Can a triple therapy shrink untreatable liver tumors?
NCT ID NCT07724951
First seen Jul 24, 2026 · Last updated Jul 28, 2026 · Updated 2 times
Summary
This study looks at whether combining the targeted drug donafenib with an immunotherapy drug and a liver-directed procedure (either chemoembolization or infusion chemotherapy) can help people with unresectable hepatocellular carcinoma — liver cancer that cannot be removed by surgery. Researchers will review medical records from about 400 patients treated at multiple hospitals to see how long the cancer stays under control and how safe the combination is. The goal is to find a better first-line treatment for this hard-to-treat cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- donafenib plus an anti-PD-1/L1 monoclonal antibody plus either transarterial chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC)
- What this could lead to
- If successful, this combination approach could offer a more effective first-line treatment option for people with unresectable liver cancer, potentially extending survival.
- What could go wrong
- This is a retrospective study, not a controlled trial, so results may be influenced by patient selection. The combination also carries risks of side effects from chemotherapy, immunotherapy, and liver-targeted procedures.
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.
- Participants
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About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2028
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.
Who is studied
Patients with unresectable hepatocellular carcinoma (uHCC) who received donafenib, PD-1/L1 monoclonal antibody combined with transarterial intervention therapy (TACE or HAIC) as first line treatment.
- Ages
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18 years and older
- 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: * Patients with unresectable hepatocellular carcinoma (uHCC) who received donafenib, an anti-PD-1/L1 monoclonal antibody combined with transarterial interventional therapy (TACE or HAIC), with retrievable records in the hospital electronic information system between June 1, 2021 and November 30, 2024. * Diagnosis of hepatocellular carcinoma confirmed by the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2024 Edition) clinically or by histology/cytology. * Age ≥18 years, regardless of sex. * No prior systemic therapy before the administration of donafenib, anti-PD-1/L1 monoclonal antibody combined with transarterial interventional therapy (TACE or HAIC). * The maximum interval between the initiation of donafenib, anti-PD-1/L1 monoclonal antibody, and transarterial interventional therapy (TACE or HAIC) does not exceed 8 weeks, and at the time the last of these treatment modalities is initiated, the subject must not have experienced disease progression. * For patients who have previously undergone hepatectomy, the resection must be R0, and tumor recurrence must have occurred more than 24 months after surgery. * At least one evaluable lesion (according to RECIST v1.1 criteria). * Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 to 1. * Child-Pugh class A or B. * Adequate major organ function, defined by the following criteria: Complete blood count (without blood transfusion or use of granulocyte colony-stimulating factor \[G-CSF\] within 14 days prior to screening): 1. Hemoglobin ≥90 g/L; 2. Absolute neutrophil count (ANC) ≥1.5×10⁹/L; 3. Platelet count ≥75×10⁹/L; \- Blood biochemistry (without albumin use within 14 days prior to screening): 4. Albumin ≥28 g/L; 5. Total bilirubin ≤2× upper limit of normal (ULN); 6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤5× ULN; 7. Alkaline phosphatase (ALP) ≤5× ULN; 8. Creatinine ≤1.5× ULN; \- Coagulation function: 9. International normalized ratio (INR) or prothrombin time (PT) ≤1.5× ULN; 10. Activated partial thromboplastin time (APTT) ≤1.5× ULN. Exclusion Criteria: * Incomplete or unavailable patient information data; patient refused follow-up or was lost to follow-up; * Duration of donafenib, PD-1/L1 monoclonal antibody combined with transarterial intervention therapy was less than 1 month; * Prior histologically/cytologically confirmed diagnosis of fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, or other components; * History of malignancy other than hepatocellular carcinoma, unless meeting the following criteria: a) The patient received potentially curative treatment and there has been no evidence of disease for 5 years; b) Successfully treated resected cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or other carcinoma in situ;
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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
8 sites. 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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Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
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Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
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The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
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The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
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Yunnan Cancer Hospital
Kunming, Yunan, China
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Zhong Shan Hospital Fudan University
Shanghai, Shanghai Municipality, China
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Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a smart drug starve liver tumors without harming healthy tissue?
- Liver size may hold key to immunotherapy response
- Can a new model forecast liver cancer in hepatitis b?
- Can radiation beads shrink untreatable liver tumors?
- Can an Anti-Inflammatory drug make liver cancer immunotherapy safer?