AzTrials
AzTrials

HCC - Hepatocellular CarcinomaPhase 2NCT07584018

The DoHAICs Study Expansion Phase

A Phase 2 study testing Donafenib, sintilimab and HAIC in people with HCC - Hepatocellular Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital.

Not yet recruiting

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

Official record
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Trial summary

We explored the efficacy and safety of the first-line treatment of unresectable hepatocellular carcinoma with donafenib combined with hepatic artery infusion chemotherapy (HAIC) and sintilimab . Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
HCC - Hepatocellular Carcinoma
What is being tested?
Donafenib, sintilimab and HAIC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
No sites listed yet
Study dates
20 May 2026to 1 Jun 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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily participate in the trial and provide written informed consent.
  • Age between 18 and 80 years (inclusive), regardless of gender.
  • Patients with hepatocellular carcinoma (HCC) clinically diagnosed per the "Standard for Diagnosis and Treatment of Primary Liver Cancer (2024 Edition)" or confirmed by histology/cytology.
  • Patients with inoperable or metastatic hepatocellular carcinoma.
  • No prior systemic therapy for advanced disease. Patients who received adjuvant chemotherapy following local therapy are eligible if chemotherapy was completed >12 months ago and disease progression or metastasis has occurred.
  • Completion of the last interventional therapy, radiotherapy, or ablation therapy >4 weeks prior.
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  • For patients with prior hepatectomy, resection must have been R0, and tumor recurrence must have occurred more than 24 months after surgery.
  • At least one measurable lesion as defined by RECIST 1.1 criteria.
  • Life expectancy ≥3 months.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  • Child-Pugh score ≤7.
  • Able and willing to comply with the protocol for the observation of adverse events and efficacy.
  • Adequate organ function, defined as meeting the following criteria:
  • Hematological function (without transfusion or granulocyte colony-stimulating factor [G-CSF] support within 14 days prior to screening):
  • Hemoglobin ≥90 g/L.
  • Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L.
  • Platelet count ≥75 × 10⁹/L.
  • Biochemical tests (without albumin infusion within 14 days prior to screening):
  • Albumin ≥28 g/L.
  • Total bilirubin ≤2 × upper limit of normal (ULN).
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤5 × ULN.
  • Alkaline phosphatase (ALP) ≤5 × ULN.
  • Serum creatinine ≤1.5 × ULN.
  • Coagulation function:
  • International normalized ratio (INR) or prothrombin time (PT) ≤1.5 × ULN.
  • Activated partial thromboplastin time (APTT) ≤1.5 × ULN.

