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AzTrials

Unresectable Hepatocellular CarcinomaPhase 2NCT07230314

Sequential Transarterial Chemoembolization (TACE), Stereotactic Body Radiation Therapy (SBRT), and Immune Checkpoint Inhibitors for Unresectable Hepatocellular Carcinoma Treated With Donafenib

A Phase 2 study testing Donafina and PD-1/PD-L1 inhibitor in people with Unresectable Hepatocellular Carcinoma, run by Jinling Hospital, China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This study is a single arm, single center, open label clinical trial. Recruit 34 subjects who meet the inclusion criteria and receive hepatic artery chemoembolization (TACE) and stereotactic body radiotherapy (SBRT) combined with immune checkpoint inhibitors and donafenib treatment according to the study plan. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Unresectable Hepatocellular Carcinoma
What is being tested?
Donafina and PD-1/PD-L1 inhibitor
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
No sites listed yet
Study dates
30 Nov 2025to 30 Nov 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age range from 18 to 75 years old (including 18 and 75), with no gender restrictions;
  • Hepatocellular carcinoma diagnosed by histopathology, cytology or imaging;
  • 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;
  • CNLC staging Ib IIIa stage, cannot be surgically removed;
  • The maximum diameter of the tumor exceeds 5cm, and the number of tumors does not exceed 3 (1-3);
  • Can merge portal vein cancer thrombus;
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  • 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;
  • Child Pugh score A5-B7;
  • ECOG (Eastern Cooperative Oncology Group) Physical Status Score: 0-1 points;
  • Expected survival period ≥ 3 months:
  • 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;

Who cannot join

  • 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;
  • Known patients who are allergic to the components of the investigational drug;
  • Patients known to have central nervous system metastases;
  • Severe gastrointestinal dysfunction (with bleeding, severe inflammation, obstruction, or diarrhea greater than grade 2);
  • 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);
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  • Within the year prior to enrollment, there have been arterial/venous thrombotic events such as cerebrovascular accidents, deep vein thrombosis, and pulmonary embolism;
  • 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.
  • 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;
  • Merge active hepatitis B (HBV DNA ≥ 2000IU/mL or 104 copies/mL) and hepatitis C (positive for hepatitis C antibodies);
  • People who are known to have acquired immunodeficiency syndrome (AIDS) or HIV test positive, active syphilis infection;
  • Having a clear history of neurological or mental disorders, including epilepsy or dementia:
  • 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;

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Liu Xiufeng contact

+8613357837170

liuxiufeng@csco.org.cn

About this study

Official title: Luminate Study: A Single-arm, Single-center, Open-label Clinical Study of Transarterial Chemoembolization (TACE) Plus Stereotactic Body Radiotherapy (SBRT) Combined With PD-1/L1 Inhibitor and Donafenib as First-line Therapy for Unresectable Hepatocellular Carcinoma.

This study is a single arm, single center, open label clinical trial. Recruit 34 subjects who meet the inclusion criteria and receive hepatic artery chemoembolization (TACE) and stereotactic body radiotherapy (SBRT) combined with immune checkpoint inhibitors and donafenib treatment according to the study plan. The treatment cycle and dosage can be adjusted according to the patient's tolerance. Until disease progression or intolerable toxic reactions occur. Observe the effectiveness and safety indicators during the experimental process.

Read the detailed description

This study is a single arm, single center, open label clinical trial. Recruit 34 subjects who meet the inclusion criteria and receive hepatic artery chemoembolization (TACE) and stereotactic body radiotherapy (SBRT) combined with immune checkpoint inhibitors and donafenib treatment according to the study plan. The treatment cycle and dosage can be adjusted according to the patient's tolerance. Until disease progression or intolerable toxic reactions occur. Observe the effectiveness and safety indicators during the experimental process.

Efficacy evaluation: The first efficacy evaluation is conducted 6 weeks (± 7 days) after the first administration, and every 6 weeks (± 7 days) thereafter. Imaging examinations include: CT or MRI of the brain, chest, abdomen (including pelvic cavity) (all are enhanced, unless contrast agents are contraindicated, plain scan can be used as a substitute).

Safety evaluation: Conducted on a weekly basis, objective indicators are obtained through examination, and subjective indicators are obtained through adverse events reported by patients.

Being tested
Donafina, PD-1/PD-L1 inhibitor
Keywords
transarterial chemoembolization (TACE), stereotactic body radiotherapy (SBRT), PD-1/L1 inhibitor, donafenib, first-line therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DonafinaDrug

    During the treatment, oral administration of Donafenib (0.2g, bid) was consistently administered

  • PD-1/PD-L1 inhibitorDrug

    According to the specific drug instructions, Q3W， The maximum usage time is 2 years

Study groups in NCT07230314
Study groupRoleWhat they receive
TACE and SBRT combined with immune checkpoint inhibitors and treatment with donafenibExperimentalNot described
Receives: Drug: Donafina; Drug: PD-1/PD-L1 inhibitor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate, ORR

    Measured: If the therapeutic effect reaches CR or PR, the subject must confirm it no less than 4 weeks ± 7 days after the initial evaluation.

Secondary outcomes (2)

  1. Overall survival, OS

    Measured: every 3 months after the patient completed the trial treatment

  2. disease control rate

    Measured: If the therapeutic effect reaches CR or PR, the subject must confirm it no less than 4 weeks ± 7 days after the initial evaluation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2025
  2. Study start30 Nov 2025 (estimated)
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion30 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07230314
Sponsor's protocol ID
CSIIT-Q81
Status last verified
Nov 2025
First submitted
29 Sep 2025
Last updated
17 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Donafina and PD-1/PD-L1 inhibitor in people with Unresectable Hepatocellular Carcinoma, run by Jinling Hospital, China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Liu Xiufeng (+8613357837170, liuxiufeng@csco.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate, ORR (time frame: If the therapeutic effect reaches CR or PR, the subject must confirm it no less than 4 weeks ± 7 days after the initial evaluation.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07230314.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.

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