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New combo therapy targets hard-to-treat liver metastases in colorectal cancer

NCT ID NCT06199232

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jul 29, 2026 · Updated 3 times

Summary

This trial tests a personalized treatment plan for people with advanced colorectal cancer that has spread to the liver and stopped responding to standard treatments. The approach combines a liver-directed chemotherapy (HAIC), a targeted therapy (fruquintinib or cetuximab), and an immunotherapy drug (tislelizumab). The study aims to see if this combination can help control the cancer for at least 6 months. It includes 47 participants whose tumors are microsatellite stable (MSS), a type that typically does not respond well to immunotherapy alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tislelizumab (immunotherapy) plus fruquintinib or cetuximab (targeted therapy) plus hepatic arterial infusion chemotherapy (HAIC)
What this could lead to
If successful, this could offer a new treatment option for people with advanced colorectal cancer that has spread to the liver and stopped responding to standard therapies.
What could go wrong
This is a small, early-phase trial with only 47 participants, so results may not apply to everyone. The combination therapy also carries risks of side effects from chemotherapy, targeted drugs, and immunotherapy.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

47 people

The number who actually took part.

Started

Jan 2024

Finished

Jul 2026

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 80 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. 18-80 years old. 2. Colorectal cancer confirmed by histopatology. 3. The metastasis is mainly located in liver. 4. Unresectable liver metastasis is confirmed by CT/MRI scan and multidisciplinary. 5. Failed from standard first- and second-line systemic treatment. 6. At least one measurable lesion according to modified Response Evaluation Criteria in Solid Tumors guidelines (mRECIST). 7. Eastern Cooperative Oncology Group (ECOG) performance status \<2. 8. Child-Pugh A or B (≤ 7). 9. Expectant survival time ≥ 3 months. 10. Adequate organ function as follows: 1. Hemoglobin ≥ 90 g/L; 2. Absolute neutrophil count ≥ 1.5×10\^9/L; 3. Blood platelet count ≥ 775×10\^9/L; 4. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 5 times of upper limit of normal (ULN); 5. Total bilirubin ≤ 2 times of ULN; 6. Serum creatinine ≤ 1.5 times of ULN; 7. Albumin ≥ 30 g/L. 11. Patients sign informed consent. Exclusion Criteria: 1. Extensive extrahepatic metastasis (\>25% of tumor burden in liver). 2. HER2 (3+) or HER2 amplification. 3. MSI-H or dMMR. 4. Allergic to contrast media. 5. Pregnant or lactational. 6. Allergic to oxaliplatin or cetuximab. 7. Coinstantaneous a lot of malignant hydrothorax or ascites. 8. History of organ transplantation (including bone marrow auto-transplantation and peripheral stem cell transplantation). 9. Coinstantaneous infection and need anti-infection therapy. 10. Coinstantaneous peripheral nervous system disorder. 11. History of obvious mental disorder and central nervous system disorder. 12. Concomitant malignancy within 5 years, except for non-melanoma skin cancer and carcinoma in situ of cervix. 13. Without legal capacity. 14. Impact the study because of medical or ethical reasons. 15. Clinically severe gastrointestinal bleeding within 6 months of the start of treatment or any life-threatening bleeding events within 3 months of the start of treatment. 16. Uncorrectable coagulation disorder. 17. Obvious abnormal in ECG or obvious clinical symptoms of heart disease, like congestive heart failure, coronary heart disease with obvious clinical symptoms, unmanageable arrhythmia and hypertension. 18. History of myocardial infarction within 12 months, or Grade III/IV of heart function. 19. Severe liver disease (like cirrhosis), renal disease, respiratory disease, unmanageable diabetes or other kinds of systematic disease. 20. Any other subjects that the investigator considers ineligible.

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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.

Contacts and locations

Locations

  • Peking Univerisity Cancer Hospital

    Beijing, Beijing Municipality, 100142, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.