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Carcinoma, HepatocellularPhase 2NCT06454578

Adjuvant Adebrelimab Plus Apatinib for Participants With HCC at High-risk of Recurrence After Curative Resection

A Phase 2 study testing Adebrelimab + Apatinib in people with Carcinoma, Hepatocellular, run by Qilu Hospital of Shandong University at 1 site 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 single-center, single-arm, open-label clinical study to evaluate the efficacy and safety of Adebrelimab plus Apatinib as adjuvant therapy in hepatocellular carcinoma (HCC) participants who are at high risk of recurrence after curative resection. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Hepatocellular
What is being tested?
Adebrelimab + Apatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
24 Jul 2024to 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must meet all of the following conditions in order to be enrolled in this study:
  • Voluntarily participate in this study and sign an informed consent form.
  • Participants diagnosed with HCC through pathological histology/cytology or clinically diagnosed with HCC according to the Diagnosis and Treatment Guidelines for Primary Liver Cancer (2024 Edition).
  • Within 4-12 weeks prior to enrollment, radical resection surgery was performed.
  • Complete recovery from surgical resection within 4 weeks prior to enrollment.
  • High risk factors for postoperative recurrence of hepatocellular carcinoma include multiple tumors, tumor length>5 cm, poor tumor differentiation (Edmondson III-IV grade), margin ≤ 1 cm, invasion of Microvasculature or large vessels, lymph node metastasis, sustained abnormalities in AFP or abnormal prothrombin , etc.
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  • Child Pugh liver function rating within 7 days prior to randomization: A or B (≤ 7 points).
  • ECOG PS score within 7 days before randomization: 0-1 points.
  • Have not received systematic anti-tumor treatment for hepatocellular carcinoma in the past.
  • Expected survival time ≥ 12 weeks.
  • The main organ functions meet the following requirements (within 7 days before randomization):
  • Blood routine examination: (excluding hemoglobin, no blood transfusion within 14 days prior to screening, no use of granulocyte colony-stimulating factor [G-CSF], no medication correction):
  • Neutrophil absolute count ≥ 1.5 × 109/L; Platelets ≥ 75 × 10^9/L; • Hemoglobin ≥ 90 g/L.(Leukocyte and thrombocytopenia caused by splenic hyperfunction can be included in the group after partial embolization of the splenic artery or medication correction) (2) Blood biochemistry test (no albumin transfusion within 14 days before screening): Serum albumin ≥ 28g/L; Total serum bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 3 × ULN; Blood creatinine ≤ 1.5 x ULN or Cr clearance rate>50ml/min (3) International standardized ratio (INR) ≤ 2.3 or prothrombin time (PT) exceeding the range of normal control ≤ 6 (4) Urinary protein<2+(If urinary protein ≥ 2+, 24-hour urine protein quantification is required, and 24-hour urine protein quantification<1.0g can be included in the group).
  • 11. If suffering from hepatitis B virus (HBV) infection, it is necessary to be willing to receive antiviral treatment throughout the study period (according to the diagnostic and treatment guidelines, such as entecavir) and regularly monitor it; Hepatitis C virus (HCV) ribonucleic acid (RNA) positive subjects must receive antiviral treatment according to the diagnosis and treatment guidelines, and their liver function must be within CTCAE1 level elevation.
  • 12.Women with fertility: must agree to contraception from the signing of the informed consent form until 90 days after the last use of the study drug (whichever is longer). And the blood HCG test must be negative within 7 days before starting the study treatment; And it must be non lactation period

