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

Advanced Gastric Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05997524
• Other study ID #: SHL/2021/01
• Status: Completed
• Phase: Phase 2
• 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
• 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: -

Related Conditions & MeSH terms

• Advanced Gastric Carcinoma
• Stomach Neoplasms

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