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Recruiting 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

Phase III Interventional Gastric Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tislelizumab, Oxaliplatin injection, Levo-Leucovorin, 5-fluorouracil.
Who it may be relevant to
Registry conditions: Gastric Cancer. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Tislelizumab Plus FOLFOX Versus POF in the Treatment of Locally Advanced Unresectable or Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma

Overview

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

Interventions

  • 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

Primary outcome measures

  • progression free survival [Time frame: 4 years]
Secondary outcome measures (2)
  • Objective response rate [Time frame: every 4 weeks]
  • Overall survival [Time frame: 4 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Fujian cancer hospital — Fuzhou

Identifiers

NCT: NCT06793917 · SYLT-030

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