Who cannot join

  • If a subject meets any of the following conditions, they will not be allowed to enter this study:
  • Known hepatobiliary carcinoma, sarcoma like hepatocellular carcinoma, combined hepatocellular-cholangiocarcinoma，and fibrous layer cell carcinoma; Within 5 years or simultaneously suffering from other active malignant tumors other than hepatocellular carcinoma (excluding cured skin basal cell carcinoma and cervical carcinoma in situ).
  • There are uncontrollable extrahepatic metastases, such as lung and brain metastases (EHS).
  • Previously received local treatment, including therapeutic TACE, transarterial embolization (TAE), hepatic artery infusion chemotherapy (HAIC), transarterial radiation embolization (TARE), etc.
  • Participants who are preparing to undergo or have previously received organ or allogeneic bone marrow transplantation.
  • Participants who are currently accompanied by interstitial pneumonia or interstitial lung disease, or have a history of interstitial pneumonia or interstitial lung disease that requires hormone therapy in the past, or other pulmonary fibrosis, organized pneumonia (such as bronchiolitis obliterans), pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or subjects with evidence of active pneumonia or severe lung function impairment seen on chest computed tomography (CT) images during screening, are allowed to have radiation induced pneumonia in the radiation field; Active tuberculosis.
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  • Currently, there is active autoimmune disease or a history of autoimmune disease that may recur (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism [subjects that can be controlled only through hormone replacement therapy can be included]); Subjects with skin diseases that do not need systematic treatment, such as vitiligo, psoriasis, alopecia, controlled type I diabetes that receive insulin treatment, or childhood asthma that has completely alleviated without any intervention after adulthood can be included; Asthma subjects who require medical intervention with bronchodilators cannot be included.
  • Suffering from hypertension and unable to achieve good control through antihypertensive drug treatment (systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg) (based on the average BP reading obtained from ≥ 2 measurements), it is allowed to achieve the above parameters through the use of antihypertensive therapy; Previously experienced hypertensive crisis or hypertensive encephalopathy.
  • Participants with moderate to severe ascites with clinical symptoms who require therapeutic puncture or drainage, or whose Child Pugh score is greater than 7 (excluding those who only show a small amount of ascites on imaging but do not have clinical symptoms); Uncontrolled or moderate to equal amounts of pleural effusion and pericardial effusion.
  • There are clinical symptoms or diseases of the heart that cannot be well controlled, such as: (1) According to the standards of the New York Heart Association (NYHA), level II or above cardiac insufficiency or cardiac ultrasound examination: LVEF (left ventricular ejection fraction)<50%; (2) Unstable angina pectoris; (3) Have experienced myocardial infarction within one year prior to the start of the research treatment; (4) Clinically significant supraventricular or ventricular arrhythmias require treatment or intervention; (5) QTc>480ms (QTc interval is calculated using the Fridericia formula; if QTc is abnormal, it can be detected continuously three times every 2 minutes, and the average value is taken).
  • History of spontaneous rupture of liver tumors.
  • Individuals with a history of hepatic encephalopathy.
  • Congenital or acquired immune dysfunction in subjects (such as HIV infected individuals).
  • There have been incidents of thrombosis or embolism occurring within the first 6 months of treatment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc.
  • Participants with a history of gastrointestinal bleeding or a clear tendency towards gastrointestinal bleeding within 6 months prior to the start of the study treatment, such as those at risk of bleeding or severe esophageal and gastric varices, locally active gastrointestinal ulcer lesions, or continuous positive fecal occult blood, cannot be included in the study. (If fecal occult blood is positive during the baseline period, a follow-up examination is required. If the follow-up examination is still positive, gastroduodenoscopy (EGD) is required. If EGD indicates a risk of bleeding, esophageal and gastric varices/other gastrointestinal diseases cannot be included in the study.)
  • Within 6 months prior to the start of treatment, there have been abdominal fistulas, gastrointestinal perforation, or abdominal abscesses.
  • Severe, unhealed or cracked wounds, as well as active ulcers or untreated fractures.
  • Known genetic or acquired bleeding (such as coagulation dysfunction) or thrombotic tendencies, such as in hemophilia participants; Currently or recently (within 10 days prior to the start of research treatment), full dose oral or injection anticoagulants or thrombolytic drugs (prophylactic use of low-dose aspirin, low molecular weight heparin allowed) have been used for therapeutic purposes.
  • Major vascular diseases (such as aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) occur within 6 months prior to the start of the study treatment.
  • Severe infection within 4 weeks prior to the start of the study treatment, including but not limited to hospitalization due to complications of infection, bacteremia, or severe pneumonia; Oral or intravenous administration of therapeutic antibiotics within 2 weeks prior to the start of the study treatment (subjects who receive prophylactic antibiotics, such as preventing urinary tract infections or exacerbation of chronic obstructive pulmonary disease, are eligible to participate in the study).
  • It is known that the active ingredients and excipients contained in the investigational drugs (Adebelimumab, Apatinib) in this study have hypersensitivity reactions, or have a history of severe allergies to any other monoclonal antibodies or anti angiogenic targeted drugs.
  • Use immunosuppressive agents or systemic hormone therapy within 14 days prior to the start of the study to achieve immunosuppressive effects (dose>10mg/day prednisone or other therapeutic hormones).
  • Received attenuated live vaccine treatment within 28 days prior to the start of the study treatment, or expected to receive such vaccines during the treatment period with Adebrelimab or within 60 days after the last dose of Adebrelimab.
  • Received other experimental drug treatments within 28 days or 5 half-lives (whichever is longer) prior to the start of the study treatment.
  • According to the judgment of the researchers, the subjects may have other factors that may affect the research results or cause the study to be terminated midway, such as alcoholism, drug abuse, other serious illnesses (including mental illness) that require concurrent treatment, serious laboratory test abnormalities, and family or social factors that may affect the safety of the subjects.

