RecruitingPhase 1Phase 2NCT05927857

Ramucirumab (Cyramza), Nal-IRI (ONIVYDE) and Trifluridine/Tipiracil (Lonsurf) in Second Line Metastatic Gastric Cancer .

A Phase Ib/II Study of Ramucirumab (Cyramza®), Nal-IRI (ONIVYDE®) and Trifluridine/Tipiracil (Lonsurf®) in Second Line Metastatic Gastric Cancer (COOL Study).


Sponsor

National Health Research Institutes, Taiwan

Enrollment

45 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Primary Objectives * In phase 1b cohort, to determine MTD (maximum tolerated dose) of nal-IRI (ONIVYDE®) in combination with Ramucirumab (Cyramza®) and TAS-102 (LONSURF®) * In phase II cohort, to evaluate disease objective response rate (ORR) of Ramucirumab (Cyramza®), nal-IRI (ONIVYDE®) in combination with TAS-102 (LONSURF®) Secondary Objectives * To evaluate disease control rate (DCR) * To evaluate progression-free survival (PFS) * To evaluate overall survival (OS) * To assess the safety profile * To study the blood biomarkers


Eligibility

Min Age: 20 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests a three-drug combination — ramucirumab, nal-IRI, and trifluridine/tipiracil — as a second-line treatment for people with metastatic stomach cancer (or cancer of the stomach-esophagus junction) that has progressed after one prior treatment. **You may be eligible if...** - You are between 20 and 80 years old - You have confirmed metastatic stomach cancer or gastric junction cancer - Your cancer has progressed after only one prior line of chemotherapy - Your general health score (ECOG) is 0 or 1 - Your blood counts, kidney, and liver function meet the required levels - If your cancer is HER2-positive, you have previously received Herceptin (trastuzumab) **You may NOT be eligible if...** - You cannot swallow oral medications - You have a known allergy to irinotecan, fluoropyrimidine, or ramucirumab - You have had surgery in the past 4 weeks - You have significant diarrhea or fluid in the abdomen - You are pregnant or planning to become pregnant 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

DRUGnal-IRI /Experimental

infusional 50/60/70 mg/m2 over 90 minutes day 1, every 14 days.

DRUGRamucirumab /Experimental

infusional 8mg/kg over 60 minutes day 1, every 14 days.

DRUGTrifluridine/Tipiracil /Experimental

oral 30 mg/m2/b.i.d. day 1-5, every 14 days.


Locations(1)

Taipei Veterans General Hospital

Taipei, Taiwan/Taipei, Taiwan

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NCT05927857


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