Who cannot join

  • Histologically/cytologically confirmed components such as fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or cholangiocarcinoma.
  • History of malignancies other than hepatocellular carcinoma, except under the following circumstances:
  • The patient has undergone potentially curative treatment with no evidence of that disease for 5 years.
  • Successfully resected basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, or other carcinoma in situ.
  • Diffuse tumor lesions.
  • History of hepatic encephalopathy, hepatorenal syndrome, or liver transplantation.
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  • Clinically symptomatic pleural effusion, ascites, or pericardial effusion requiring drainage.
  • Central nervous system metastases.
  • History of severe psychiatric illness.
  • Diseases affecting the absorption, distribution, metabolism, or excretion of the investigational drug (e.g., severe vomiting, chronic diarrhea, intestinal obstruction, malabsorption, etc.).
  • Prior allogeneic stem cell or solid organ transplantation.
  • Prior treatment with anti-VEGF/VEGFR, RAF, MEK pathway targeted therapies (e.g., sorafenib, lenvatinib, regorafenib) or immunomodulators (e.g., anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies).
  • Prior other systemic anti-tumor therapy, including Chinese herbal medicine with anti-tumor indications, completed less than 2 weeks before study drug initiation; or patients with adverse events from prior therapy not recovered to ≤ Grade 1 per CTCAE (excluding alopecia and Grade 1/2 neuropathy caused by oxaliplatin).
  • Concurrent use of medications known to prolong QTc interval and/or induce Torsades de Pointes (TdP), or medications that affect drug metabolism.
  • Past or present congenital or acquired immunodeficiency diseases.
  • Active or history of autoimmune or inflammatory diseases (including but not limited to: autoimmune hepatitis, interstitial pneumonia, inflammatory bowel disease, systemic lupus erythematosus, vasculitis, uveitis, hypophysitis, hyper- or hypothyroidism, asthma requiring bronchodilators, etc.). Patients with vitiligo or asthma that was fully resolved in childhood and requires no intervention in adulthood may be included.
  • Use of systemic immunosuppressive medication within 2 weeks prior to enrollment, or anticipated requirement for such medication during the study, except for:
  • Intranasal, inhaled, topical, or local corticosteroid injections (e.g., intra-articular).
  • Systemic corticosteroids at physiological doses not exceeding 10 mg/day prednisone or equivalent.
  • Prophylactic use of corticosteroids for hypersensitivity reactions.
  • Known or suspected hypersensitivity to donafenib, drugs of the same class, or history of hypersensitivity to chimeric or humanized antibodies or fusion proteins, or allergy to any excipient of the investigational drug.
  • Active bleeding or coagulation disorders, bleeding tendency, or undergoing thrombolytic, anticoagulant, or antiplatelet therapy.
  • Thrombotic or thromboembolic events within the past 6 months, such as stroke and/or transient ischemic attack, deep vein thrombosis, pulmonary embolism, etc.
  • History of esophageal or gastric variceal bleeding due to portal hypertension within the past 6 months, or any life-threatening bleeding event within the past 3 months.
  • Significant cardiovascular disease, including but not limited to: acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting within the past 6 months; congestive heart failure (NYHA class >2); poorly controlled arrhythmias requiring pacemaker treatment; uncontrolled hypertension (systolic BP ≥140 mmHg and/or diastolic BP ≥90 mmHg).
  • Other clinically significant abnormalities, deemed by the investigator to affect safety evaluation, such as uncontrolled diabetes, chronic kidney disease, Grade II or higher peripheral neuropathy (CTCAE v6.0), abnormal thyroid function, etc.
  • Active or poorly controlled severe infection; active infections including:
  • Positive for Human Immunodeficiency Virus (HIV) (HIV1/2 antibodies).
  • Active Hepatitis B (HBsAg positive or HBV DNA >2000 IU/mL with abnormal liver function).
  • Active Hepatitis C (HCV antibody positive or HCV RNA ≥10³ copies/mL with abnormal liver function).
  • Active tuberculosis.
  • Other uncontrolled active infections (CTCAE v6.0 > Grade 2).
  • Incomplete recovery from surgery, such as unhealed wounds or severe postoperative complications.
  • Pregnancy, lactation, or patients of childbearing potential unwilling or unable to use effective contraception.

About this study

Official title: Clinical Study on the Efficacy and Safety of Donafenib Combined With Hepatic Artery Infusion Chemotherapy and Sintilimab as the First-line Treatment for Unresectable Hepatocellular Carcinoma - the DoHAICs Study Expansion Phase

We explored the efficacy and safety of the first-line treatment of unresectable hepatocellular carcinoma with donafenib combined with hepatic artery infusion chemotherapy (HAIC) and sintilimab .

Being tested
Donafenib, sintilimab, HAIC
Keywords
Hepatocellular carcinoma;, Hepatic artery infusion chemotherapy, Surgical resection
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • DonafenibDrug

    Donafenib (200 mg twice daily, taken orally, initiated 3-7 days before the first HAIC session)

  • sintilimabDrug

    sintilimab (200 mg intravenously every 3 weeks, administered 0-1 day before each HAIC treatment)

  • HAICProcedure or surgery

    HAIC (oxaliplatin 85 mg/m2 over 2 hours, leucovorin 400 mg/m2 over 2 hours, bolus fluorouracil 400 mg/m2 within the first 10 minutes, followed by fluorouracil infusion 1200 mg/m2 over 23 hours, every 3 weeks.)

Study groups in NCT07584018
Study groupRoleWhat they receive
Donafenib combined with hepatic artery infusion chemotherapy and sintilimabExperimentalDonafenib combined with hepatic artery infusion chemotherapy and sintilimab injection as the first-line treatment for unresectable hepatocellular carcinoma
Receives: Drug: Donafenib; Drug: sintilimab; Procedure: HAIC

What is being measured

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

  1. event-free survival

    Measured: The time from enrollment to the date of first documented progression, recurrence, or death from any cause, whichever came first, assessed up to 36 months

Timeline

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

  1. First posted13 May 2026
  2. Study start20 May 2026 (estimated)
  3. Primary completion1 Jun 2027 (estimated)
  4. Study completion1 Jun 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
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07584018
Sponsor's protocol ID
E20251318
Status last verified
Dec 2025
First submitted
22 Dec 2025
Last updated
13 May 2026
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 Donafenib, sintilimab and HAIC in people with HCC - Hepatocellular Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital.

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 26 inclusion and 34 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 13 May 2026. 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?

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?

event-free survival (time frame: The time from enrollment to the date of first documented progression, recurrence, or death from any cause, whichever came first, assessed up to 36 months). 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 NCT07584018.

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 13 May 2026.

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