RecruitingPhase 1Phase 2NCT05640830

Trastuzumab, Bevacizumab with Paclitaxel for HER2-positive Gastric Cancer in a Second-line Therapy

A Phase 1B/2 Study of Trastuzumab, Bevacizumab with Paclitaxel for HER2-positive Gastric Cancer in a Second-line Therapy (TREAZURE)


Sponsor

Kangbuk Samsung Hospital

Enrollment

47 participants

Start Date

Jan 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multicenter, open-label, prospective, phase 2 study of trastuzumab, bevacizumab, and paclitaxel as second-line treatment for patients with HER2-positive advanced gastric cancer who had progressed on first-line chemotherapy including trastuzumab or anti-HER2 agents.


Eligibility

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three drugs — trastuzumab (Herceptin), bevacizumab, and paclitaxel — as a second-line treatment for people with HER2-positive advanced stomach cancer whose cancer has progressed after initial therapy. **You may be eligible if...** - You have HER2-positive advanced gastric (stomach) cancer, confirmed by lab testing - Your cancer has gotten worse after one prior treatment for advanced disease - You are 19 years or older - Your overall health is good enough to receive treatment (ECOG 0, 1, or 2) - Your blood counts, liver, and kidney function are within acceptable ranges - You have measurable cancer lesions on imaging **You may NOT be eligible if...** - Your HER2 status is negative or unknown - You have not yet received any treatment for your advanced cancer - You have had more than one prior treatment line for advanced disease - Your organ function is too poor to tolerate the treatment - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGtrastuzumab, bevacizumab with paclitaxel (triple combination)

Trastuzumab 4 mg/kg Day 1, 15 Bevacizumab 5 mg/kg Day 1, 15 Paclitaxel 80 mg/m2 Day 1, 8, 15 every 4 weeks


Locations(1)

Kangbuk Samsung Hospital

Seoul, South Korea

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NCT05640830


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