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Hepatocellular CarcinomaPhase 2NCT05166772

Donafenib Combine With Sintilimab and HAIC (Hepatic Artery Infusion Chemotherapy，HAIC）in the First-line Treatment of Unresectable Hepatocellular Carcinoma

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

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The investigators design a phase IIB clinical study to explore the efficacy and safety of Donafenib combined with Sintilimab and HAIC in the first-line treatment of unresectable hepatocellular carcinoma Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Donafenib, Sintilimab and HAIC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
Dec 2021to Dec 2024
Phase
Phase 2
Are there results?
None posted in the registry

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 join the study and sign the informed consent;
  • Age 18 ~ 80 years old (including 80 years old), male and female;
  • Patients with hepatohcellular carcinoma diagnosed clinically or confirmed by histology / cytology according to the code for diagnosis and treatment of primary liver cancer (2019 Edition);
  • Patients with unresectable or metastatic hepatocellular carcinoma;
  • No systematic treatment. If receiving adjuvant chemotherapy after local treatment more than 12 months, and patients with disease progression or metastasis can also be included in the group;
  • The end time of the last intervention, radiotherapy and ablation should be > 4 weeks;
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  • Patients who underwent hepatectomy in the past should be R0 resection, and the tumor recurrence should be more than 24 months after operation;
  • At least one assessable lesion (RECIST 1.1 criteria);
  • Expected survival time ≥ 3 months;
  • ECOG 0 ~ 1;
  • Child Pugh ≤ 7;
  • Be able to cooperate to observe adverse events;
  • Major organs are functioning normally.
  • Hemoglobin ≥ 90 g / L;
  • ANC ≥ 1.5 × 109/L；
  • Platelet count ≥ 75 × 109/L；
  • Albumin ≥ 28 g / L;
  • Total bilirubin ≤ 2 × ULN;
  • AST, ALT ≤ 5 × ULN；
  • ALP ≤ 5 × ULN；
  • Creatinine ≤ 1.5 × ULN；
  • INR or PT ≤ 1.5 × ULN； J) APTT ≤ 1.5 × ULN。

Who cannot join

  • Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other components confirmed by histology / cytology in the past;
  • Have a history of malignancy other than hepatocellular carcinoma unless the following criteria are met:
  • The patient has received possible curative treatment and there is no evidence of the disease within 5 years; B) Successful resection of basal cell carcinoma of skin, squamous cell carcinoma of skin, superficial bladder carcinoma, carcinoma in situ of cervix and other cancers in situ
  • Diffuse tumor lesions;
  • Tumor vascular invasion occurs in one or more of the following situations:
  • Involving superior mesenteric vein;
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  • Involving inferior vena cava;
  • History of hepatic encephalopathy, hepatorenal syndrome, or history of liver transplantation;
  • Pleural effusion, ascites and pericardial effusion with clinical symptoms requiring drainage;
  • Central system metastasis;
  • Previous history of severe mental illness;
  • Have a disease that affects absorption, distribution, metabolism, or clearance of the drug under study (such as severe vomiting, chronic diarrhea, intestinal obstruction, absorption disorder, etc.);
  • Previous allogeneic stem cell or parenchymal organ transplantation;
  • Previously received targeted therapy of anti VEGF and / or signal pathways such as VEGFR, RAF and MEK, such as sorafenib, renvatinib and regofinib, or immunomodulator therapy such as anti-PD-1, anti-PD-L1 and anti-CTLA-4;
  • Patients who have received other anti-tumor systemic treatment in the past, including traditional Chinese medicine with anti-tumor indications less than 2 weeks before the administration of this study, or the adverse events caused by previous treatment have not recovered to ≤ CTCAE level 1; The toxicity of previous anti-tumor treatment did not include grade 1 / 2 neurotoxicity and hair loss caused by oxaliplatin;
  • Taking drugs that may prolong QTc and / or induce tip twist transition ventricular tachycardia (TDP) or drugs that affect metabolism at the same time;
  • Previous or current congenital or acquired immunodeficiency disease;
  • Active or previously documented autoimmune disease or inflammatory disease.
  • Previous allogeneic stem cell or parenchymal organ transplantation;
  • Systemic immunosuppressive drugs were used within 2 weeks before enrollment, or systemic immunosuppressive drugs expect to be needed during the study, except for the following:
  • Intranasal, inhalation, topical or local injection (such as intra-articular injection) of corticosteroids; e) Systemic corticosteroids with dose not exceeding 10 mg / day, prednisone or other effects; f) Prophylactic use of corticosteroids for hypersensitivity;
  • Allergy to Donafenib or similar drugs, or history of hypersensitivity to chimeric or humanized antibodies or fusion proteins, or allergy to the excipients of the study drugs;
  • Have active bleeding or abnormal coagulation function, have bleeding tendency or are receiving thrombolytic, anticoagulant or antiplatelet therapy;
  • Thrombosis or thromboembolism events occurred in the past 6 months, such as stroke and / or transient ischemic attack, deep vein thrombosis, pulmonary embolism, etc;
  • Bleeding events of esophageal or gastric varices caused by portal hypertension in the past 6 months, or any life-threatening bleeding events in 3 months;
  • Cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe / unstable angina or coronary artery bypass grafting in the past 6 months, congestive heart failure (NYHA grade > 2), arrhythmias poorly controlled or requiring pacemaker treatment, and hypertension not controlled by drugs (systolic blood pressure ≥ 140 mmHg and / or diastolic blood pressure ≥ 90 mmHg);
  • Other significant clinical and laboratory abnormalities considered by the investigator to affect safety;
  • Severe infections in the active stage or under clinical control; Active infections include:
  • HIV1/2 is positive.
  • HBsAg positive or HBV DNA > 2000iu/ml and abnormal liver function;
  • HCV antibody positive or HCV RNA ≥ 103 copies/ml and abnormal liver function;
  • Active tuberculosis;
  • Other uncontrollable active infections (CTCAE V5.0 > grade 2);
  • Not recovered from the operation, such as unhealed incision or serious postoperative complications;
  • Pregnant or lactating women, and women or men with fertility are unwilling or unable to take effective contraceptive measures.

