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
| NCT ID | NCT06793917 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Fujian Cancer Hospital |
| Condition | Gastric Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 269 participants |
| Start Date | 2025-06-07 |
| Primary Completion | 2028-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 269 participants in total. It began in 2025-06-07 with a primary completion date of 2028-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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.
Contact & Investigator
Rong bo Lin, bachelor
PRINCIPAL INVESTIGATOR
Fujian Cancer Hospital
Frequently Asked Questions
Who can join the NCT06793917 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Gastric Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06793917 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 269 participants.
Is NCT06793917 currently recruiting?
Yes, NCT06793917 is actively recruiting participants. Contact the research team at rongbo_lin@163.com for enrollment information.
Where is the NCT06793917 trial being conducted?
This trial is being conducted at Fuzhou, China.
Who is sponsoring the NCT06793917 clinical trial?
NCT06793917 is sponsored by Fujian Cancer Hospital. The principal investigator is Rong bo Lin, bachelor at Fujian Cancer Hospital. The trial plans to enroll 269 participants.
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