A Phase 2 interventional study of Candonilimab and Bevacizumab in Hepatocellular Carcinoma, sponsored by Shi Ming. Withdrawn at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-06-02.
Sponsored by Shi Ming · Phase 2, Interventional, and Treatment
To explore the efficacy and safety of candonilimab plus bevacizumab for patients with advanced hepatocellular carcinoma who progressed on atezolizumab plus bevacizumab.
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
Browse Carcinoma studies →Shi Ming is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
Candonilimab 10mg/kg, Bevacizumab 15mg/kg, every 3 week
Drug: Candonilimab · Drug: Bevacizumab
10mg/kg, iv.drip, every 3 week
15mg/kg, iv.drip, every 3 week
ORR per RECIST 1.1
Objective response rate per RECIST 1.1
Time frame: 12 months
Overall survival (OS)
OS is the length of time from the date of randomization until death from any cause.
Time frame: 12 months
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.
Time frame: 12 months
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.
Time frame: 30 days
PD-L1 Biomarker
The blood specimen and needle biopsy specimen would be collected
Time frame: 12 months
This study is withdrawn, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Shi Ming