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WithdrawnNCT05886257Updated Jun 2, 2023

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

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 Withdrawn at 1 site in China.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

Why this study was withdrawn
Protocol adjustment
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Hepatocellular Carcinoma

Keywords

  • Hepatocellular Carcinoma
  • Candonilimab Plus Bevacizumab
  • Atezolizumab Plus Bevacizumab
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

Browse Carcinoma studies →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Candonilimab Plus Bevacizumab

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

    Drug: Candonilimab · Drug: Bevacizumab

Interventions

  • DrugCandonilimab

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

  • DrugBevacizumab

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

06

What researchers measure

Primary outcomes

  1. ORR per RECIST 1.1

    Objective response rate per RECIST 1.1

    Time frame: 12 months

Secondary outcomes

  1. Overall survival (OS)

    OS is the length of time from the date of randomization until death from any cause.

    Time frame: 12 months

  2. 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

  3. 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

  4. PD-L1 Biomarker

    The blood specimen and needle biopsy specimen would be collected

    Time frame: 12 months

07

Study locations

1 site
  • Cancer Center Sun Yat-sen University
    Guangzhou, Guangdong 510060, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05886257
Lead sponsor
Shi Ming
Responsible party
Shi Ming (Proffessor, Sun Yat-sen University) — Sponsor-investigator
First posted
Jun 2, 2023
Start date
Dec 7, 2022
Primary completion
Mar 31, 2023
Completion
Mar 31, 2023
Last update
Jun 2, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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