Combining Fruquintinib, Regorafenib, and Sintilimab with Radiotherapy for Advanced Colorectal Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of a combination therapy involving Fruquintinib, Regorafenib, and Sintilimab, with or without radiotherapy, for patients with metastatic colorectal cancer who have already undergone first- and second-line treatments. The study aims to assess progression-free survival, overall survival, and treatment response rates in patients with both non-liver and liver metastases. Participants will receive tailored treatment protocols based on their specific cancer characteristics, and subgroup analyses will focus on the impact of liver metastases on treatment outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* ECOG PS 0-2
* Histologically confirmed colorectal adenocarcinoma with liver metastases (8th edition AJCC)
* MSS/pMMR subtype
* Previously received standard first- and second-line systemic anti-tumor therapy
* At least one measurable lesion as defined by RECIST 1.1 criteria
* Access to tumor samples for biomarker assessment
* Expected survival of ≥3 months
* Normal function of major organ systems (within 14 days before enrollment)
* No systemic corticosteroid treatment within 7 days before treatment initiation, excluding physiological corticosteroid replacement therapy.
* Fertile males or females with the potential for pregnancy must use highly effective contraception methods during the trial.

Exclusion Criteria:

* Patients diagnosed with malignancies other than colorectal cancer within 3 years prior to enrollment.
* Participating in an interventional clinical study or receiving other investigational drugs or treatments with study devices within the past 4 weeks before enrollment.
* Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs targeting another T cell co-stimulatory or co-inhibitory receptor (e.g., CTLA-4, OX-40, CD137), fruquintinib, etc.
* Received traditional Chinese medicine or immune-modulating drugs with anti-tumor indications within the past 2 weeks before enrollment (excluding local use for controlling pleural effusion).
* Experienced active autoimmune diseases requiring systemic therapy within the past 2 years before enrollment. Replacement therapy is not considered systemic therapy.
* Diagnosed with immune deficiency or received systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of investigational treatment. After consultation with the sponsor, the use of physiological doses of corticosteroids may be approved.
* Received liver radiotherapy within the past 2 weeks before enrollment.
* Known presence of central nervous system metastases and/or carcinomatous meningitis.
* Received systemic corticosteroid therapy within 7 days before enrollment.

Where it's running

• Jinbo Yue
  Jinan, Shandong, China Recruiting

Study contacts

• Principal investigator: Jin Bo Yue — Shandong Cancer Hospital and Institute
• Study coordinator: Jin Bo Yue, dorctor
• Email: Len.Xu@hotmail.com
• Phone: 0531-67626442

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.