Study Stopped
Protocol adjustment
Candonilimab Plus Bevacizumab for Patients With Advanced HCC Who Progressed on A+T
1 other identifier
interventional
N/A
1 country
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2022
Shorter than P25 for phase_2 hepatocellular-carcinoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 6, 2022
CompletedStudy Start
First participant enrolled
December 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2023
CompletedFirst Posted
Study publicly available on registry
June 2, 2023
CompletedJune 2, 2023
December 1, 2022
4 months
December 6, 2022
June 1, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ORR per RECIST 1.1
Objective response rate per RECIST 1.1
12 months
Secondary Outcomes (4)
Overall survival (OS)
12 months
Progression free survival (PFS)
12 months
Adverse events
30 days
PD-L1 Biomarker
12 months
Study Arms (1)
Candonilimab Plus Bevacizumab
EXPERIMENTALCandonilimab 10mg/kg, Bevacizumab 15mg/kg, every 3 week
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shi Minglead
Study Sites (1)
Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, 510060, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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
December 6, 2022
First Posted
June 2, 2023
Study Start
December 7, 2022
Primary Completion
March 31, 2023
Study Completion
March 31, 2023
Last Updated
June 2, 2023
Record last verified: 2022-12