Candonilimab Plus Bevacizumab for Patients With Advanced HCC Who Progressed on A+T

Trial Title: Candonilimab Plus Bevacizumab for Patients With Advanced HCC Who Progressed on A+T

NCT ID: NCT05760599

Condition: Hepatocellular Carcinoma

Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Bevacizumab

Conditions: Keywords:
Hepatocellular Carcinoma
Candonilimab Plus Bevacizumab
Atezolizumab Plus Bevacizumab

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Candonilimab
Description: 10mg/kg, iv.drip, every 3 week
Arm group label: Candonilimab Plus Bevacizumab

Intervention type: Drug
Intervention name: Bevacizumab
Description: 15mg/kg, iv.drip, every 3 week
Arm group label: Candonilimab Plus Bevacizumab

Summary: To explore the efficacy and safety of candonilimab plus bevacizumab for patients with advanced hepatocellular carcinoma who progressed on atezolizumab plus bevacizumab.

Detailed description: Atezolizumab plus bevacizumab is the first-line treatent for patients with advanced hepatocellular carcinoma. However, the second-line treatment is absent for patients who progressed on atezolizumab plus bevacizumab. Candonilimab is a humanized bisspecific monoclonal antibody against PD-1/ CTLA-4 IgG1. Candonilimab plus lenvatinib showed strong anti-tumor effect, with objective response of 44%. This single-arm, prospective, phase 2 trial is to explore the efficacy and safety of candonilimab plus bevacizumab for patients with advanced hepatocellular carcinoma who progressed on atezolizumab plus bevacizumab.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL) - Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria. - Barcelona clinic liver cancer-stage C - Eastern Cooperative Oncology Group performance status of 0 to 2 - Patients have received atezolizumab plus bevacizumab and the tumor have progressed. Patients have not received other treatmets except for the atezolizumab plus bevacizumab. - No Cirrhosis or cirrhotic status of Child-Pugh class A only - Not amendable to surgical resection ,local ablative therapy and any other cured treatment. - The following laboratory parameters: Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) >1,500/mm3 • Ability to understand the protocol and to agree to and sign a written informed consent document Exclusion Criteria: - Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy - Known history of HIV - History of organ allograft - Known or suspected allergy to the investigational agents or any agent given in association with this trial. - Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy - Evidence of bleeding diathesis. - Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. - Known central nervous system tumors including metastatic brain disease

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Cancer Center Sun Yat-sen University

Address:
City: Guangzhou
Zip: 510060
Country: China

Status: Recruiting

Contact:
Last name: Ming Shi, MD

Phone: 8620-87343115
Email: shiming@mail.sysu.edu.cn

Start date: February 27, 2023

Completion date: July 1, 2024

Lead sponsor:
Agency: Shi Ming
Agency class: Other

Source: Sun Yat-sen University

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

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05760599