Actively Recruiting

Phase 3
Age: 18Years - 70Years
All Genders
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

Led by Fujian Cancer Hospital · Updated on 2025-07-20

269

Participants Needed

1

Research Sites

199 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fujian cancer hospital

Fuzhou, Fujian, China, 350500

Actively Recruiting

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Research Team

R

Rong bo Lin, bachelor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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