Sacituzumab Govitecan Combined With Tislelizumab for Locally Advanced/Metastatic Esophageal Cancer

Summary

This is a prospective, single-center, single-arm Phase II clinical study designed to evaluate the efficacy and safety of sacituzumab tirumotecan in combination with tislelizumab in patients with advanced esophageal squamous cell carcinoma whose disease has progressed following first-line immunotherapy.

Timeline

Start

2026-07-30

Primary completion

2027-12-31

Completion

2028-12-31

Publications

• Background Zhu X, Ma X, Li H, Zhang M, Cheng Y, Wu J, Yu W, Feng W, Zhao L, Li Z, Fu X, Liu J. The efficacy and safety of anlotinib plus PD-1 inhibitor in locally advanced/metastatic esophageal squamous cell carcinoma (ESCC) patients who progressed on prior immune checkpoint inhibitors (ICIs): a retrospective real-world study (NCT 04984096). Ann Med. 2025 Dec;57(1):2443811. doi: 10.1080/07853890.2024.2443811. Epub 2024 Dec 23.
• Background Xu J, Kato K, Raymond E, Hubner RA, Shu Y, Pan Y, Park SR, Ping L, Jiang Y, Zhang J, Wu X, Yao Y, Shen L, Kojima T, Gotovkin E, Ishihara R, Wyrwicz L, Van Cutsem E, Jimenez-Fonseca P, Lin CY, Wang L, Shi J, Li L, Yoon HH. Tislelizumab plus chemotherapy versus placebo plus chemotherapy as first-line treatment for advanced or metastatic oesophageal squamous cell carcinoma (RATIONALE-306): a global, randomised, placebo-controlled, phase 3 study. Lancet Oncol. 2023 May;24(5):483-495. doi: 10.1016/S1470-2045(23)00108-0. Epub 2023 Apr 17.
• Background Xiong A, Yao W, Zheng W, Yu Y, Chen P, Zhong H, Ge J, Wang H, Chen B, Wang H, Fan Y, Yang Y, Pu X, Song X, Wang Q, Du X, Huang Z, Li X, Luo H, Yao Y, Yu Q, Su C, He L, Jiang G, Cui J, Liu C, Yi T, Che G, Liu Z, Zhang L, Zhou M, Fang Y, Wei Y, Qing Y, Jin X, Zhou C. Sacituzumab tirumotecan plus pembrolizumab versus pembrolizumab in PD-L1-positive advanced non-small-cell lung cancer (OptiTROP-Lung05): interim analysis of a randomised, open-label, phase 3 trial. Lancet. 2026 Jun 27;407(10548):2607-2619. doi: 10.1016/S0140-6736(26)00968-2. Epub 2026 May 29.

Drugs

Indications