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

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

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer
• Intervention / Treatment: Drug: Levo-Leucovorin; Drug: 5-fluorouracil; Drug: Tislelizumab; Drug: Oxaliplatin injection; Drug: Paclitaxel

• Study Type: Interventional
• Enrollment (Estimated): 269
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Rong bo Lin, bachelor; Phone Number: 86 13705919382; Email: rongbo_lin@163.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350500
      • Recruiting
      • Fujian Cancer Hospital
      • Contact: Lin ron bo, bachelor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with advanced unresectable, histologically confirmed adenocarcinoma of the gastric or gastroesophageal junction.
• 18-70yeas.
• ECOG PS 0-1.
• No previous chemotherapy (perioperative chemotherapy, six months after fluorouracil alone or one year after oxaliplatin or a combination of taxoid and fluorouracil can be included), radiotherapy or immunotherapy.
• With normal marrow, liver and renal function: a hemoglobin (HGB) of ≥100g/L (without blood transfusion during 14 days); a leucopenia count of ≥4.0×109/L; a platelet count of ≥100×109/L; a total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL); a creatinine (Cr) of ≤ 1.5 UNL; a creatinine clearance rate ≥ 50ml/min (Cockcroft-Gault); a alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of ≤2.5 UNL or ≤5 UNL in case of liver metastasis.
• Life expectancy ≥3 months.
• With normal electrocardiogram results and no history of congestive heart failure.
• With normal coagulation function: activated partial thromboplastin time (APTT), prothrombin time (PT) and INR, each ≤ 1.5 x ULN.
• Female subjects of child-bearing potential must agree to use contraceptive measures starting 1 week before the administration of the first dose of Tislelizumab until 8 weeks after discontinuing study drug. Male subjects must agree to use contraceptive measures during the study and 8 weeks after last dose of study drug.
• With written informed consent signed voluntarily by patients themselves or their supervisors witted by doctors.
• Have a known PD-L1 CPS/MMR (or MSI) /HER2(FISH) test result, or have sufficient samples for relevant testing.

Exclusion Criteria:

• Patients with a history of another neoplastic disease within the past three years, excluding basal cell carcinoma of the skin, cervical carcinoma in situ, or nonmetastatic prostate cancer.
• Patients with brain or central nervous system metastases, including leptomeningeal disease.
• Pregnant (positive pregnancy test) or breast feeding.
• Serious, non-healing wound, ulcer, or bone fracture.
• Significant cardiac disease as defined as: unstable angina, New York Heart Association (NYHA) grade II or greater, congestive heart failure, history of myocardial infarction within 6 months Evidence of bleeding diathesis or coagulopathy.
• History of a stroke or CVA within 6 months.
• Clinically significant peripheral vascular disease.
• HIV-positive, active hepatitis B or C (HBV, HCV);
• Inability to comply with study and/or follow-up procedures.
• Patients with any other medical condition or reason, in that investigator's opinion, makes the patient unstable to participate in a clinical trial.
• Her2-positive (IHC 3+ or 2+/FISH+) patients.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tislelizumab combined with POF	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: 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: Paclitaxel; Paclitaxel will be administered on day 1 of each cycle at 135mg/m2
Experimental: Tislelizumab combined with mFOLFOX6	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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression free survival	The length of time from enrollment until the time of progression of disease (PFS, progression-free survival)	4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate	Clinical response of treatment according to RESIST v1.1 criteria (ORR, objective response rate)	every 4 weeks
Overall survival	The length of time from enrollment until the time of death (OS, overall survival).	4 years

Collaborators and Investigators

• Sponsor: Fujian Cancer Hospital
• Investigators: Principal Investigator: Rong bo Lin, bachelor, Fujian Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: January 21, 2025
• First Submitted That Met QC Criteria: January 21, 2025
• First Posted (Actual): January 27, 2025

Study Record Updates

• Last Update Posted (Actual): July 20, 2025
• Last Update Submitted That Met QC Criteria: July 16, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Adenocarcinoma; Antineoplastic Agents, Immunological; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Micronutrients; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Protective Agents; Antidotes; Vitamin B Complex; Vitamins; Oxaliplatin; Tislelizumab; Fluorouracil; Leucovorin; Levoleucovorin; Paclitaxel
• Other Study ID Numbers: SYLT-030

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No