SBRT Combined With Fruquintinib Plus PD-1/CTLA-4 Antibody Cadonilimab for Third-line Treatment in Metastatic Colonrectal Cancer.

Wuhan Union Hospital, China1 site in 1 country44 target enrollmentFebruary 28, 2023

ConditionsMetastatic Colorectal Cancer

InterventionsSBRT, Fruquintinib, Cadonilimab

DrugsSBRT, Fruquintinib, Cadonilimab

Overview

Phase: Phase 2
Intervention: SBRT, Fruquintinib, Cadonilimab
Conditions: Metastatic Colorectal Cancer
Sponsor: Wuhan Union Hospital, China
Enrollment: 44
Locations: 1
Primary Endpoint: Progression free survival
Status: Not yet recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The study is a phase II clinical study. The purpose of the study is to evaluate the efficacy and safety of SBRT combined with Fruquintinib Plus PD-1/CTLA-4 Antibody for Third-line Treatment in mCRC.

Registry

clinicaltrials.gov

Start Date

February 28, 2023

End Date

December 31, 2026

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Wuhan Union Hospital, China

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients must have biopsy proven unresectable MCRC.
•Patients must have received first-line and second-line chemotherapy, and approved a progressive disease.
•Age ≥ 18 years
•Patients must have measurable disease at baseline.
•Patients can have up to only 5 discrete active extracranial lesions (≤3 in the liver and ≤3 in the lung) identified by position-emission tomography (PET) scan and also seen on correlative plain film, CT scan, or MRI within 8 weeks prior to the initiation of radiotherapy.
•Patients who previously received radiotherapy to the primary site will be ineligible if there is CT evidence of disease progression within the past 3 months.
•Patients must have a Karnofsky Performance Scores (KPS) \>60
•Aspartate aminotransferase, alanine aminotransferase \& Alkaline phosphates must be ≤ 2.5 times the upper limit of normal (ULN). Total bilirubin must be within the limit of normal.
•Patients should have adequate bone marrow function as defined by peripheral granulocyte count of ≥1500/mm
•Patients should have adequate renal function (serum creatinine ≤1.5 times the ULN).

Exclusion Criteria

•Patients with either untreated brain metastases or brain metastases treated within the past three months are ineligible
•Patients with serious, uncontrolled, concurrent infection(s).
•Significant weight loss (\>10%) in the prior 3 months.
•Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cancers.
•Patients with more than 5 discrete metastatic lesions.
•Participation in any investigational drug study within 4 weeks preceding the start of study treatment.
•Unwillingness to participate or inability to comply with the protocol for the duration of the study.
•Patients who are pregnant. Patients with reproductive capability will need to use adequate contraception during the time of participation in the study