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

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

NCT ID: NCT06537908

Condition: Hepatocellular Carcinoma

Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Antibodies

Conditions: Keywords:
Hepatocellular Carcinoma
Anti-PD-1 antibody
Anti-PD-L1 antibody
Anti-VEGF

Study type: Observational [Patient Registry]

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Drug
Intervention name: Anti-PD-1/PD-L1 antibodies
Description: Anti-PD-1/PD-L1 Intravenous injection for at least 6 months
Arm group label: Anti-PD-1/PD-L1 antibodies and Anti-VEGF combination

Intervention type: Drug
Intervention name: Anti-VEGF
Description: Anti-VEGF Intravenous injection for at least 6 months
Arm group label: Anti-PD-1/PD-L1 antibodies and Anti-VEGF combination

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.

Detailed 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.

Criteria for eligibility:

Study pop:
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

Sampling method: Probability Sample
Criteria:
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;

Gender: All

Minimum age: 18 Years

Maximum age: 90 Years

Healthy volunteers: No

Locations:

Facility:
Name: Zhongshan Hospital Fudan university

Address:
City: Shanghai
Country: China

Status: Recruiting

Contact:
Last name: Wenxin Xu

Phone: 2164041990
Email: 22211210052@m.fudan.edu.cn

Start date: August 1, 2024

Completion date: December 31, 2029

Lead sponsor:
Agency: Shanghai Zhongshan Hospital
Agency class: Other

Source: Shanghai Zhongshan Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06537908