NCT05229003

Irinotecan Plus Anlotinib or Further in Combination With Penpulimab for Second-line Treatment of mCRC

A Randomized, Uncontrolled, Exploratory Phase 2 Trial of Irinotecan Plus Anlotinib or Further in Combination With Penpulimab as Second-line Treatment of Metastatic Colorectal Cancer (ZL-IRIAN)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is an exploratory, non-controlled, multi-cohort, phase II small-sample clinical study designed to evaluate the clinical benefit of second-line treatment with anlotinib plus irinotecan or further in combination with a PD-1 monoclonal antibody (penpulimab) in patients with advanced colorectal cancer after first-line treatment failure. To explore the rationality of the combination of chemotherapy and targeted therapy and immunotherapy strategy and obtain relevant survival and safety data. The study will fully evaluate the efficacy, PFS, OS, safety and related biomarkers of the regimen.

Detailed description

The design of this study is an open, non-controlled, multi-cohort, phase II, small-sample prospective clinical study, including eligible patients with metastatic colorectal cancer who received the second-line treatment, and two cohort were included, Cohort A received anlotinib and irinotecan chemotherapy (n=23), and the treatment of cohort B consisted of anlotinib and anti-PD-1 mab (penpulimab) plus irinotecan chemotherapy. Patients were firstly enrolled in cohort A, and if patients in cohort A achieved an response rate of no less than 15% (i.e., no less than 4 out of 23 patients receiving efficacy evaluation achieved CR/PR), the following patients would be enrolled in cohort B. If the response rate of patients in cohort A was less than 15%, subsequent cohort B enrollment (non-control) would be stopped. A total of 46 patients enrolled in this study, actually.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Anlotinib	Anlotinib 8mg or 10mg, d1-9，q2w
DRUG	Penpulimab	Penpulimab 200mg, d6, q2w
DRUG	Irinotecan	Irinotecan 180mg/m2, d6, q2w

Timeline

• Start date: 2022-03-09
• Primary completion: 2025-05-31
• Completion: 2025-12-31
• First posted: 2022-02-08
• Last updated: 2024-07-03

Locations

1 site across 1 country: China