Trial locations and contacts

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

Tao Li, Dr contact

+86-18560085138

Litao7706@163.com

China1 site, 1 recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

    Tao Li, 18560085138, Litao7706@163.com

    Dongxu Wang, 18560084836

    Recruiting

Other trials in China

About this study

Official title: An Open-Label, Single Arm Study to Evaluate the Efficacy and Safety of Adebrelimab Plus Apatinib as Adjuvant Therapy in Participants With Hepatocellular Carcinoma at High Risk of Recurrence After Surgical Resection

This is a single-center, single-arm, open-label clinical study to evaluate the efficacy and safety of Adebrelimab plus Apatinib as adjuvant therapy in hepatocellular carcinoma (HCC) participants who are at high risk of recurrence after curative resection.

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 participants with high risk of recurrence after curative resection.

Adebelimumab is a humanized anti-PD-L1 monoclonal antibody independently developed by Hengrui Pharmaceutical. It can specifically bind to PD-L1 molecules to block the PD-1/PD-L1 pathway that leads to tumor immune tolerance, reactivate the anti-tumor activity of the immune system, and achieve the goal of treating tumors. As of October 8, 2021, adebelimumab has conducted several clinical studies in various malignant tumor fields and has shown good anti-tumor efficacy and controllable safety.

Therefore, the investigators plan to conduct a prospective clinical study targeting HCC participants at high risk of postoperative recurrence, to demonstrate the efficacy and safety of postoperative adjuvant therapy with adebelimumab combined with apatinib. This study has the potential to provide efficient new treatment options for participants, which is of great significance for improving the survival rate and quality of life of liver cancer participants in general.

A mid-term analysis will be conducted on the recurrence free survival rate and survival rate, at 6 months after the enrollment of 30 participants.

Being tested
Adebrelimab + Apatinib
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • Adebrelimab + ApatinibDrug

    the first 6 months or 8 cycles: Adebrelimab 1200 mg, every 3 weeks； Apatinib 250 mg/day

    Maintenance phase： Adebrelimab 1200 mg, every 3 weeks, Maximum maintenance up to 2 years

Study groups in NCT06454578
Study groupRoleWhat they receive
Adebrelimab + ApatinibExperimentalNot described
Receives: Drug: Adebrelimab + Apatinib

What is being measured

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

  1. RFS Rate at 12 and 24 Months

    Recurrence-free survival rate at 12 and 24 Months

    Measured: up to 24 months

Secondary outcomes (3)

  1. overall survival

    Defined as the time from enrollment to death from any cause

    Measured: 3 years

  2. Time to Recurrence

    The time interval between liver resection and diagnosis of HCC recurrence

    Measured: up to 3 years

  3. recurrence-free survival

    Ratio of participants from first treatment to disease recurrence

    Measured: up to 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 posted12 Jun 2024
  2. Study start24 Jul 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionJun 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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06454578
Sponsor's protocol ID
KYLL-202401-002-1
Status last verified
Apr 2024
First submitted
6 Jun 2024
Last updated
1 Aug 2024
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 Adebrelimab + Apatinib in people with Carcinoma, Hepatocellular, run by Qilu Hospital of Shandong 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 15 inclusion and 25 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 1 Aug 2024. 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?

Contact Tao Li, Dr (+86-18560085138, Litao7706@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

RFS Rate at 12 and 24 Months (time frame: up to 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 NCT06454578.

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 Aug 2024.

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