary completion
2022-02-28
Completion
2023-06-30
First posted
2023-08-18
Last updated
2023-08-18

Locations

1 site across 1 country: Bangladesh

Source: ClinicalTrials.gov record NCT05997524. Inclusion in this directory is not an endorsement.