Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Irinotecan

Topoisomerase I Inhibitors

Enzyme Inhibitors

Anlotinib + Irinotecan:

Anlotinib, 10mg, oral, once daily, D1-10, q2W; Irinotecan, 180mg/m2, iv drip, d6, q2w.

Anlotinib + Penpulimab + Irinotecan:

Anlotinib, 8mg, oral, once daily, d1-10, q2w; Penpulimab 200mg, i.v. d6, q2w; Irinotecan, 180mg/m2, iv infusion, d6, q2w.

Anlotinib

Penpulimab

Chenchen Wang, M.D

Chenchen Wang, MD

Weijian Guo, MD,PhD

Weijian Guo, M.D

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.

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=20), 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 3 out of 20 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 44 patients were planned to be enrolled in this study. It is expected to start in February 2022, with recruitment ending in January 2023 and follow-up ending in January 2024.

Patients were first enrolled into cohort A, and when the efficacy of cohort A reached a certain percentage, the enrollment of cohort B started then.

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)

the adverse events of all enrolled patients

Fudan University

Director of Department of Medical Gastrointestinal Oncology

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Irinotecan Plus Anlotinib or Further in Combination With Penpulimab for Second-line Treatment of mCRC	NCT05229003	Metastatic Colo...	Anlotinib Penpulimab Irinotecan	18 Years - 85 Years	Fudan University
Irinotecan Plus Anlotinib or Further in Combination With Penpulimab for Second-line Treatment of mCRC	NCT05229003	Metastatic Colo...	Anlotinib Penpulimab Irinotecan	18 Years - 85 Years	Fudan University

Spots Global Cancer Trial Database for enlotinib

Every month we try and update this database with for enlotinib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for enlotinib

Every month we try and update this database with for enlotinib cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for enlotinib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.