Liver cancer combo trial halted early – only 18 patients enrolled
NCT ID NCT05171166
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether adding a stronger chemotherapy infusion (HAIC-TACE) to the targeted drug donafenib works better than standard treatment for people with intermediate-stage liver cancer that cannot be removed by surgery. The trial was stopped early and only included 18 participants, so the results are not reliable enough to draw firm conclusions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Donafenib (a targeted cancer drug) and chemotherapy (oxaliplatin, 5-fluorouracil, leucovorin calcium) given via liver artery infusion
- What this could lead to
- If successful, this combination could offer a new treatment option for people with intermediate-stage liver cancer that cannot be surgically removed.
- What could go wrong
- The trial was terminated early and enrolled only 18 people, so results are very preliminary. The combination may not improve survival and could cause serious side effects from chemotherapy and targeted therapy.
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 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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18 people
The number who actually took part.
- Started
-
Dec 2021
- Finished
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Oct 2025
- 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 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: 1. Subjects must volunteer to participate in the study, signed informed consent, and were able to comply with the program requirements of visits and related procedures. 2. Age and gender: \>18 years old and≤75 years old, both men and women. 3. All subjects must have Hepatocellular Carcinoma confirmed by pathological or clinical diagnosis. 4. Subjects are not suitable for radical resection or radical ablative therapy. 5. BCLC B based on Barcelona Clinic Liver Cancer staging system, and the lesions in the liver exceed up to 7 criteria, the number of tumors + the maximum diameter of tumors \> 7. 6. Patients with viable and measurable target lesion per mRECIST. 7. Patients who are expected to live more than 3 months. 8. ECOG PS 0-1. 9. Child-Pugh class A. 10. Patients with laboratory values that meet the following criteria: 1. Hemoglobin≥90 g/L; 2. Neutrophile granulocytes≥1.5×109/L; 3. Platelet count≥75×109/L; 4. Albumin≥30 g/L; 5. Total serum bilirubin ≤ 2 times upper limits of normal; 6. AST and ALT ≤ 5 times upper limits of normal; 7. Serum creatinine ≤ 1.5 times upper limits of normal; 8. Alkaline phosphatase ≤ 5 times upper limits of normal; 9. Prothrombin time or international normalized ratio ≤ 1.5 times upper limits of normal, activated partial thromboplastin time (APTT) ≤ 1.5×ULN; Exclusion Criteria: 1. Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma confirmed by histology or cytology. 2. History of malignant tumor, excluding the following cases: 1. Malignant tumor that was curatively treated more than 5 years prior to study entry and has not recurred since then; 2. Successful radical resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder carcinoma, preinvasive cervix carcinoma, and other preinvasive cancers. 3. Diffuse tumor lesion. 4. The lesions load in the liver exceeds 20, the number of tumors + the maximum diameter of tumors \> 20. 5. Vascular invasion or extrahepatic metastasis. 6. Preexisting or history of hepatic encephalopathy, hepatorenal syndrome or liver transplantation. 7. Clinically uncontrolled ascites or pleural effusion. 8. History of surgical excision or ablation within 4 weeks of the start of treatment. 9. History of hepatic arterial infusion, more than twice TACE therapy, or history of TACE within 6 months of the start of treatment. 10. History of systemic therapy, including but not limited to chemotherapy, targeted therapy, immunotherapy. 11. History of thrombosis and/or embolism within 6 months of the start of treatment. 12. 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. 13. Clinically significant cardiovascular disease, including, but not limited to, acute myocardial infarction, severe/unstable angina or prior coronary artery bypass surgery, congestive heart failure (NYHA \>2), poorly controlled arrhythmias or arrhythmias requiring pacemaker therapy, hypertension not controlled by medication (systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg) within the past 6 months. 14. Other significant clinical and laboratory abnormalities, such as uncontrolled diabetes, chronic kidney disease, grade II or above peripheral neuropathy (CTCAE V5.0), and thyroid dysfunction, that may affect the safety evaluation. 15. Severe infections that are active or clinically poorly controlled. 16. If accompanied by acute or chronic active hepatitis B, unless taking antiviral drugs. 17. Female patients who are pregnant, lactating, possibly pregnant, or planning to become pregnant, and fertile female or male patient who is unwilling or unable to use effective contraception. 18. Multiple branches of hepatic artery with severe variation. 19. 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 University Cancer Hospital
Beijing, Beijing Municipality, 100142, China
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Other studies related to the condition(s) this trial covers.
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