Tislelizumab with FOLFOX versus POF for unresectable or metastatic gastric/gastroesophageal junction adenocarcinoma

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

This trial tests whether adding the immunotherapy drug tislelizumab to FOLFOX works better than adding it to POF for adults with unresectable or metastatic stomach or gastroesophageal junction cancer whose tumors have CPS≥1.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 269 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Fujian Cancer Hospital (Government)
• Drugs / interventions: Tislelizumab, chemotherapy, immunotherapy
• Locations: 1 site (Fuzhou, Fujian)
• Trial ID: NCT06793917 on ClinicalTrials.gov

What this trial studies

This is a randomized, open-label Phase III comparison of two tislelizumab-containing chemotherapy combinations in patients with untreated locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma with CPS≥1. Eligible adults (18–70 years) with ECOG 0–1 and adequate organ function are randomized to receive tislelizumab plus FOLFOX or tislelizumab plus POF. Treatment continues until disease progression or unacceptable toxicity, with scheduled imaging and laboratory monitoring. The trial captures tumor response, survival outcomes, and safety/adverse event data.

Who should consider this trial

Good fit: Adults aged 18–70 with histologically confirmed unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, CPS≥1, ECOG performance status 0–1, no prior systemic chemotherapy or immunotherapy (with defined perioperative exceptions), and adequate marrow, liver, and renal function are ideal candidates.

Not a fit: Patients older than 70, with ECOG >1, inadequate organ function, recent systemic chemotherapy or immunotherapy, or tumors with CPS <1 are unlikely to qualify or benefit from this trial.

Why it matters

Potential benefit: If successful, the combination could improve response rates and survival compared with current chemotherapy approaches for CPS≥1 advanced gastric/GEJ cancer.

How similar studies have performed: Other PD‑1 inhibitor plus chemotherapy combinations (for example, nivolumab plus chemotherapy) have shown improved survival in advanced gastric/GEJ cancer, so this approach has supporting evidence.

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.

Where this trial is running

Fuzhou, Fujian

• Fujian cancer hospital — Fuzhou, Fujian, China (Recruiting)

Study contacts

• Principal investigator: Rong bo Lin, bachelor — Fujian Cancer Hospital
• Study coordinator: Rong bo Lin, bachelor

Conditions Gastric Cancer