Hepatocellular CarcinomaPhase 2NCT05925413
Cadonilimab Plus TACE in Patients With Intermediate-stage Unresectable Hepatocellular Carcinoma
A Phase 2 study testing Cadonilimab+TACE in people with Hepatocellular Carcinoma, run by Eastern Hepatobiliary Surgery Hospital at 1 site in China.
Trial summary
Cadonilimab is a first-in-class bispecific, humanized IgG1 antibody targeting PD-1 and CTLA-4, which has the potential to boost immune surveillance in tumors. The goal of this clinical trial is to evaluated the efficacy and safety of cadonilimab combined with TACE in patients with intermediate-stage unresectable… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Cadonilimab+TACE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteChina
- Study dates
- 24 Apr 2023to 30 Jul 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- written informed consent signed prior to enrolment.
- age > 18 years, both sexes
- patients with histologically or pathologically confirmed intermediate hepatocellular carcinoma; BCLC stage B or CNLC stage II
- no previous antitumor therapy
- Child-Pugh A or B7.
- with measurable lesions (≥10 mm long diameter on CT scan for non-lymph node lesions and ≥15 mm short diameter on CT scan for lymph node lesions according to RECIST 1.1 criteria).
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- ECOG PS score: 0 to 1.
- expected survival of >12 weeks.
- Adequate organ function
Who cannot join
- BCLC C stage HCC
- In combined with severe heart, lung, kidney or other important organ dysfunction, or combined with serious infection or other serious associated diseases, that cannot tolerate treatment (> CTCAE Version 5.0 adverse events of grade 2).
- With uncontrolled hepatitis B (HBV-DNA>2000 IU/ml and elevated ALT).
- Multi-nodules hepatocellular carcinoma beyond hemi-hepatic range.
- Patients with tumor thrombus reaches or exceeds the portal vein.
- History of other malignancies.
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- History of allergic reactions to related drugs.
- History of organ transplantation.
- Pregnant women, nursing mothers.
- Patients have other factors that may interfere with patient enrollment and assessment results.
- Refuse follow-up as required by this study protocol and refuse to sign informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site
Eastern hepatobilliary surgery hospital
Shanghai, Shanghai Municipality, 200438
About this study
Official title: Cadonilimab Combined With Transarterial Chemoembolization (TACE) in Patients With Intermediate-stage Unresectable Hepatocellular Carcinoma: A Single Center, Single Arm, Phase II Trial
Cadonilimab is a first-in-class bispecific, humanized IgG1 antibody targeting PD-1 and CTLA-4, which has the potential to boost immune surveillance in tumors. The goal of this clinical trial is to evaluated the efficacy and safety of cadonilimab combined with TACE in patients with intermediate-stage unresectable hepatocellular carcinoma.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Cadonilimab+TACE
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cadonilimab+TACEDrug
Cadonilimab: 15mg/kg Q3W Day1 Select the best TACE treatment strategy. Traditional TACE (cTACE) or DEB-TACE can be selected. TACE treatment can be continued as needed based on disease control. The combination of cadonilimab is given 3 to 7 days after the first TACE treatment, and the subsequent administration of cardonilizumab is given once every 3 weeks, if the time overlaps with TACE treatment, it is generally administered 3 to 7 days after TACE treatment. Treatment was discontinued until intolerable toxicity, death, withdrawal of informed consent, initiation of a new antitumor therapy, or other reason specified in the protocol, whichever occurs first. Patients in this study received cadonilimab for up to 24 months.
| Study group | Role | What they receive |
|---|---|---|
| Cadonilimab+TACE | Experimental | Cadonilimab (15mg/kg Q3W D1)+TACE Receives: Drug: Cadonilimab+TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
ORR is defined as the percentage of participants who have a confirmed complete response or partial response according to RECIST 1.1.
Measured: Up to 1 year
Secondary outcomes (3)
Progression free survival (PFS)
PFS is defined as the time from enrollment of the trial to the first documented disease progression or death due to any cause.
