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Hepatocellular CarcinomaPhase 2NCT06498622

Adjuvant Treatment of Patients With High Risk of Recurrent Hepatocellular Carcinoma With Donafenib in Combination With Envafolimab

A Phase 2 study testing Donafenib + Envafolimab in people with Hepatocellular Carcinoma, run by Anhui Provincial Hospital at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a multi-center, single arm study to evaluate the efficacy and safety of donafenib in combination with envafolimab treatment in patients with high risk of recurrent hepatocellular carcinoma after radical surgery. 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 + Envafolimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
2 sitesChina
Study dates
20 Jul 2024to 20 May 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

  • 18-80 years old, male and female.
  • Subjects voluntarily enrolled in this study and signed the informed consent, good compliance and co-operated with the follow-up.
  • Primary hepatocellular carcinoma with postoperative histopathological diagnosis of HCC and negative margins.
  • Presence of any of the following high-risk factors for recurrence: ① tumor size ≥5.0cm combined with microvascular invasion; ② number of tumors ≥3; ③ presence of portal vein cancer thrombus (vp1 or vp2 type).
  • No recurrence of metastasis confirmed by imaging examination 3-7 weeks after surgery.
  • ECOG score of 0-1.
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  • Expected survival ≥ 3 months.
  • Child-Pugh score ≤ 7.
  • Subjects with no previous antitumour therapy (except antiviral therapy)
  • No extra-hepatic metastases or lymph node metastases.
  • No significant abnormality in routine laboratory tests (blood test, liver and kidney function, coagulation function, etc.): (1) Criteria for routine blood tests need to be met (no blood and blood products transfusion within 14 days): a. Absolute neutrophil value (ANC) ≥ 1.5*10^9/L; b. Haemoglobin (HGB) ≥ 90g/L; c. Platelet count (PLT) ≥ 75*10^9/L. (2) Biochemical tests need to meet the following criteria: a. Serum albumin (ALB) ≥ 35g/L; b. Serum total bilirubin (TBIL) < 1.5*Upper Limit of Normal (ULN); c. Serum glutamic transaminase (AST), alanine aminotransferase (ALT) < 2.5*ULN; d. Serum creatinine ≤ 1.5*ULN.

Who cannot join

  • Previous histologically/cytologically confirmed fibroplaque-containing hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other components.
  • Histologically confirmed positive resection margin (R1 resection), presence of lymph node metastasis or extrahepatic metastasis.
  • Previous or current malignancy other than hepatocellular carcinoma.
  • History of hepatic encephalopathy or history of liver transplantation.
  • Previous history of allergy to any component of the test drug: Envafolimab monoclonal antibody, donafini.
  • Subjects with poorly controlled persistent postoperative pleural, abdominal or pericardial effusion.
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  • Previous antitumour therapy (except antiviral therapy).
  • History of interstitial lung disease (except radiation pneumonitis not treated with hormones), non-infectious pneumonia.
  • Presence of any active autoimmune disease or history of autoimmune disease in the subject (e.g., the following, but not limited to: autoimmune hepatitis, interstitial pneumonitis, uveitis, enterocolitis, hepatitis, pituitary gland inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism subjects with vitiligo or asthma that has been in complete remission in childhood and does not require any intervention in adulthood may be enrolled subjects with asthma that requires medical intervention with bronchodilators cannot be included).
  • Subjects who are on immunosuppressive, or systemic, or absorbable topical hormone therapy for immunosuppression (dose >10mg/day prednisone or other equipotent hormone) and continue to use it within 2 weeks prior to enrolment.
  • A serious infection (CTCAE > grade 2) such as severe pneumonia, bacteraemia, or infectious co-morbidities requiring hospitalisation has occurred 4 weeks prior to the first use of study drug.
  • Subjects who have experienced acute cardiovascular disease such as acute cerebral infarction, acute coronary syndrome, etc. within 1 month, with cardiovascular clinical symptoms or disease not well controlled.
  • According to NYHA standard, grade III to IV cardiac insufficiency, or cardiac ultrasound examination suggests that the left ventricular ejection fraction (LVEF) <50%
  • Uncontrollable hypertension with treated systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg, hypertensive crisis or history of hypertensive encephalopathy
  • Patients with a definite tendency to gastrointestinal bleeding, including the following: patients with locally active ulcerative lesions and fecal occult blood {(++) may not be enrolled} those with a history of black stools and vomiting of blood within 2 months.
  • Those with abnormal coagulation function (INR>1.5 APTT>1.5 ULN) and bleeding tendency.
  • Prolonged unhealed wounds or fractures major surgical procedures or severe traumatic injuries, fractures or ulcers within 4 weeks.
  • Subjects with congenital or acquired immune deficiency (e.g., HIV-infected individuals), or active hepatitis (Hepatitis B reference: HBV DNA test value exceeds the upper limit of normal Hepatitis C reference: HCV viral titre or RNA test value exceeds the upper limit of normal).
  • Patients with a history of psychotropic substance abuse that cannot be stopped or patients with mental disorders.
  • Patients with concomitant illnesses that, in the investigator's judgement, are a serious hazard to patient safety or interfere with the patient's ability to complete the study.
  • Pregnant women, lactating women, and women of childbearing age who are not using adequate contraception.
  • In the judgement of the investigator, Patients who are not suitable for inclusion.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lianxin Liu contact

