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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05997524
Other study ID # SHL/2021/01
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date March 1, 2021
Est. completion date June 30, 2023

Study information

Verified date August 2023
Source Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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: -

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Bangladesh Bangabandhu Sheikh Mujib Medical University Dhaka

Sponsors (1)

Lead Sponsor Collaborator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

Outcome

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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