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

Hepatocellular Carcinoma Clinical Trial

Official title:

Candonilimab Plus Bevacizumab as Second-line Treatment for Patients With Advanced Hepatocellular Carcinoma Who Progressed on Atezolizumab Plus Bevacizumab: a Single Arm, Phase 2 Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05760599
• Other study ID #: S104B
• Status: Recruiting
• Phase: Phase 2
• Start date: February 27, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: February 2023
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Candonilimab
10mg/kg, iv.drip, every 3 week
• Bevacizumab
15mg/kg, iv.drip, every 3 week

Locations

Country	Name	City	State
China	Cancer Center Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shi Ming

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DCR per RECIST 1.1	DCR (Disease Control Rate) include complete response, partial response and stable Disease per RECIST 1.1	12 months
Secondary	Overall survival (OS)	OS is the length of time from the date of randomization until death from any cause.	12 months
Secondary	Progression free survival (PFS)	PFS is defined as the time from the date of randomization to the date of the first objectively documented tumor progression or death due to any cause.	12 months
Secondary	ORR per RECIST 1.1	Objective response rate (complete response+partial response) per RECIST 1.1	12 months
Secondary	Adverse events	Safety will be evaluated according to the NCI CTCAE Version 4.03. All observations pertinent to the safety of the study medication will be recorded on the CRF and included in the final report.	30 days
Secondary	Biomarkers such as PD-L1 expression	The blood specimen and needle biopsy specimen would be collected	12 months