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Hepatocellular CarcinomaPhase 2NCT05545124

Study of Donafenib Combined With Tislelizumab in the Adjuvant Treatment of Primary HCC With High Risk of Recurrence

A Phase 2 study testing Donafenib + Tislelizumab in people with Hepatocellular Carcinoma, run by Henan Cancer 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 The sponsor has not verified this record for over two years, so it may be out of date.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

To explore the safety and preliminary efficacy of donafenib combined with tislelizumab in adjuvant therapy after radical surgical resection of primary hepatocellular carcinoma with high risk of recurrence. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Donafenib + Tislelizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
No sites listed yet
Study dates
Nov 2022to Nov 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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 ~ 75 years old (including the threshold value), male or female;
  • Received radical resection of liver cancer 4-8 weeks before enrollment;
  • Pathologically diagnosed as hepatocellular carcinoma and assessed by the investigator to have a high risk of recurrence;
  • No recurrence or metastasis was confirmed by imaging examination before enrollment;
  • Child-Pugh score of liver function A;
  • Eastern Cooperative Oncology Group (ECOG) physical status (PS) score of 0-1;
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  • The expected survival period is not less than 3 months;
  • The doctor's decision to use Donafenib must be done before the patient is enrolled in the study;
  • For HBV-infected patients, if HBV-DNA is ≥104copies/ml within 14 days before enrollment, they should take antiviral treatment (entecavir is recommended), and then enter the study when it drops to <104copies/ml, and continue antiviral treatment and monitoring Liver function and serum HBV-DNA level;
  • Have sufficient organ functional reserve
  • Female patients with reproductive potential (referring to nonmenopausal or surgical sterilization), the serum pregnancy test results must be negative within 7 days before the administration of the study drug; female or male patients with reproductive potential, during the use of the study drug And within 60 days after the last dose, reliable contraceptive measures must be used;
  • Patients are voluntarily enrolled, can provide written informed consent, and can understand and comply with the experimental protocol, taking medication and follow-up.

Who cannot join

  • Pathologically diagnosed as mixed hepatocellular carcinoma-intrahepatic cholangiocarcinoma (HCC-ICC) or fibrolamellar hepatocellular carcinoma;
  • Past or current patients with congenital or acquired immunodeficiency diseases;
  • Active or previously recorded autoimmune diseases or inflammatory diseases, with vitiligo or asthma that has been completely resolved in childhood, without any intervention in adulthood can be included;
  • Combined with other liver diseases, including uncontrolled alcoholic hepatitis or other hepatitis, decompensated liver cirrhosis, severe fatty liver, hereditary liver disease, liver atrophy, superior vena cava syndrome, portal hypertension.
  • Have a history of idiopathic pulmonary fibrosis, organizing pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia, idiopathic pneumonia, or evidence of active pneumonia found during chest CT scan screening;
  • Other malignancies within 5 years, unless the patient has received potentially curative treatment and there is no evidence of the disease within 5 years, but this time requirement (that is, within 5 years) does not apply to basal cell carcinoma of the skin that has been successfully resected , skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ or other in situ carcinoma patients;
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  • Have a history of serious mental illness in the past;
  • Suffering from diseases that affect the absorption, distribution, metabolism or clearance of the study drug (such as severe vomiting, chronic diarrhea, intestinal obstruction, malabsorption, etc.);
  • Received major surgery within 4 weeks before enrollment (determined by the investigator);
  • Patients who have received allogeneic stem cell or solid organ transplantation in the past, including patients after liver transplantation;
  • Received other anti-tumor systemic therapy before enrollment, including other traditional Chinese medicines with anti-tumor indications, less than 2 weeks or 5 drug half-lives (whichever is longer) after the completion of the treatment and before the drug in this study. , or patients whose adverse events caused by preoperative treatment did not recover to ≤CTCAE grade 1;
  • Received other adjuvant therapy after surgery (except antiviral therapy);
  • Systemic immunosuppressive drug therapy has been used within 2 weeks before enrollment, or systemic immunosuppressive drug therapy is expected to be required during the study period
  • Concomitant use of drugs that may prolong QTc and/or induce torsades de pointes (Tdp) or drugs that affect drug metabolism;
  • The patient is known or suspected to have a history of allergy to tyrosine kinase inhibitor (TKI) drugs and PD-1 drugs, or to the excipients of the study drug;
  • There is uncontrollable hepatic encephalopathy, hepatorenal syndrome, ascites, pleural effusion or pericardial effusion;
  • Active bleeding or abnormal coagulation function, bleeding tendency or receiving thrombolysis, anticoagulation or antiplatelet therapy;
  • There is a history of gastrointestinal bleeding within the past 4 weeks or a clear tendency of gastrointestinal bleeding (such as: known local active ulcer lesions, fecal occult blood ++++ or above, such as persistent fecal occult blood+, gastroscopic examination should be performed), Or other conditions that may cause gastrointestinal bleeding as determined by the investigator (such as severe gastric fundus/esophageal varices);
  • Gastrointestinal perforation, abdominal fistula or abdominal abscess occurred within the past 6 months;
  • Thrombosis or thromboembolic events have occurred in the past 6 months, such as stroke and/or transient ischemic attack, deep vein thrombosis, pulmonary embolism, etc.;
  • Cardiovascular disease with significant clinical significance, including but not limited to acute myocardial infarction, severe/unstable angina pectoris or coronary artery bypass grafting within the past 6 months, congestive heart failure (NYHA classification > grade 2 of the New York Heart Association ), poorly controlled arrhythmias that require pacemaker therapy, and uncontrolled hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg);
  • Active infection;
  • Other significant clinical and laboratory abnormalities that the investigators consider to affect the safety evaluation, such as: uncontrolled diabetes mellitus, chronic kidney disease, peripheral neuropathy of grade II or above (CTCAE V5.0), abnormal thyroid function, etc.;
  • Have not recovered from surgery, such as unhealed incisions or serious postoperative complications;
  • Pregnant or breastfeeding women, as well as female or male patients with reproductive potential who are unwilling or unable to take effective contraceptive measures;
  • History of alcohol, psychotropic or other drug abuse within the past 6 months;
  • Received clinical trials of other drugs or medical devices within 4 weeks before enrollment;
  • Unable to follow the research protocol to receive treatment or follow up regularly;
  • Any other researchers who think that they cannot be included in the group