Measured: Up to two years
Overall survival (OS)
The duration from the date of recruitment to the date of death from any cause.
Measured: Up to two years
Adverse events (safety)
Adverse events (safety ) will be evaluated according to the NCI CTCAE Version 5.0.The number and severity of treatment-related side effects, including AE and SAE, will be recorded during treatment.
Measured: Up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start24 Apr 2023
- Primary completion30 Jul 2024 (estimated)
- Study completion30 Jul 2025 (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
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Hepatobiliary Surgery Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen Feng, Eastern Hepatobiliary Surgery Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05925413
- Sponsor's protocol ID
- EHBHKY2023-H006-P001
- Status last verified
- Jun 2023
- First submitted
- 21 Jun 2023
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cadonilimab Combined With Transarterial Chemoembolization (TACE) in Patients With Intermediate-stage Unresectable Hepatocellular Carcinoma: A Single Center, Single Arm, Phase II Trial
- ClinicalTrials.gov ID
- NCT05925413
- Acronym / sponsor ID
- EHBHKY2023-H006-P001
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Eastern Hepatobiliary Surgery HospitalUniversity, hospital or other
- Study start
- 24 Apr 2023 (actual)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 29 Jun 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.
Cadonilimab is a first-in-class bispecific, humanized IgG1 antibody targeting PD-1 and CTLA-4, which has the potential to boost immune surveillance in tumors. The goal of this clinical trial is to evaluated the efficacy and safety of cadonilimab combined with TACE in patients with intermediate-stage unresectable hepatocellular carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cadonilimab+TACE | Experimental | Drug: Cadonilimab+TACECadonilimab (15mg/kg Q3W D1)+TACE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- written informed consent signed prior to enrolment.
- age > 18 years, both sexes
- patients with histologically or pathologically confirmed intermediate hepatocellular carcinoma; BCLC stage B or CNLC stage II
- no previous antitumor therapy
- Child-Pugh A or B7.
Key exclusion criteria (11 listed)
- BCLC C stage HCC
- In combined with severe heart, lung, kidney or other important organ dysfunction, or combined with serious infection or other serious associated diseases, that cannot tolerate treatment (> CTCAE Version 5.0 adverse events of grade 2).
- With uncontrolled hepatitis B (HBV-DNA>2000 IU/ml and elevated ALT).
- Multi-nodules hepatocellular carcinoma beyond hemi-hepatic range.
- Patients with tumor thrombus reaches or exceeds the portal vein.
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 |
|---|---|---|
| Cadonilimab+TACECadonilimab: 15mg/kg Q3W Day1 Select the best TACE treatment strategy. Traditional TACE (cTACE) or DEB-TACE can be selected. TACE treatment can be continued as needed based on disease control. The combination of cadonilimab is given 3 to 7 days after the first TACE treatment, and the subsequent administration of cardonilizumab is given once every 3 weeks, if the time overlaps with TACE treatment, it is generally administered 3 to 7 days after TACE treatment. Treatment was discontinued until intolerable toxicity, death, withdrawal of informed consent, initiation of a new antitumor therapy, or other reason specified in the protocol, whichever occurs first. Patients in this study received cadonilimab for up to 24 months. | Drug | Cadonilimab+TACE |
Primary outcome
Objective response rate (ORR)
Time frame: Up to 1 year
ORR is defined as the percentage of participants who have a confirmed complete response or partial response according to RECIST 1.1.
3 secondary outcomes
Progression free survival (PFS)
Time frame: Up to two years
Overall survival (OS)
Time frame: Up to two years
Adverse events (safety)
Time frame: Up to two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cadonilimab+TACE in people with Hepatocellular Carcinoma, run by Eastern Hepatobiliary Surgery Hospital 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 9 inclusion and 11 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 29 Jun 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: Up to 1 year). 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 29 Jun 2023.