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
1 other identifier
interventional
269
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 gastric-cancer
Started Jun 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2025
CompletedFirst Posted
Study publicly available on registry
January 27, 2025
CompletedStudy Start
First participant enrolled
June 7, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2029
July 20, 2025
July 1, 2025
2.8 years
January 21, 2025
July 16, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
progression free survival
The length of time from enrollment until the time of progression of disease (PFS, progression-free survival)
4 years
Secondary Outcomes (2)
Objective response rate
every 4 weeks
Overall survival
4 years
Study Arms (2)
Tislelizumab combined with POF
EXPERIMENTALTislelizumab combined with mFOLFOX6
EXPERIMENTALInterventions
Tislelizumab will be administered on day 1 of each cycle at 200mg once every 14 days.
Oxaliplatin will be administered on day 1 of each cycle at 85mg/m2 once every 14 days.
Levo-Leucovorin will be administered on day 1 of each cycle at 200 mg/m2 once every 14 days.
5-fluorouracil will be administered at 2400 mg/m2 over 46-hour every 14 days.
Paclitaxel will be administered on day 1 of each cycle at 135mg/m2
Eligibility Criteria
You may qualify if:
- Patients with advanced unresectable, histologically confirmed adenocarcinoma of the gastric or gastroesophageal junction.
- yeas.
- 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.
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fujian cancer hospital
Fuzhou, Fujian, 350500, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rong bo Lin, bachelor
Fujian Cancer Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2025
First Posted
January 27, 2025
Study Start
June 7, 2025
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
April 1, 2029
Last Updated
July 20, 2025
Record last verified: 2025-07