Immunotherapy combo aims to turn inoperable liver tumors into operable ones

NCT ID NCT07815288

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

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

18 to 79 years

Sex

Anyone

Healthy volunteers

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

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

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • Peking University Cancer Hospital & Institute

    Beijing, Beijing Municipality, 100142, China

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