Immunotherapy combo aims to turn inoperable liver tumors into operable ones
NCT ID NCT07815288
First seen Sep 11, 2026 · Last updated Sep 11, 2026
Summary
Researchers test whether adding retlirafusp alfa, an experimental immunotherapy, to standard targeted drugs and chemotherapy can shrink colorectal cancer that has spread to the liver enough to allow surgery. The trial enrolls about 80 adults with initially unresectable liver metastases from colorectal adenocarcinoma. Participants receive one of two drug combinations based on their tumor's genetic profile, and doctors track how many tumors respond and how many become removable.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- retlirafusp alfa, an experimental immunotherapy that blocks two cancer-promoting signals (PD-L1 and TGF-beta), given with standard targeted drugs and chemotherapy
- What this could lead to
- If it works, this approach could make surgery possible for some people whose colorectal cancer has spread to the liver and cannot be removed at diagnosis.
- What could go wrong
- This is a small, early-stage trial at one center, so results may not hold up in larger studies. Combining immunotherapy with chemotherapy and targeted drugs can cause serious side effects, and the treatment may not shrink tumors enough for surgery.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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 80 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
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 79 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: 1. Signed written informed consent before any trial-related procedure. 2. Age ≥18 and ≤79 years, male or female. 3. Histopathologically confirmed colorectal adenocarcinoma; liver metastasis confirmed by pathology or imaging. 4. No prior first-line systemic therapy (targeted, immunotherapy, systemic chemotherapy) specifically for liver metastases. 5. At least 1 measurable lesion per RECIST 1.1. 6. Multidisciplinary-team-confirmed initially unresectable colorectal liver metastases (cannot achieve R0/R1 resection; or predicted future remnant liver volume \< 30 %; or insufficient hepatic inflow/outflow). Patients with extra-hepatic metastases (excluding brain / bone metastases) amenable to local therapy are eligible. 7. Microsatellite-stable (MSS) / mismatch-repair-proficient (pMMR) confirmed by IHC or PCR. 8. ECOG Performance Status 0-1. 9. Expected survival ≥12 weeks. 10. No urgent-surgery indications (e.g., primary-tumor bleeding, obstruction). 11. Adequate organ function within 14 days prior to first study-drug: * ANC ≥1.5 × 10⁹/L; Platelets ≥75 × 10⁹/L; Hb \> 70 g/L * Total bilirubin ≤1.5 × ULN; Albumin ≥28.0 g/L * AST / ALT ≤5 × ULN * Creatinine ≤1.5 × ULN; Cockcroft-Gault creatinine clearance ≥60 mL/min * INR / PT ≤1.5 × ULN 12. Females of reproductive potential / males with reproductive-potential partners agree to highly-effective contraception starting 7 days prior first dose until 24 weeks after last dose. 13. Serum pregnancy test negative within 7 days before first dose (women of child-bearing potential). 14. Willing and able to comply with all trial visits, treatment and assessments.- Exclusion Criteria: * 1\. Inability to tolerate systemic chemotherapy or subsequent surgery. 2. Liver metastases occurring during or within 6 months after completion of oxaliplatin-based adjuvant chemotherapy for primary colorectal tumor. 3\. Major surgery within 6 weeks before study entry; severe trauma / non-healing wounds / fractures. 4\. Myocardial infarction, unstable angina, coronary-artery-bypass-graft within prior 3 months; NYHA class III-IV heart failure. 5\. Prior treatment with immune-checkpoint-inhibitors (anti-PD-1/PD-L1, anti-CTLA-4 etc.). 6\. Concurrent or prior other malignancy whose expected survival is shorter than colorectal-liver-metastasis prognosis. 7\. History of allogeneic hematopoietic-stem-cell or solid-organ transplant (except corneal transplant). 8\. History of moderate-severe hypersensitivity / anaphylaxis to antibody-based therapeutics. 9\. Clinically-significant bleeding diathesis or major bleeding episode within prior 3 months (e.g., gastrointestinal bleeding, esophageal varices, hematemesis, hemoptysis). 10\. Symptomatic large-volume ascites / pleural effusion / pericardial effusion requiring intervention. 11\. Primary-tumor perforation, abdominal infection occurring within prior 3 months without adequate management. 12\. Known hypersensitivity to active ingredients or excipients of study drugs. 13. Active peptic ulcer, gastrointestinal obstruction, active GI bleeding, perforation, malabsorption, uncontrolled inflammatory bowel disease. 14\. Pregnant or lactating women. 15. Concurrent participation in another interventional clinical trial. 16. Any other condition judged by investigator to make subject unsuitable for trial participation.
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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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Peking University Cancer Hospital & Institute
Beijing, Beijing Municipality, 100142, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can targeted liver chemo turn inoperable tumors into operable ones?
- New blood test could spot colon cancer before it spreads
- New classification system may help guide treatment for colorectal cancer spread to liver
- Liver-Focused chemo after surgery aims to stop cancer return
- New drug combo aims to shrink liver tumors in colorectal cancer patients
- Electric pulses zapping liver tumors: new hope for colorectal cancer patients?