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Unresectable Hepatocellular CarcinomaPhase 2NCT05507632

Donafenib Plus Sintilimab in Combination With TACE in Patients With Unresectable Hepatocellular Carcinoma

A Phase 2 study testing Donafenib plus Sintilimab in combination with transarterial chemoembolisation in people with Unresectable Hepatocellular Carcinoma, run by Nanfang Hospital, Southern Medical University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

To evaluate the efficacy and safety of Donafenib plus Sintilimab in combination with transarterial chemoembolisation (TACE) in patients with unresectable hepatocellular carcinoma(HCC). 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?
Donafenib plus Sintilimab in combination with transarterial chemoembolisation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteChina
Study dates
18 Aug 2022to 21 Dec 2026
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

  • The patient voluntarily joins the study and signs an informed consent;
  • Aged 18 to 75 years, both men and women;
  • Clinically or pathologically confirmed Barcelona Clinic Liver Cancer (BCLC) stage B or C HCC, not suitable for radical treatment, and no prior systemic therapy for liver cancer;
  • At least one measurable lesion according to mRECIST, defined as a spiral computed tomography (CT) long diameter ≥10 mm or lymph node short diameter ≥15 mm;
  • Child-Pugh score small or equal to 7 points (Child-Pugh A-B);
  • Single lesion <10 cm in greatest dimension and tumor burden <50% of liver volume;
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  • Must be able to swallow tablets;
  • ECOG score: 0 to 1 (according to the ECOG score classification);
  • The expected survival is longer than 12 weeks;
  • The laboratory parameters meets the following requirements: Absolute neutrophil count >= 1.5 x 10^9 / L; Platelets >= 50 x 10^9 / L; Hemoglobin >= 80 g / L; serum albumin >= 28 g / L; Thyroid stimulating hormone (TSH) <= 1 x ULN (if abnormalities should be considered at the same time FT3, FT4 levels, patients with FT3 and FT4 levels in normal range can also be enrolled); bilirubin <= 1.5 x ULN (within 7 days prior to the first dose); ALT <= 5 x ULN and AST <= 5 x ULN (within 7 days prior to the first dose); AKP <= 2.5 x ULN; serum creatinine <= 1.5 x ULN;
  • For female that non-surgical sterilization or in childbearing age need to use a medically approved contraceptive (such as an intrauterine device, contraceptive or condom) during the study period and within 3 months after the end of the study treatment period; For female that non-surgical sterilization or in childbearing age must have a negative serum or urine HCG test within 72 hours prior to study enrollment; and must be non-lactating; for male patients whose partner in a childbearing age, effective methods of contraception should be given during the trial and at the end of Sintilimab injection.

Who cannot join

  • Any tumor ≥ 10 cm in greatest dimension or tumor involvement ≥ 50% of the liver volume;
  • Receive local treatment for HCC((e.g.,TACE, TAE, HAIC or radiotherapy); Ablation and resection are permitted if performed >4 weeks before the first dose of study intervention;
  • The patient has any active auto-immune disease or a history of auto-radioimmune disease;
  • Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy;
  • The patient is using immunosuppressive agents or systemic hormonal therapy for immunosuppression purposes (dose > 10 mg/day of prednisone or other therapeutic hormones) and continues to be used within 2 weeks prior to enrollment;
  • Known or suspected allergy to the investigational agents or any agent given in association with this trial;
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  • Known central nervous system tumors including metastatic brain disease;
  • History of organ allograft;
  • Ascites with clinical symptoms;
  • The intrahepatic neoplasms showed diffuse changes;
  • Suffering from hypertension, and cannot be well controlled by antihypertensive drugs (systolic blood pressure >= 140mmHg or diastolic blood pressure >=90 mmHg);
  • Suffering heart diseases with clinical symptoms or those not well controlled, such as:(1) Heart failure in NYHA class 2 or higher;(2) Unstable angina;(3) Myocardial infarction occurred within 1 year;(4) Clinically symptomatic supraventricular or ventricular arrhythmia requiring treatment or intervention;(5) Tc > 450ms (male); QTc > 470ms (female).
  • Abnormal coagulation (INR>2.0, PT extension time >4s), bleeding tendency or being treated with thrombolytic or anticoagulant therapy, allowing prophylactic use of low-dose aspirin and low-molecular-weight heparin;
  • Evidence of bleeding diathesis; Patients with clinically significant gastrointestinal bleeding within 3 months prior to study entry.
  • Events of arterial/venous thrombosis occurring within the first 6 months of enrollment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;
  • Known history of hereditary or acquired bleeding and thrombotic tendencies (e.g., hemophiliacs, coagulopathy, thrombocytopenia, etc.);
  • Had intestinal obstruction and/or had clinical signs or symptoms of GI obstruction within 6 months prior to the start of study treatment, including incomplete obstruction related to pre-existing conditions or requiring routine parenteral hydration, parenteral nutrition, or tube feeding;
  • Urine routine indicates that urine protein >= ++ and 24-hour urine protein amount > 1.0g was confirmed;
  • The patient has active infection, unexplained fever (>=38.5 degree C) within 3 days before administration, or baseline white blood cell count > 15 x 10^9/L;
  • Patients with congenital or acquired immunodeficiency (such as HIV-infected patients); Concurrent hepatitis B virus (HBV) and hepatitis C virus (HCV) coinfection without initiation of antiviral therapy. Subjects who initiated anti-HBV and anti-HCV treatment prior to enrollment are eligible;
  • The patient has had other malignant tumors in the past 3 years or at the same time (except for cured skin basal cell carcinoma and cervical carcinoma in situ);
  • Palliative radiotherapy for non-target lesions to control symptoms is permitted and must be completed at least 2 weeks prior to the start of the study treatment. The adverse events caused by radiotherapy have not recovered to <= CTCAE 1;
  • Patients have previously received other anti-PD-1 antibody therapy or other immunotherapy against PD-1/PD-L1, or have received targeted therapies (e.g., sorafenib, lenvatinib) before;
  • Inoculation of a live vaccine within less than 4 weeks prior to study or possibly during the study period;
  • Pregnant or lactating women, or women of childbearing age who are unwilling to take contraceptive measures;
  • According to the investigators, the patient has other factors that may affect the results of the study or lead to the termination of the study, such as alcohol abuse, drug abuse, other serious diseases (including mental illness) requiring combined treatment, and serious laboratory tests, abnormalities, accompanied by factors such as family or society, which may affect the safety of enrolled patients.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong

