Can a triple therapy shrink untreatable liver tumors?

NCT ID NCT07724951

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jul 2028

An estimate. End dates often move.

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.

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

18 years and older

Sex

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

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.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, China

  • Sun Yat-sen Memorial Hospital

    Guangzhou, Guangdong, China

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, China

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, China

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, China

  • Yunnan Cancer Hospital

    Kunming, Yunan, China

  • Zhong Shan Hospital Fudan University

    Shanghai, Shanghai Municipality, China

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, China

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