New combo therapy aims to shrink liver tumors in hard-to-treat colorectal cancer
NCT ID NCT06356584
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding radiotherapy to a drug combination (fruquintinib and sintilimab) can help control colorectal cancer that has spread to the liver and hasn't responded to two prior treatments. About 62 adults with a specific type of colorectal cancer (MSS/pMMR) will be randomly assigned to receive the drug combo with or without radiotherapy. The goal is to see if the triple therapy improves how long the cancer stays under control and overall survival.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 62 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2024
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Jinbo Yue
RECRUITINGJinan, Shandong, 250000, China
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