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

Sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh (Other)

Overall Status

Completed

CT.gov ID

NCT05997524

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Gastric Carcinoma	Drug: Trastuzumab Drug: Oxaliplatin Drug: Capecitabine	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official 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

Actual Study Start Date :

Mar 1, 2021

Actual Primary Completion Date :

Feb 28, 2022

Actual Study Completion Date :

Jun 30, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Tras-Capox

Drug: Trastuzumab

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

Drug: Oxaliplatin

Oxaliplatin was administrated as a 130 mg/m2 infusion, q3w, for up to 6 cycles.

Drug: Capecitabine

Capecitabine 1000 mg/m2 was given orally twice daily on days 1-14 followed by a 7-day rest interval.

Outcome Measures

Primary Outcome Measures

Loco-regional and Distant Tumor Control After Completion of Treatment [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 Outcome Measures

Progression-free survival (PFS) [28 months]
Overall survival (OS) [28 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bangabandhu Sheikh Mujib Medical University	Dhaka		Bangladesh	1000

Sponsors and Collaborators

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Investigators

Study Chair: Sarwar Alam, MBBS, Mphil, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Ishtiaq-Ur-Rahim, Principal Investigator, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

ClinicalTrials.gov Identifier:

NCT05997524

Other Study ID Numbers:

SHL/2021/01

First Posted:

Aug 18, 2023

Last Update Posted:

Aug 18, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 18, 2023