Hepatocellular CarcinomaPhase 2NCT05760599
Candonilimab Plus Bevacizumab for Patients With Advanced HCC Who Progressed on A+T
A Phase 2 study testing Candonilimab and Bevacizumab in people with Hepatocellular Carcinoma, run by Shi Ming at 1 site in China.
Trial summary
To explore the efficacy and safety of candonilimab plus bevacizumab for patients with advanced hepatocellular carcinoma who progressed on atezolizumab plus bevacizumab. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Candonilimab and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 27 Feb 2023to 1 Jul 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, 510060
Ming Shi, MD, 8620-87343115, shiming@mail.sysu.edu.cn
About this study
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
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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Candonilimab, Bevacizumab
- Keywords
- Hepatocellular Carcinoma, Candonilimab Plus Bevacizumab, Atezolizumab Plus Bevacizumab
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CandonilimabDrug
10mg/kg, iv.drip, every 3 week
BevacizumabDrug
15mg/kg, iv.drip, every 3 week
| Study group | Role | What they receive |
|---|---|---|
| Candonilimab Plus Bevacizumab | Experimental | Candonilimab 10mg/kg, Bevacizumab 15mg/kg, every 3 week Receives: Drug: Candonilimab; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
DCR per RECIST 1.1
DCR （Disease Control Rate） include complete response, partial response and stable Disease per RECIST 1.1
Measured: 12 months
Secondary outcomes (5)
Overall survival (OS)
OS is the length of time from the date of randomization until death from any cause.
Measured: 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.
Measured: 12 months
ORR per RECIST 1.1
Objective response rate (complete response+partial response) per RECIST 1.1
Measured: 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.
Measured: 30 days
Biomarkers such as PD-L1 expression
The blood specimen and needle biopsy specimen would be collected
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start27 Feb 2023
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shi Ming
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shi Ming, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05760599
- Sponsor's protocol ID
- S104B
- Status last verified
- Feb 2023
- First submitted
- 26 Feb 2023
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05760599
- Acronym / sponsor ID
- S104B
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, Candonilimab Plus Bevacizumab, Atezolizumab Plus Bevacizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shi MingUniversity, hospital or other
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 8 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To explore the efficacy and safety of candonilimab plus bevacizumab for patients with advanced hepatocellular carcinoma who progressed on atezolizumab plus bevacizumab.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Candonilimab Plus Bevacizumab | Experimental | Drug: Candonilimab, Drug: BevacizumabCandonilimab 10mg/kg, Bevacizumab 15mg/kg, every 3 week |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Candonilimab10mg/kg, iv.drip, every 3 week | Drug | Candonilimab Plus Bevacizumab |
| Bevacizumab15mg/kg, iv.drip, every 3 week | Drug | Candonilimab Plus Bevacizumab |
Primary outcome
DCR per RECIST 1.1
Time frame: 12 months
DCR （Disease Control Rate） include complete response, partial response and stable Disease per RECIST 1.1
5 secondary outcomes
Overall survival (OS)
Time frame: 12 months
Progression free survival (PFS)
Time frame: 12 months
ORR per RECIST 1.1
Time frame: 12 months
Adverse events
Time frame: 30 days
Biomarkers such as PD-L1 expression
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Candonilimab and Bevacizumab in people with Hepatocellular Carcinoma, run by Shi Ming at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DCR per RECIST 1.1 (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2023.