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

NCT05229003 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2024-07-03

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Anlotinib

Anlotinib 8mg or 10mg, d1-9，q2w

DRUG

Penpulimab

Penpulimab 200mg, d6, q2w

DRUG

Irinotecan

Irinotecan 180mg/m2, d6, q2w

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Weijian Guo, M.D · Fudan University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-09
Primary Completion
2025-05-31
Completion
2025-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05229003 on ClinicalTrials.gov