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OncoMatch/Clinical Trials/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

Is NCT06793917 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments for gastric cancer.

Phase 3RecruitingFujian Cancer HospitalNCT06793917Data as of Jun 2026Location: China

Treatment: Tislelizumab · Oxaliplatin · Levo-Leucovorin · 5-fluorouracil · PaclitaxelTo 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

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Extracted eligibility criteria

Treatments studied

Immunotherapy

Tislelizumab

Chemotherapy

Oxaliplatin5-fluorouracilPaclitaxel

Other

Levo-Leucovorin

Cancer type

Gastric Cancer

Biomarker criteria

Required: PD-L1 (CD274) CPS testing required (testing required; no eligibility threshold specified)

Have a known PD-L1 CPS/MMR (or MSI) /HER2(FISH) test result, or have sufficient samples for relevant testing

Required: MMR testing required (testing required; no eligibility threshold specified)

Have a known PD-L1 CPS/MMR (or MSI) /HER2(FISH) test result, or have sufficient samples for relevant testing

Required: MSH2 testing required (testing required; no eligibility threshold specified)

Have a known PD-L1 CPS/MMR (or MSI) /HER2(FISH) test result, or have sufficient samples for relevant testing

Required: HER2 (ERBB2) testing required (testing required; no eligibility threshold specified)

Have a known PD-L1 CPS/MMR (or MSI) /HER2(FISH) test result, or have sufficient samples for relevant testing

Excluded: HER2 (ERBB2) overexpression

Her2-positive (IHC 3+ or 2+/FISH+) patients

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 70

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: chemotherapy

Exception: perioperative chemotherapy, six months after fluorouracil alone or one year after oxaliplatin or a combination of taxoid and fluorouracil can be included

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)

Cannot have received: radiotherapy

No previous...radiotherapy

Cannot have received: immunotherapy

No previous...immunotherapy

Lab requirements

Blood counts

hemoglobin (HGB) of ≥100g/L (without blood transfusion during 14 days); leucopenia count of ≥4.0×10^9/L; platelet count of ≥100×10^9/L

Kidney function

creatinine (Cr) of ≤ 1.5 UNL; creatinine clearance rate ≥ 50ml/min (Cockcroft-Gault)

Liver function

total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL); alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of ≤2.5 UNL or ≤5 UNL in case of liver metastasis

Cardiac function

normal electrocardiogram results and no history of congestive heart failure

With normal marrow, liver and renal function: a hemoglobin (HGB) of ≥100g/L (without blood transfusion during 14 days); a leucopenia count of ≥4.0×10^9/L; a platelet count of ≥100×10^9/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. With normal electrocardiogram results and no history of congestive heart failure.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT06793917 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Does this trial require CD274?

Yes, CD274 CPS testing required is a required biomarker for enrollment.

Does this trial require MMR?

Yes, MMR testing required is a required biomarker for enrollment.

Does this trial require MSH2?

Yes, MSH2 testing required is a required biomarker for enrollment.

Are patients with ERBB2 alterations eligible?

No. ERBB2 overexpression is an exclusion criterion.

Is there an age limit?

Yes. Patients must be 70 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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