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

NCT ID: NCT05997524

Last Updated: 2023-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2023-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Advanced Gastric Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tras-Capox

Group Type EXPERIMENTAL

Trastuzumab

Intervention Type DRUG

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

Oxaliplatin

Intervention Type DRUG

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

Capecitabine

Intervention Type DRUG

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

Interventions

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Trastuzumab

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

Intervention Type DRUG

Oxaliplatin

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

Intervention Type DRUG

Capecitabine

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

Intervention Type DRUG

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

OTHER

Sponsor Role lead

Responsible Party

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Dr. Ishtiaq-Ur-Rahim

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sarwar Alam, MBBS, Mphil

Role: STUDY_CHAIR

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Locations

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Bangabandhu Sheikh Mujib Medical University

Dhaka, , Bangladesh

Site Status

Countries

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Bangladesh

Other Identifiers

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SHL/2021/01

Identifier Type: -

Identifier Source: org_study_id

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