RecruitingPhase 2NCT05229003

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)


Sponsor

Fudan University

Enrollment

44 participants

Start Date

Mar 9, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding the drugs anlotinib (a targeted anti-angiogenesis drug) and/or penpulimab (an immunotherapy drug) to standard irinotecan chemotherapy improves outcomes for patients with colorectal cancer that has spread and stopped responding to first-line treatment. **You may be eligible if...** - You have confirmed metastatic or recurrent colorectal adenocarcinoma - Your cancer progressed after a first-line treatment that included oxaliplatin and fluorouracil - You are in reasonably good general health - You have not received irinotecan previously **You may NOT be eligible if...** - You have had more than one prior line of chemotherapy for metastatic disease - You have uncontrolled brain metastases - You have serious heart, liver, or kidney problems - You have active autoimmune disease requiring treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAnlotinib

Anlotinib 8mg or 10mg, d1-9,q2w

DRUGPenpulimab

Penpulimab 200mg, d6, q2w

DRUGIrinotecan

Irinotecan 180mg/m2, d6, q2w


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT05229003


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