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

NCT05760599 | Unknown Phase 2 DMC

• 1 other identifier: S104B
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; Candonilimab Plus Bevacizumab; Atezolizumab Plus Bevacizumab

Outcome Measures

Primary Outcomes (1)

• DCR per RECIST 1.1

  DCR （Disease Control Rate） include complete response, partial response and stable Disease per RECIST 1.1

  12 months

Secondary Outcomes (5)

• Overall survival (OS)

  12 months

• Progression free survival (PFS)

  12 months

• ORR per RECIST 1.1

  12 months

• Adverse events

  30 days

• Biomarkers such as PD-L1 expression

  12 months

Study Arms (1)

Candonilimab Plus Bevacizumab

EXPERIMENTAL

Candonilimab 10mg/kg, Bevacizumab 15mg/kg, every 3 week

Drug: Candonilimab; Drug: Bevacizumab

Interventions

Candonilimab DRUG

10mg/kg, iv.drip, every 3 week

Candonilimab Plus Bevacizumab

Bevacizumab DRUG

15mg/kg, iv.drip, every 3 week

Candonilimab Plus Bevacizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shi Ming: lead

Study Sites (1)

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Proffessor

Study Record Dates

• First Submitted: February 26, 2023
• First Posted: March 8, 2023
• Study Start: February 27, 2023
• Primary Completion: January 1, 2024
• Study Completion: July 1, 2024
• Last Updated: March 8, 2023

Record last verified: 2023-02

Locations

CN (1)