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

Phase 3

Not yet recruiting

• Conditions: Gastric Cancer
• Interventions: Drug: Tislelizumab; Drug: Oxaliplatin injection; Drug: Levo-Leucovorin; Drug: 5-fluorouracil; Drug: Paclitaxel

• Registration Number: NCT06793917
• Lead Sponsor: Fujian Cancer Hospital

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-21
• Study First Submitted QC: 2025-01-21
• Last Update Submitted: 2025-01-21
• Study First Posted: 2025-01-27
• Last Update Posted: 2025-01-27
• Study Start: 2025-04-01
• Primary Completion: 2028-04-01
• Study Completion: 2029-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 269

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tislelizumab combined with POF	Tislelizumab	-
Tislelizumab combined with POF	5-fluorouracil	-
Tislelizumab combined with POF	Oxaliplatin injection	-
Tislelizumab combined with POF	Levo-Leucovorin	-
Tislelizumab combined with POF	Paclitaxel	-
Tislelizumab combined with mPOLFOX6	Tislelizumab	-
Tislelizumab combined with mPOLFOX6	Levo-Leucovorin	-
Tislelizumab combined with mPOLFOX6	Oxaliplatin injection	-
Tislelizumab combined with mPOLFOX6	5-fluorouracil	-

Primary Outcome Measures

Name	Time	Method
progression free survival	4 years	The length of time from enrollment until the time of progression of disease (PFS, progression-free survival)

Secondary Outcome Measures

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