Other trials in China

About this study

Official title: A Prospective, Single-arm, Phase II Clinical Study of the Efficacy and Safety of Donafenib Plus Sintilimab Combined With Transarterial Chemoembolization (TACE) in Patients With BCLC Stage B/C Hepatocellular Carcinoma

To evaluate the efficacy and safety of Donafenib plus Sintilimab in combination with transarterial chemoembolisation (TACE) in patients with unresectable hepatocellular carcinoma(HCC).

Read the detailed description

Transarterial chemoembolisation (TACE) was effective and safe for hepatocellular carcinoma. Donafenib was better than sorafenib in overall survival in untreated advanced hepatocellular carcinoma, and programmed cell death protein-1 (PD-1) antibody was effective and tolerable in patients with advanced hepatocellular carcinoma. No study has evaluated TACE plus donafenib and sintilimab. Thus, the investigators carried out this prospective, single-arm study to find out it.

Being tested
Donafenib plus Sintilimab in combination with transarterial chemoembolisation
Keywords
hepatocellular carcinoma, HCC, Donafenib, Sintilimab, transarterial chemoembolisation
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • Donafenib plus Sintilimab in combination with transarterial chemoembolisationCombination product

    Donafenib plus Sintilimab in combination with transarterial chemoembolisation (TACE)

Study groups in NCT05507632
Study groupRoleWhat they receive
single-armExperimentalAll patients treatment with Donafenib plus Sintilimab in combination with TACE
Receives: Combination Product: Donafenib plus Sintilimab in combination with transarterial chemoembolisation

What is being measured

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

  1. Objective response rate (ORR) as assessed by mRECIST

    ORR is defined as the percentage of participants who have best overall response (BOR) of complete response (CR) or partial response (PR) at the time of data cutoff as assessed by mRECIST

    Measured: From date of first dose of study treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination (up to approximately 3 years)

Secondary outcomes (5)

  1. Objective response rate (ORR) as assessed by RECIST 1.1

    ORR is defined as the percentage of participants who have best overall response (BOR) of complete response (CR) or partial response (PR) at the time of data cutoff as assessed by RECIST 1.1

    Measured: From date of first dose of study treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination (up to approximately 3 years)

  2. Disease control rate (DCR)

    DCR is defined as the percentage of participants who have best overall response (BOR) of complete response (CR) or partial response (PR) or stable disease (SD) at the time of data cutoff as assessed both by mRECIST and RECIST 1.1

    Measured: From date of first dose of study treatment until disease progression, stable disease, development of unacceptable toxicity, withdrawal of consent, or sponsor termination (up to approximately 3 years)

  3. Duration of response (DOR)

    DOR is defined as the time from the first documentation of CR or PR to the date of first documentation of disease progression or death (whichever occurs first) as assessed both by mRECIST and RECIST 1.1

    Measured: From the first documentation of CR or PR to the first date of documentation of disease progression or death whichever occurs first (up to approximately 3 years)

  4. Progression-free survival (PFS)

    The progression free survival time defined as the time from the first study treatment date to the date of first documentation of disease progression or death (which occured first) as assessed both by mRECIST and RECIST 1.1

    Measured: From date of first dose of study treatment to the date of first documentation of disease progression or death, whichever occurs first (up to approximately 3 years)

  5. Overall survival (OS)

    Overall survival is measured from the start date of the Treatment Phase (date of first study treatment) until date of death from any cause. Participants who are lost to follow-up and the participants who are alive at the date of data cutoff will be censored at the date the participant was last known alive or the cut-off date, whichever comes early.

    Measured: From date of first dose of study treatment to the date of first documentation of disease progression or death, whichever occurs first (up to approximately 3 years)

Timeline

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

  1. First posted19 Aug 2022
  2. Study start18 Aug 2022
  3. Primary completion26 Mar 2026
  4. Study completion21 Dec 2026 (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
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05507632
Sponsor's protocol ID
NFEC-2022-256
Status last verified
May 2026
First submitted
15 Aug 2022
Last updated
1 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Donafenib plus Sintilimab in combination with transarterial chemoembolisation in people with Unresectable Hepatocellular Carcinoma, run by Nanfang Hospital, Southern Medical University at 1 site in 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 11 inclusion and 26 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: under way, not looking for participants, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) as assessed by mRECIST (time frame: From date of first dose of study treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination (up to approximately 3 years)). 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 NCT05507632.

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 1 Jun 2026.

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