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

Last Updated: 2025-07-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 269 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-07
• Study Completion Date: 2029-04-01

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

Conditions

Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tislelizumab combined with POF

Group Type: EXPERIMENTAL

Tislelizumab

Intervention Type: DRUG

Tislelizumab will be administered on day 1 of each cycle at 200mg once every 14 days.

Oxaliplatin injection

Intervention Type: DRUG

Oxaliplatin will be administered on day 1 of each cycle at 85mg/m2 once every 14 days.

Levo-Leucovorin

Intervention Type: DRUG

Levo-Leucovorin will be administered on day 1 of each cycle at 200 mg/m2 once every 14 days.

5-fluorouracil

Intervention Type: DRUG

5-fluorouracil will be administered at 2400 mg/m2 over 46-hour every 14 days.

Paclitaxel

Intervention Type: DRUG

Paclitaxel will be administered on day 1 of each cycle at 135mg/m2

Tislelizumab combined with mFOLFOX6

Group Type: EXPERIMENTAL

Tislelizumab

Intervention Type: DRUG

Tislelizumab will be administered on day 1 of each cycle at 200mg once every 14 days.

Oxaliplatin injection

Intervention Type: DRUG

Oxaliplatin will be administered on day 1 of each cycle at 85mg/m2 once every 14 days.

Levo-Leucovorin

Intervention Type: DRUG

Levo-Leucovorin will be administered on day 1 of each cycle at 200 mg/m2 once every 14 days.

5-fluorouracil

Intervention Type: DRUG

5-fluorouracil will be administered at 2400 mg/m2 over 46-hour every 14 days.

Interventions

Tislelizumab

Tislelizumab will be administered on day 1 of each cycle at 200mg once every 14 days.

Intervention Type: DRUG

Oxaliplatin injection

Oxaliplatin will be administered on day 1 of each cycle at 85mg/m2 once every 14 days.

Intervention Type: DRUG

Levo-Leucovorin

Levo-Leucovorin will be administered on day 1 of each cycle at 200 mg/m2 once every 14 days.

Intervention Type: DRUG

5-fluorouracil

5-fluorouracil will be administered at 2400 mg/m2 over 46-hour every 14 days.

Intervention Type: DRUG

Paclitaxel

Paclitaxel will be administered on day 1 of each cycle at 135mg/m2

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rong bo Lin, bachelor

Role: PRINCIPAL_INVESTIGATOR

Fujian Cancer Hospital

Locations

Fujian cancer hospital

Fuzhou, Fujian, China

Site Status: RECRUITING

Countries

China

Central Contacts

Rong bo Lin, bachelor

Role: CONTACT

rongbo_lin@163.com

13705919382 ext. 86

Facility Contacts

Lin ron bo, bachelor

Role: primary

Other Identifiers

SYLT-030

Identifier Type: -

Identifier Source: org_study_id