NCT04196465

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

Phase II Study of Neoadjuvant Immune Checkpoint Inhibitor in Patients With Resectable Gastrointestinal Cancers(Neo-Chance Study)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. The sample size of the study is determined based on a major pathologic response rate (primary endpoint) and by using Simon's single stage design from the subjects who receive preoperative neoadjuvant therapy of IMC-001. In each cancer cohort group, the null and alternative response rates are assumed as 5% and 20%, respectively. This provides a power of 80% when calculating the difference between major pathologic response rates of 5% and 20% in two-tailed significance level of 0.153 (Type I error\[two-tailed\] of 15.3%). In order to reject the null hypothesis, at least two major pathological respondents are needed among 14 assessable subjects for each cancer cohort. After choosing the margin of safety as 10%, each cancer cohort will require 16 subjects and therefore a total of 48 subjects will be enrolled into the study.

Conditions

• Subjects With Resectable and Localized Gastric Cancer
• Subjects With Resectable Esophageal Cancer or Liver Cancer
• Subjects With Resectable Liver Cancer

Interventions

Type	Name	Description
DRUG	IMC-001	IMC-001 is a fully human anti-programmed cell death ligand 1 (PD-L1) recombinant monoclonal antibody that strongly binds to PD-L1 to inhibit its binding to programmed cell death protein 1 (PD-1) or B7-1 (CD80). IMC-001 showed robust dose-dependent efficacy in animal models and no evidence of toxicity in cynomolgus monkeys

Timeline

• Start date: 2019-09-09
• Primary completion: 2026-09-09
• Completion: 2026-09-26
• First posted: 2019-12-12
• Last updated: 2025-04-10

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated drug study