New combo therapy aims to stop liver cancer from coming back
NCT ID NCT04962958
First seen Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time
Summary
This study tests whether adding a targeted drug (Donafenib) and chemotherapy directly into the liver's blood supply can prevent liver cancer from returning after surgery. It includes adults with a single large tumor (≥5 cm) and microscopic blood vessel invasion, who are at high risk of recurrence. Participants receive the combined treatment for up to 2 years, and researchers track how many remain cancer-free during that time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Donafenib, oxaliplatin, fluorouracil, leucovorin
- What this could lead to
- If successful, this approach could offer a new way to delay or prevent liver cancer from returning after surgery in patients at high risk.
- What could go wrong
- This is a small, early-phase study with no comparison group, so results may not be definitive. The combination therapy also carries risks of side effects from chemotherapy and targeted drugs.
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
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
30 people
The number who actually took part.
- Started
-
Dec 2021
- Finished
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Sep 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
-
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. Aged 18-75 years, male or female; 2. Naive patients with hepatocellular carcinoma pathologically diagnosed who have Underwent radical hepatectomy 4-8 weeks before enrollment; 3. HCC patients with a solitary tumor≥5 cm and Microvascular invasion; 4. Child-Pugh score A/B(≤7); 5. ECOG PS score 0-1; 6. No residual tumor lesions were confirmed on imaging more than 4 weeks after surgery; 7. The main organ functions meet the following criteria within 14 days before enrollment; (1)Hemoglobin(HB)≥100 g/L (2)neutrophils(ANC)≥1.5×10\^9 /L, (3)platelet count(PLT)≥75×10\^9/L; (4)ALB≥28g/L (5)alanine aminotransferase(ALT), aspartate aminotransferase(AST)\<5×ULN (6)Total bilirubin (TBIL)\<1.5×ULN (7)Plasma creatinine ≤1.5×ULN with a creatinine clearance≥50mL/min (8)Activation Partial Thrombin Activation Time (APTT) and International Normalized Ratio (INR)≤1.5×ULN 8. Subjects voluntarily enrolled in the study, signed an informed consent form, followed well and cooperated with the follow-up Exclusion Criteria: 1. Patients who have received any hepatocellular carcinoma-related systemic therapy before enrollment; including targeted therapy such as sorafenib, lenvatinib, and regorafenib, or immunomodulators such as anti-PD-1, anti-PD-L1, and anti-CTLA-4 Treatment, excluding antiviral treatment; if the patient has used traditional Chinese medicine with anti-tumor indications, it must be\> 2 weeks or 5 drug half-lives (whichever is longer). Patients whose adverse events caused by treatment have not recovered to ≤ CTCAE Grade 1; 2. Patients who have received other adjuvant treatments (except antiviral therapy) after radical hepatectomy, including adjuvant local treatments (such as transarterial chemoembolization \[TACE\]); 3. Hepatic veins, portal veins, bile ducts, or inferior vena cava can be visually or microscopically seen with tumor thrombi 4. Diagnosed with lymph node invasion or extrahepatic metastasis; 5. Number of tumors≥2; 6. A history of other malignant tumours within the last five years, except for cured skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ or other carcinoma in situ; 7. Pregnant or breastfeeding women; males or females of childbearing age who are unwilling or unable to take effective contraceptive measures 8. Known history of alcohol, psychotropic drug or other drug abuse within 6 months before entry into the study 9.Those the researcher deems inappropriate for inclusion.
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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
-
Lei Zhang
Guangzhou, Guangdong, 51000, China
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Other studies related to the condition(s) this trial covers.
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