Skip to main content
OpenTrials
Completed

NCT Number: NCT05997524

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Advanced Gastric Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Bangabandhu Sheikh Mujib Medical University

Dhaka, 1000, Bangladesh

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Trastuzumab

Drug

Trastuzumab was administered at a loading dose of 8 mg/kg followed by 6 mg/kg infusion every 3 weeks (q3w).

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.

Primary outcomes

  1. Loco-regional and Distant Tumor Control After Completion of Treatment

    Time frame: 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 outcomes

  1. Progression-free survival (PFS)

    Time frame: 28 months

  2. Overall survival (OS)

    Time frame: 28 months

Sponsors and collaborators

Lead sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Aug 18, 2023
Registry last updated
Aug 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.