NCT06793917

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 269 (estimated)
• Sponsor: Fujian Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	Tislelizumab	Tislelizumab will be administered on day 1 of each cycle at 200mg once every 14 days.
DRUG	Oxaliplatin injection	Oxaliplatin will be administered on day 1 of each cycle at 85mg/m2 once every 14 days.
DRUG	Levo-Leucovorin	Levo-Leucovorin will be administered on day 1 of each cycle at 200 mg/m2 once every 14 days.
DRUG	5-fluorouracil	5-fluorouracil will be administered at 2400 mg/m2 over 46-hour every 14 days.
DRUG	Paclitaxel	Paclitaxel will be administered on day 1 of each cycle at 135mg/m2

Timeline

• Start date: 2025-06-07
• Primary completion: 2028-04-01
• Completion: 2029-04-01
• First posted: 2025-01-27
• Last updated: 2025-07-20

Locations

1 site across 1 country: China