RecruitingPhase 3NCT06793917

Tislelizumab Plus FOLFOX Versus POF in the Treatment of Locally Advanced: a Multicenter, Open-label, Randomized Phase III Studyunresectable or Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma

Tislelizumab Plus FOLFOX Versus POF in the Treatment of Locally Advanced Unresectable or Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma


Sponsor

Fujian Cancer Hospital

Enrollment

269 participants

Start Date

Jun 7, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

To compare the efficacy and safety of tislelizumab combined with FOLFOX or combined with POF in the treatment of locally advanced unresectable or metastatic gastric/gastroesophageal junction adenocarcinoma with CPS≥1


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study compares two chemotherapy regimens — tislelizumab plus FOLFOX versus POF — in people with advanced stomach or stomach-esophagus junction cancer that cannot be surgically removed or has spread. Both regimens combine immunotherapy with chemotherapy. **You may be eligible if...** - You are 18–70 years old with confirmed advanced adenocarcinoma of the stomach or gastroesophageal junction - You have not received prior chemotherapy, radiation, or immunotherapy for this cancer - Your blood counts and organ function are adequate - Your expected survival is at least 3 months **You may NOT be eligible if...** - You have already received treatment for this cancer - You have a history of heart failure - Your blood counts or organ function do not meet the requirements 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

DRUGTislelizumab

Tislelizumab will be administered on day 1 of each cycle at 200mg once every 14 days.

DRUGOxaliplatin injection

Oxaliplatin will be administered on day 1 of each cycle at 85mg/m2 once every 14 days.

DRUGLevo-Leucovorin

Levo-Leucovorin will be administered on day 1 of each cycle at 200 mg/m2 once every 14 days.

DRUG5-fluorouracil

5-fluorouracil will be administered at 2400 mg/m2 over 46-hour every 14 days.

DRUGPaclitaxel

Paclitaxel will be administered on day 1 of each cycle at 135mg/m2


Locations(1)

Fujian cancer hospital

Fuzhou, Fujian, China

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NCT06793917


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