+86 18096656677

liulx@ustc.edu.cn

Ji-Zhou Wang contact

+86 13836135864

wangjoe@ustc.edu.cn

China2 sites, 2 recruiting

  • No.2 People's Hospital of Fuyang city

    Fuyang, Anhui, 236015

    DaYong Luo, +86 13805587172, fyldy7172@sina.com

    Recruiting

  • Anhui province hospital

    Hefei, Anhui, 230000

    Lianxin Liu, M.D., 13845159888, liulx@ustc.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Adjuvant Treatment of Patients With High Risk of Recurrent Hepatocellular Carcinoma After Radical Surgery With Donafenib in Combination With Envafolimab: a Prospective, Multicentre, Single-arm Phase II Clinical Study

This is a multi-center, single arm study to evaluate the efficacy and safety of donafenib in combination with envafolimab treatment in patients with high risk of recurrent hepatocellular carcinoma after radical surgery.

Read the detailed description

Hepatocellular carcinoma (HCC) is a malignant tumor with high morbidity and mortality. Surgical resection is the most important radical treatment. However, the recurrence rate is high especially in the patients with high risk of recurrence after curative resection. How to reduce postoperative recurrence and improve survival is currently a direction that is worth exploring.

Until now there is no standard postoperative adjuvant therapy. Various adjuvant treatment methods including immunotherapy, targeted therapy, TACE are being studied. This study is to explore the efficacy and safety of donafenib in combination with envafolimab treatment in HCC patients who are at high risk of recurrence after curative resection.

Being tested
Donafenib + Envafolimab
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 + EnvafolimabDrug

    Drug: Envafolimab Envafolimab 300mg IH D1 q3w Other Name: Immunotherapy, Anti-PD-L1 antibody

    Drug: Donafenib Donafenib 100mg PO bid Other Name: tyrosine kinase inhibitor, TKI

Study groups in NCT06498622
Study groupRoleWhat they receive
Donafenib 100mg PO bid + Envafolimab 300mg IH D1 q3wExperimentalDonafenib：100mg，PO，bid；Treatment cycle 6-12 months Envafolimab：300mg, IH，D1，q3w；Treatment cycle 6-12 months or 8-16 sessions Donafenib and Envafolimab will be administered until the disease recurrence, intolerable toxicity, death, withdrawal of consent or completion of 16 cycles of Envafolimab.
Receives: Drug: Donafenib + Envafolimab

What is being measured

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

  1. RFS

    Recurrence Free Survival [Time Frame: Observation period 24 month] RFS was defined as the time from randomization to the first documented occurrence of local, regional, or metastatic HCC or death from any cause, whichever first occurred.

    Measured: Observation period 24 months

Secondary outcomes (4)

  1. OS

    Overall Survival (OS）[Time Frame: 24 months] OS is defined as the time from the date of curative resection until death due to any cause.

    Measured: 24 months

  2. 2-year RFS rate

    2-year Recurrence Free Survival Rate (2-year RFS rate) [Time Frame: Observation period 24 months] 2-year RFS rate is defined as the proportion of patients alive and free of recurrence at 2 years after curative resection.

    Measured: Observation period 24 months

  3. 2-year OS rate

    2-year Overall Survival (OS）Rate [Time Frame: 24 months] 2-year RFS rate is defined as the proportion of patients alive at 2 years after curative resection.

    Measured: 24 months

  4. AEs

    Adverse Events (AEs) [ Time Frame: 24 months ] The grade of AEs and the number of patients with AEs are assessed based on CTCAE v5.0

    Measured: 24 months

Timeline

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

  1. First posted12 Jul 2024
  2. Study start20 Jul 2024 (estimated)
  3. Primary completion20 May 2027 (estimated)
  4. Study completion20 May 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
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06498622
Sponsor's protocol ID
2023KY433
Status last verified
Jul 2024
First submitted
7 Jul 2024
Last updated
12 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Donafenib + Envafolimab in people with Hepatocellular Carcinoma, run by Anhui Provincial Hospital at 2 sites 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 22 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: looking for participants now, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Contact Lianxin Liu (+86 18096656677, liulx@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

RFS (time frame: Observation period 24 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 NCT06498622.

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 12 Jul 2024; AzTrials last refreshed its copy on 8 Nov 2026.

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