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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

NCT06793917 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 269

Last updated 2025-07-20

No results posted yet for this study

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

Interventions

DRUG

Tislelizumab

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

DRUG

Oxaliplatin injection

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

DRUG

Levo-Leucovorin

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

DRUG

5-fluorouracil

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

DRUG

Paclitaxel

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

Sponsors & Collaborators

  • Fujian Cancer Hospital

    lead OTHER_GOV

Principal Investigators

  • Rong bo Lin, bachelor · Fujian Cancer Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-07
Primary Completion
2028-04-01
Completion
2029-04-01

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06793917 on ClinicalTrials.gov