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Cadonilimab Combined With Fruquintinib and SBRT as Athird-line and Posterior Line Treatment in Patients With MSS CRC | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

A Phase II, Single-arm, Open-label, Multi-Centers Study of Cadonilimab Combined With Fruquintinib and SBRT as A Third-line and Posterior Line Treatment in Patients With MSS Colorectal Cancer

NCT06168786•Huazhong University of Science and Technology

View on ClinicalTrials.gov

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

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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
+2 more criteria

Exclusion Criteria

•Patients have received anti-PD-1 / PD-L1 or anti-CTLA-4 immunotherapy or other immunoexperimental drugs
•Patients with severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease and ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (such as Wegener's granuloma), etc
•Symptomatic interstitial lung disease or active infection/non-infectious pneumonia
•Risk factors of intestinal perforation: active diverticulitis, abdominal abscess, gastrointestinal obstruction, abdominal cancer or other known risk factors of intestinal perforation
•If the patients underwent surgery, they should wait for the wound to heal completely before being considered for enrollment
•History of other malignant tumors（(except for the cured localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder carcinoma, prostate carcinoma in situ, cervical carcinoma in situ, and breast carcinoma in situ）
•Patients who are preparing for or have previously received an organ or allogeneic bone marrow transplant
•Moderate or severe ascites with clinical symptoms required therapeutic puncture, drainage or Child-Pugh score \>2 (except those who only show a small amount of ascites on imaging without clinical symptoms); Uncontrolled or moderate or higher pleural effusion or pericardial effusion
•History of gastrointestinal bleeding or a definite tendency to gastrointestinal bleeding within 6 months before the start of treatment
•Abdominal fistula, gastrointestinal perforation, or abdominal abscess developed within 6 months before the start of study treatment
+28 more criteria

Locations (1)

Huazhong University of Science and Technology

Wuhan, Hubei, China

Key Dates

Start Date

June 20, 2023

Primary Completion Date

February 28, 2026

Completion Date

February 28, 2027

Last Updated

December 21, 2023

Enrollment

ESTIMATED participants

Conditions

Colorectal Cancer

Interventions

Fruquintinib

DRUG

Cadonilimab

DRUG

SBRT

RADIATION

Contacts

Xianglin Yuan

CONTACT

13667241722 xlyuan1020@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 21, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

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