Clinical trial · Interventional
Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Clinical Study Comparing the Efficacy and Safety of Tislelizumab (BGB-A317) Plus Platinum and Fluoropyrimidine Versus Placebo Plus Platinum and Fluoropyrimidine as First-Line Treatment in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
NCT03777657CI-TRIAL-00086052completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study was designed to compare the efficacy and safety of tislelizumab plus chemotherapy versus placebo plus chemotherapy as the first treatment (first-line) for adults diagnosed with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric, or Gastroesophageal Junction Adenocarcinoma | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Fluorouracil | Drug | Fluorouracil | ALIAS |
| Capecitabine | Drug | Capecitabine | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
| Tislelizumab | Drug | Tislelizumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tislelizumab + Chemotherapy
- description
- Participants received 200 mg of tislelizumab intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Chemotherapy consisted of 1000 mg/m² capecitabine twice daily on Days 1-14 and 130 mg/m² oxaliplatin on Day 1, or 800 mg/m² 5-fluorouracil (5-FU) on Days 1-5 and 80 mg/m² cisplatin on Day 1 of each 21-day cycle. Thereafter, participants continued treatment with 200 mg tislelizumab, with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity.
- interventionNames
- Drug: Tislelizumab
- Drug: Cisplatin
- Drug: Oxaliplatin
- Drug: Capecitabine
- Drug: 5-Fluorouracil
- type
- PLACEBO_COMPARATOR
- label
- Placebo + Chemotherapy
- description
- Participants received placebo intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Chemotherapy consisted of 1000 mg/m² capecitabine twice daily on Days 1-14 and 130 mg/m² oxaliplatin on Day 1, or 800 mg/m² 5-FU on Days 1-5 and 80 mg/m² cisplatin on Day 1 of each 21-day cycle. Thereafter, participants continued treatment with placebo with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: 1. Locally advanced unresectable or metastatic gastric cancer (GC) or gastroesophageal junction (GEJ) carcinoma and have histologically confirmed adenocarcinoma 2. No previous systemic therapy for locally advanced unresectable or metastatic gastric/GEJ cancer. NOTE: Participants may have received prior neoadjuvant or adjuvant therapy as long as it was completed and have no recurrence or disease progression for at least 6 months. 3. Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 1 within 7 days prior to randomization 4. Adequate organ function ≤ 7 days prior to randomization Key Exclusion Criteria: 1. Has squamous cell or undifferentiated or other histological type GC 2. Active leptomeningeal disease or uncontrolled brain metastasis 3. Diagnosed with gastric or GEJ adenocarcinoma with positive HER2 4. Prior therapy with an anti-programmed cell death protein-1 (PD-1), anti-programmed cell death protein ligand-1 (PD-L1), anti-programmed cell death protein ligand-2 (PD-L2), or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
References
Publications (8)
- DERIVEDRha SY, Ryu MH, Kim JG, Xu S, Xu Y, Lee KW. Comparative efficacy of tislelizumab + FOLFOX or CAPOX for gastric/gastroesophageal junction adenocarcinoma: an exploratory matching-adjusted indirect comparison. Curr Med Res Opin. 2026 May;42(5):1031-1041. doi: 10.1080/03007995.2026.2686048. Epub 2026 Jun 29. PMID 42371751
- DERIVEDKato K, Xu RH, Oh DY, Bai Y, Shi J, Lee KW, Hirano H, Xu H, Sheng T, B Barnes F, Barnes G. Tislelizumab plus chemotherapy vs placebo plus chemotherapy as first-line treatment of advanced gastric or gastroesophageal junction adenocarcinoma: patient-reported outcomes in the Asian subgroup of the RATIONALE-305 study. Curr Med Res Opin. 2026 Apr;42(4):809-819. doi: 10.1080/03007995.2026.2682010. Epub 2026 Jun 9. PMID 42262249
- DERIVEDQiu MZ, Lee KW, Mohler M, Luo HY, Hirano H, Zhang T, Wang FH, Ba Y, Rha SY, Wang F, He MM, Xu S, Pan X, Xu RH. Tislelizumab plus chemotherapy versus placebo plus chemotherapy as first-line treatment in patients with advanced gastric or gastroesophageal junction adenocarcinoma, with or without peritoneal metastases: a post-hoc analysis on RATIONALE-305 study. EClinicalMedicine. 2026 May 15;95:103980. doi: 10.1016/j.eclinm.2026.103980. eCollection 2026 May. PMID 42205142
- DERIVEDCruz-Correa M, Oh DY, Kato K, Tabernero J, Bai Y, Shi J, Lee KW, Hirano H, Spigel D, Wyrwicz L, Pazo Cid R, Cubillo Gracian A, Xu Y, Sheng T, Yang S, Xu RH, Moehler M. Tislelizumab + Chemotherapy in Gastric Cancer: Long-Term RATIONALE-305 Randomized Trial Follow-up. Adv Ther. 2026 Jan;43(1):165-183. doi: 10.1007/s12325-025-03415-0. Epub 2025 Nov 18. PMID 41251890
- DERIVEDCruz-Correa M, Xu RH, Moehler M, Oh DY, Kato K, Spigel D, Arkenau HT, Tabernero J, Zimina AV, Bai Y, Shi J, Lee KW, Hirano H, Wyrwicz L, Cid RP, Xu H, Sheng T, Barnes G. Tislelizumab plus chemotherapy versus placebo plus chemotherapy as first-line treatment of advanced gastric or gastroesophageal junction adenocarcinoma: patient-reported outcomes in the RATIONALE-305 study. Curr Med Res Opin. 2025 Jun;41(6):1007-1016. doi: 10.1080/03007995.2025.2501588. Epub 2025 Jun 18.