Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma

Summary

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.

Timeline

Start

2018-12-13

Primary completion

2023-02-28

Completion

2024-08-27

Publications

• Rha 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 Jun 29:1-11. doi: 10.1080/03007995.2026.2686048. Online ahead of print.
• Kato 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.
• Qiu 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.
• Cruz-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.
• Cruz-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.
• Moehler M, Oh DY, Kato K, Arkenau T, Tabernero J, Lee KW, Rha SY, Hirano H, Spigel D, Yamaguchi K, Wyrwicz L, Disel U, Pazo-Cid RA, Fornaro L, Xu Y, Sheng T, Yang S, Kadva A, Cruz-Correa M, Xu RH. First-Line Tislelizumab Plus Chemotherapy for Advanced Gastric Cancer with Programmed Death-Ligand 1 Expression >/= 1%: A Retrospective Analysis of RATIONALE-305. Adv Ther. 2025 May;42(5):2248-2268. doi: 10.1007/s12325-025-03133-7. Epub 2025 Mar 13.
• Li W, Wan L, Zhang J. Cost-effectiveness of tislelizumab plus chemotherapy vs chemotherapy as first-line treatment of PD-L1 positive advanced gastric or gastroesophageal junction adenocarcinoma from a Chinese perspective. Expert Rev Gastroenterol Hepatol. 2024 Jun;18(6):293-301. doi: 10.1080/17474124.2024.2373730. Epub 2024 Jun 28.
• Qiu MZ, Oh DY, Kato K, Arkenau T, Tabernero J, Correa MC, Zimina AV, Bai Y, Shi J, Lee KW, Wang J, Poddubskaya E, Pan H, Rha SY, Zhang R, Hirano H, Spigel D, Yamaguchi K, Chao Y, Wyrwicz L, Disel U, Cid RP, Fornaro L, Evesque L, Wang H, Xu Y, Li J, Sheng T, Yang S, Li L, Moehler M, Xu RH; RATIONALE-305 Investigators. Tislelizumab plus chemotherapy versus placebo plus chemotherapy as first line treatment for advanced gastric or gastro-oesophageal junction adenocarcinoma: RATIONALE-305 randomised, double blind, phase 3 trial. BMJ. 2024 May 28;385:e078876. doi: 10.1136/bmj-2023-078876.

Drugs

Indications