Anti-PD-1/PD-L1 Antibodies Plus Anti-VEGF Antibody Treatment in Patients With Advanced-Stage HCC

Last updated: July 31, 2024
Sponsor: Shanghai Zhongshan Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Liver Cancer

Cancer/tumors

Liver Disorders

Treatment

Anti-PD-1/PD-L1 antibodies

Anti-VEGF

Clinical Study ID

NCT06537908
B2024-104
  • Ages 18-90
  • All Genders

Study Summary

This study is being done to analyze the safety, tolerability, and efficacy of treatment using combination of anti-VEGF and anti-PD-1/PDL1 antibodies for patients with advanced hepatocellular carcinoma.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. ≥18 years old, male or female

  2. Advanced hepatocellular carcinoma (cannot be removed or metastasized) diagnosedclinically or pathologically, at least one measurable lesion without localtreatment, Child-Pugh A ;Barcelona Clinic Liver Cancer(BCLC) staging is stage B or C

  3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1

  4. Patient has given written informed consent.

  5. The function of important organs meets the requirements

  6. Expected survival ≥12 weeks

  7. Non-surgical sterilization or women of childbearing age need to use amedically-accepted contraceptive (such as an intrauterine device, contraceptive orcondom) during the study period and within 3 months after the end of the studytreatment period.

Exclusion

Exclusion Criteria:

  1. The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitialpneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis,nephritis, thyroid Hyperfunction; patients with vitiligo; complete remission ofasthma in childhood, can be included without any intervention after adulthood;asthma patients who require bronchodilators for medical intervention cannot beincluded);

  2. The patient is using immunosuppressive agents or systemic hormonal therapy toachieve immunosuppressive purposes (agents amount > 10 mg / day of prednisone orother therapeutic hormones), and continue to use within 2 weeks before enrollment;

  3. Have clinical symptoms or disease that are not well controlled;

  4. Significant clinically significant bleeding symptoms or a clear bleeding tendencywithin 3 months prior to randomization;

  5. Arterial/venous thrombosis in the first 6 months of randomization

  6. According to the investigator, the patient has other factors that may affect theresults of the study or lead to the termination of the study, such as alcohol abuse,drug abuse, other serious diseases (including mental illness) requiring combinedtreatment, and serious laboratory abnormalities.#with family or social factors, itwill affect the safety of patients.

  7. Liver tumor burden greater than 50% of the total liver volume, or patients who havepreviously undergone liver transplantation;Known for a history of central nervoussystem metastasis or hepatic encephalopathy;Severe allergic reactions to othermonoclonal antibodies;

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Anti-PD-1/PD-L1 antibodies
Phase:
Study Start date:
August 01, 2024
Estimated Completion Date:
December 31, 2029

Study Description

This is a study of combination anti-PD-1/PD-L1 antibodies and anti-VEGF for adult patients (≥18) with advanced hepatocellular carcinoma.

Anti-VEGF (including Avastin, IBI305 etc.) is designed to block a protein called vascular endothelial growth factor, therefore blocking the blood supply that feeds the tumor. Also, Anti-VEGF has recently been shown to play a key role regulating cancer cell proliferation trough epigenetic pathway.

Anti-PD-1/PD-L1 antibodies (including pembrolizumeb, nivolumab, sintilimab, toripalimab, camrelizumeb, tislelizumab and atezolizumab etc.) are given intravenously at assigned dose. Treatment may continue until disease progression, intolerable toxicity, or consent withdrawal.

This study is aimed to evaluate the safety and efficacy of the combination of anti-VEGF and PD-1/PD-L1 mAb in unresectable late-stage HCC patients.

Connect with a study center

  • Zhongshan Hospital Fudan university

    Shanghai,
    China

    Active - Recruiting

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