RecruitingPhase 2NCT06356584

Fruquintinib Combined With Sintilimab ± Radiotherapy for Third-line Treatment of Colorectal Cancer With Liver Metastases

Fruquintinib Combined With Sintilimab ± Radiotherapy for Third-line Treatment of Colorectal Cancer With Liver Metastases: A Randomized, Controlled, Multicenter Phase II Trial


Sponsor

Shandong Cancer Hospital and Institute

Enrollment

62 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Colorectal cancer (CRC) is a significant cause of morbidity and mortality worldwide. Its early clinical manifestations are often subtle, leading to late-stage diagnosis in about 30% of cases with distant metastases. Liver metastases are widespread and associated with poor prognosis, especially in terms of response to immunotherapy. This prospective study will evaluate the efficacy of combined therapy involving sintilimab, fruquintinib, and radiotherapy in CRC with liver metastases. The primary objectives are to assess progression-free survival, overall survival, and treatment response rates. This study aims to provide valuable insights into optimizing third-line and subsequent therapies for CRC with liver metastases by elucidating the efficacy and safety of this combined treatment approach.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether combining two drugs — fruquintinib (a targeted therapy) and sintilimab (an immunotherapy) — with or without radiation to the liver, can help patients with colorectal cancer that has spread to the liver and stopped responding to two prior lines of treatment. **You may be eligible if...** - You are an adult with confirmed colorectal adenocarcinoma that has spread to the liver - Your tumor is the MSS/pMMR type (a specific genetic subtype) - You have already received two rounds of standard chemotherapy that have not worked - You have measurable cancer on imaging and your organs are functioning well - You have not previously received immunotherapy (anti-PD-1/PD-L1) or fruquintinib - You have an expected survival of at least 3 months **You may NOT be eligible if...** - You have been diagnosed with another cancer within the past 3 years - You have received prior immunotherapy or fruquintinib - You have active autoimmune disease requiring systemic treatment - You are currently enrolled in another clinical study - You are pregnant or breastfeeding 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGImmunotherapy (Sintilimab)

Sintilimab

DRUGTargeted Therapy Agent (Fruquintinib)

Fruquintinib

RADIATIONRadiotherapy (SBRT and LDRT)

SBRT and LDRT


Locations(1)

Jinbo Yue

Jinan, Shandong, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06356584


Related Trials