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Clinical Trials in China / NCT06793917
Recruiting Phase 3

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

NCT06793917 · tracked via the Priya Life Science China tracker
Sponsor
Fujian Cancer Hospital
Phase
Phase 3
Started
2025-06-07
Last updated
2025-07-20

Condition(s) studied

Gastric Cancer

Investigational drug(s) / intervention(s)

Tislelizumab →Oxaliplatin injection →Levo-Leucovorin →5-fluorouracil →Paclitaxel →

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

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

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

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

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

Study 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

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Fujian cancer hospital Fuzhou Fujian Recruiting

More Fujian Cancer Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06793917 on ClinicalTrials.gov ↗ ← All trials in China