Phase II Study of Neoadjuvant Immune Checkpoint Inhibitor in Patients With Resectable Gastrointestinal Cancers

Summary

This is a phase II, open-label, prospective single-centered study. Subjects who meet the inclusion/exclusion criteria will be allocated to appropriate cohorts: 1) gastric cancer, 2) esophageal cancer and 3) hepatocellular carcinoma. Each cancer cohort group will be treated with two cycles of neoadjuvant immune checkpoint inhibitor of IMC-001 (1 cycle = 2 weeks) followed by curative resection and be followed up consecutively.

Timeline

Start

2019-09-09

Primary completion

2026-09-09

Completion

2026-09-26

Outcome

Missed primary endpoint

paper The study did not meet its pre-specified primary endpoint PMID 42399382 ↗

Publications

• Bang YH, Kang D, Lee S, Kim S, Jeon I, Park E, Choi J, Song GW, Yoo MW, Song JS, Song IH, Kim YH, Kim HR, Song HJ, Kim DH, Choi KD, Lee JH, Ahn JY, Shim JH, Lee D, Choi J, Kim JE, Kim SY, Bae DJ, Park SR. Neoadjuvant Danburstotug (IMC-001) therapy in gastric, esophageal, and hepatocellular carcinoma: the NeoChance phase II study. NPJ Precis Oncol. 2026 Jul 3. doi: 10.1038/s41698-026-01571-2. Online ahead of print.

Drugs

Indications