Trial locations and contacts

No sites are listed yet.

WEI ZHANG, Doctor contact

18622025401

zhangweitjch@163.com

About this study

Official title: Efficacy and Safety of Donafenib Combine With Sintilimab and HAIC (Hepatic Artery Infusion Chemotherapy，HAIC） in the First-line Treatment of Unresectable Hepatocellular Carcinoma

The investigators design a phase IIB clinical study to explore the efficacy and safety of Donafenib combined with Sintilimab and HAIC in the first-line treatment of unresectable hepatocellular carcinoma

Read the detailed description

This trial is a single-arm, non-randomized and single-center clinical study of Donafenib combined with Sintilimab and HAIC in the first-line treatment of unresectable hepatocellular carcinoma. It will estimate that 30 patients who met the study criteria will be enrolled in Tianjin Medical University Cancer Institute and Hospital and treat with Donafenib combined with Sintilimab and HAIC. The investigators will follow up and collect subjects' data monthly to evaluate the efficacy and safety of treatment, including overall survival and time to progression.

Being tested
Donafenib, Sintilimab, HAIC
Keywords
Hepatocellular carcinoma, HAIC, Sintilimab, Donafenib
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

    200 mg BID，oral administration will start before the first HAIC treatment.

  • SintilimabDrug

    200 mg，Q3W，Intravenous infusion will performe before HAIC treatment.

  • HAICOther

    Q3W. The total number of HAIC treatments was determined by the investigator based on patient needs. Dose: Oxaliplatin 85 mg / m2 for 2h, Calcium folinate 400 mg / m2 for 2h, 5-FU 400 mg / m2 for 10min, followed by 5-FU 1200 mg / m2 for 23 hours);

Study groups in NCT05166772
Study groupRoleWhat they receive
Donafenib combined with Sintilimab and HAICExperimentalDonafenib：200mg bid； Sintilimab：200mg Q3D； HAIC：Q3W；
Receives: Drug: Donafenib; Drug: Sintilimab; Other: HAIC

What is being measured

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

  1. ORR（Objective Response Rate）

    The rate of participants that achieve either a complete response (CR) or a partial response (PR).

    Measured: 1 year

Secondary outcomes (6)

  1. OS（Overall survival）

    Overall survival is defined as time from the start of treatment until death due to any reason.

    Measured: 3 years

  2. TTP（Time to progress）

    Time to Progression (TTP) defined as the time from the date of randomization to the date of first documented radiological confirmation of disease progression.

    Measured: 3 years

  3. PFS（Progress free survival）

    PFS during the retreatment phase was assessed by the site Investigator using RECIST 1.1 and defined as the time from the date of enrollment until the date of objective disease progression or death (by any cause in the absence of progression).

    Measured: 3 years

  4. DCR（Disease control rate）

    The percentage of cases with remission (PR + CR) and stable lesions (SD) after treatment was assessable.

    Measured: 3 years

  5. DOR（Duration of response）

    DoR was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression. The time of the initial response was defined as the latest of the dates contributing toward the first visit response of CR or PR. If a patient did not progress following a response, then their DoR was censored at the PFS censoring time.

    Measured: 3 years

  6. AE（Adverse events）

    Safety as measured by number and grade of adverse events

    Measured: 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 posted22 Dec 2021
  2. Study startDec 2021 (estimated)
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 2024 (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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05166772
Sponsor's protocol ID
E20210872
Status last verified
Nov 2021
First submitted
29 Nov 2021
Last updated
22 Dec 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Gao W, Pan ZL, Zhao XH, Yang L, Cao JB, Li DY, Zheng HJ, Liu C, Li GT, Bao X, Liu XM, Zhang WH, Zhu XL, Xiao BH, Song TQ, Li Q, Lu W, Xing WG, Zhang W. Donafenib and sintilimab combined with hepatic arterial infusion chemotherapy for unresectable hepatocellular carcinoma: a prospective, single-arm phase II trial (DoHAICs study). EClinicalMedicine. 2025 May 5;83:103217. doi: 10.1016/j.eclinm.2025.103217. eCollection 2025 May.

    PubMed 40475000

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Donafenib, Sintilimab and HAIC in people with 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 22 inclusion and 35 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: status not confirmed, as of the sponsor's last update on 22 Dec 2021. 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?

Results are not available in the source record.

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

Contact WEI ZHANG, Doctor (18622025401, zhangweitjch@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR（Objective Response Rate） (time frame: 1 year). 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 NCT05166772, which also lists 1 linked publication.

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 22 Dec 2021.

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