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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-01

Study Completion Date

2029-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hepatocellular Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Anti-PD-1/PD-L1 antibodies and Anti-VEGF combination

Anti-PD-1/PD-L1 antibodies

Intervention Type DRUG

Anti-PD-1/PD-L1 Intravenous injection for at least 6 months

Anti-VEGF

Intervention Type DRUG

Anti-VEGF Intravenous injection for at least 6 months

Interventions

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Anti-PD-1/PD-L1 antibodies

Anti-PD-1/PD-L1 Intravenous injection for at least 6 months

Intervention Type DRUG

Anti-VEGF

Anti-VEGF Intravenous injection for at least 6 months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. ≥18 years old, male or female
2. Advanced hepatocellular carcinoma (cannot be removed or metastasized) diagnosed clinically or pathologically, at least one measurable lesion without local treatment, 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 a medically-accepted contraceptive (such as an intrauterine device, contraceptive or condom) during the study period and within 3 months after the end of the study treatment period.

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, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, thyroid Hyperfunction; patients with vitiligo; complete remission of asthma in childhood, can be included without any intervention after adulthood; asthma patients who require bronchodilators for medical intervention cannot be included);
2. The patient is using immunosuppressive agents or systemic hormonal therapy to achieve immunosuppressive purposes (agents amount \> 10 mg / day of prednisone or other 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 tendency within 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 the results of the study or lead to the termination of the study, such as alcohol abuse, drug abuse, other serious diseases (including mental illness) requiring combined treatment, and serious laboratory abnormalities.#with family or social factors, it will affect the safety of patients.
7. Liver tumor burden greater than 50% of the total liver volume, or patients who have previously undergone liver transplantation;Known for a history of central nervous system metastasis or hepatic encephalopathy;Severe allergic reactions to other monoclonal antibodies;

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No