Trial locations and contacts

No sites are listed yet.

Jinxue Zhou, Ph.D. contact

13837175001

zhoujx888@126.com

Zhengzheng Wang contact

13526638243

253700193@qq.com

About this study

Official title: Clinical Study of Donafenib Combined With Tislelizumab in the Adjuvant Therapy of High-risk Recurrence-risk Primary Hepatocellular Carcinoma After Radical Surgical Resection

To explore the safety and preliminary efficacy of donafenib combined with tislelizumab in adjuvant therapy after radical surgical resection of primary hepatocellular carcinoma with high risk of recurrence.

Read the detailed description

This study is a single-center, single-arm, open-label clinical study. For HCC patients who the investigator believes can benefit from adjuvant treatment with donafenib combined with PD-1 monoclonal antibody, they will sign an informed consent form, and then start donafenib within 1-2 months after radical surgery (stable disease assessment or improvement). Adjuvant therapy with fenib combined with tislelizumab for 6 months, to explore the safety and efficacy of postoperative adjuvant therapy with donafenib combined with tislelizumab.

Being tested
Donafenib + Tislelizumab
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 + TislelizumabDrug

    Donafenib 100mg, BID+Tislelizumab 200mg, D1; q3w

Study groups in NCT05545124
Study groupRoleWhat they receive
Donafenib+TislelizumabExperimentalDonafenib+Tislelizumab
Receives: Drug: Donafenib + Tislelizumab

What is being measured

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

  1. 1-year recurrence-free survival

    Ratio of patients from first treatment to disease recurrence within 1 year

    Measured: 1 years

Secondary outcomes (3)

  1. recurrence-free survival with surgical resection

    Time elapsed from surgical resection to tumor recurrence or death from any cause (if the subject died before disease recurrence)

    Measured: 2 years

  2. overall survival

    Time from enrollment date to date of death from any cause

    Measured: up to 1 years

  3. adverse events

    Incidence of adverse events in combination immunization with donafenib

    Measured: up to 1 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 Sep 2022
  2. Study startNov 2022 (estimated)
  3. Primary completionNov 2023 (estimated)
  4. Study completionNov 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
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05545124
Sponsor's protocol ID
2022-388
Status last verified
Sep 2022
First submitted
15 Sep 2022
Last updated
19 Sep 2022
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 + Tislelizumab in people with Hepatocellular Carcinoma, run by Henan Cancer 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 12 inclusion and 29 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 19 Sep 2022. 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 Jinxue Zhou, Ph.D. (13837175001, zhoujx888@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1-year recurrence-free survival (time frame: 1 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 NCT05545124.

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 19 Sep 2022.

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