New hope for liver cancer patients: 4-drug combo targets untreatable tumors
NCT ID NCT07230314
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a powerful combination of treatments for people with liver cancer that cannot be surgically removed. It combines two local therapies (TACE and SBRT) with an immunotherapy drug and a targeted pill (donafenib) as the first treatment. The goal is to shrink tumors and control the disease. The study involves 34 adults aged 18-75 who have not had prior systemic therapy for their current cancer stage.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 34 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2025
An estimate. Start dates often move.
- Expected to finish
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Nov 2027
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.
- Ages
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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. Age range from 18 to 75 years old (including 18 and 75), with no gender restrictions; 2. Hepatocellular carcinoma diagnosed by histopathology, cytology or imaging; 3. Has not received any systemic anti-tumor therapy for the current stage of the disease in the past, including surgery (excluding stent placement), radiotherapy, chemotherapy, targeted therapy, immunotherapy, or investigational therapy; 4. CNLC staging Ib IIIa stage, cannot be surgically removed; 5. The maximum diameter of the tumor exceeds 5cm, and the number of tumors does not exceed 3 (1-3); 6. Can merge portal vein cancer thrombus; 7. Has not received any systemic anti-tumor therapy for the current stage of the disease in the past, including surgery (excluding stent placement), radiotherapy, chemotherapy, targeted therapy, immunotherapy, or investigational therapy; 8. Child Pugh score A5-B7; 9. ECOG (Eastern Cooperative Oncology Group) Physical Status Score: 0-1 points; 10. Expected survival period ≥ 3 months: 11. The main organ function is good, which meets the following criteria (no blood components, cell growth factors, white blood boosting drugs, platelet boosting drugs, or anemia correcting drugs are allowed to be used within 14 days before enrollment): Neutrophils ≥ 1.5 × 109/L; White blood cell count ≥ 3.0 × 109/L; Platelets ≥ 100 × 109/L; Hemoglobin ≥ 90g/L; Serum albumin ≥ 34g/L; Total bilirubin ≤ 1.5 × ULN (for patients with biliary obstruction receiving biliary drainage, it can be relaxed to\<2.5 × ULN); AST and ALT ≤ 2.5xULN (for patients with liver metastases, they can be relaxed to ≤ 5xULN); Creatinine clearance rate ≥ 60ml/min or blood creatinine ≤ 1.5 × ULN; INR ≤ 1.5 × ULN and APTT ≤ 1.5 × ULN (for stable dose anticoagulant therapy such as low molecular weight heparin or warfarin, and INR can be screened within the expected therapeutic range of anticoagulants); Electrocardiogram: QTc ≤ 450ms (male), ≤ 470ms (female); Cardiac ultrasound: LVEF (left ventricular ejection fraction) ≥ 50%; 8) Women of childbearing age must undergo a blood pregnancy test within 7 days before enrollment, and the result must be negative. They must also be willing to use appropriate contraception methods during the trial period and for 6 months after the end of treatment. For males, surgical sterilization should be performed, or they should agree to use appropriate contraception methods during the study period and within 3 months after the end of treatment; 9) Voluntarily participate in this study and sign an informed consent form; Good compliance, agree to cooperate and receive survival follow-up; Exclusion Criteria: 1. Received any of the following treatments: Previously received ICIs and/or HDACi treatment; Received the last anti-cancer treatment (including surgery, radiation therapy, etc.) within 4 weeks before enrollment; Received any other experimental drug/device treatment within 4 weeks prior to enrollment; Simultaneously enrolled in another clinical study, unless it is an observational (non interventional) clinical study or an interventional clinical study follow-up; 2. Known patients who are allergic to the components of the investigational drug; 3. Patients known to have central nervous system metastases; 4. Severe gastrointestinal dysfunction (with bleeding, severe inflammation, obstruction, or diarrhea greater than grade 2); 5. Serious infections (CTC AE\>grade 2) occurred within the first 4 weeks of enrollment, such as severe pneumonia, bacteremia, and infection complications that require hospitalization. Symptoms and signs of infection within the first 2 weeks of enrollment require intravenous antibiotic treatment (excluding prophylactic use of antibiotics); 6. Within the year prior to enrollment, there have been arterial/venous thrombotic events such as cerebrovascular accidents, deep vein thrombosis, and pulmonary embolism; 7. Clinical symptoms or diseases of the heart that have not been well controlled, such as: (1) NYHA grade 2 or above heart failure; (2) Unstable angina pectoris; (3) Have experienced myocardial infarction within one year; (4) Patients with clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention. 8. Patients with malignant tumors other than liver cancer prior to the first use of the investigational drug are excluded, except for malignant tumors with low-risk metastasis and mortality risk (5-year survival rate\>90%), such as fully treated cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma; 9. Merge active hepatitis B (HBV DNA ≥ 2000IU/mL or 104 copies/mL) and hepatitis C (positive for hepatitis C antibodies); 10. People who are known to have acquired immunodeficiency syndrome (AIDS) or HIV test positive, active syphilis infection; 11. Having a clear history of neurological or mental disorders, including epilepsy or dementia: 12. Planned pregnancy, pregnant and lactating women; According to the researchers' assessment, there may be other factors that could force the subjects to terminate the study midway, such as non-compliance with the protocol, having other serious illnesses (including mental illnesses) that require concomitant treatment, severe abnormal laboratory test values, family or social factors that may affect the safety of the subjects or the collection of trial data, etc;
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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 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.
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Other studies related to the condition(s) this trial covers.
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