New combo therapy targets hard-to-treat liver metastases in colorectal cancer
NCT ID NCT06199232
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
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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
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47 people
The number who actually took part.
- Started
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Jan 2024
- Finished
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Jul 2026
- 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 80 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. 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
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Peking Univerisity Cancer Hospital
Beijing, Beijing Municipality, 100142, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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