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Recruiting Phase 2 NCT06168786

Cadonilimab Combined With Fruquintinib and SBRT as Athird-line and Posterior Line Treatment in Patients With MSS CRC

Trial Parameters

Condition Colorectal Cancer
Sponsor Huazhong University of Science and Technology
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 40
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2023-06-20
Completion 2026-02-28
Interventions
FruquintinibCadonilimabSBRT

Brief Summary

A Phase II Study to Assess the Efficacy and Safety of Cadonilimab Combined With Fruquintinib and SBRT as A third-line and Posterior Line Treatment in Patients With MSS Colorectal Cancer

Eligibility Criteria

Inclusion Criteria: * Provision of written Informed Consent Form (ICF) prior to any study specific procedures * Age ≥ 18 years, ≤75 years * Histologically or cytologically confirmed advanced Stage IV primary colorectal cancer * MSI status: MSS * At least two or more standard systemic therapies prior treatment (based on Fu, oxaliplatin, irinotecan, bevacizumab and cetuximab) of cytotoxic chemotherapy, treatment failure or intolerable toxicities * ECOG 0-1 * Patients must have measurable lesions * Expected overall survival ≥12 weeks * AST, ALT and alkaline phosphatase ≤ 2.5 times the upper limit of normal (ULN),Serum bilirubin ≤ 1.5 x ULN,creatinine\<ULN * Prothrombin time (PT), international standard ratio (INR) ≤1.5 × ULN * Patients are allowed to have received radiotherapy, but the time from entering the group must be more than 4 weeks, and the currently selected radiotherapy lesions and evaluable lesions must be lesions that have not received radiotherapy * Fertile male or female pat

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