Hepatocellular CarcinomaPhase 2NCT06196775
A Study of Cadonilimab Combined With AK112 as Second-line Therapy in Patients With Advanced Hepatocellular Carcinoma
A Phase 2 study testing AK104+AK112 in people with Hepatocellular Carcinoma, run by Harbin Medical University at 1 site in China.
Trial summary
To evaluate the efficacy and safety of cadonilimab combined with AK112 as second-line therapy in patients with advanced hepatocellular carcinoma. 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?
- AK104+AK112
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2024to 31 Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Histopathologically confirmed HCC
- Age 18-75 years old
- ECOG PS 0-1
- Child Pugh A-B7
- Patients who progressed on first-line standard system therapy (immunotherapy combined with Anti-angiogenesis targeting regimen) or with intolerable toxicity
- At least one measurable lesion (RECIST 1.1)
Show all 9Show fewer
- Enough organ and bone marrow function
- Expected survival time≥12 weeks
- Sign a written informed consent and be able to comply with the visit and related procedures required by the study protocol
Who cannot join
- Severe complications due to primary liver disease
- No prior systemic therapy for advanced or metastatic primary hepatocellular carcinoma
- Malignant diseases other than primary hepatocellular carcinoma were diagnosed within 5 years prior to first administration
- Previous treatment with drugs that synergistically inhibit T cell receptors (e.g., CTLA-4, OX-40, CD137)
- Autoimmune immune disease
- History of HIV
Show all 9Show fewer
- Prognent women
- The presence of any serious or uncontrolled systemic disease
- Medical history or evidence of disease that may interfere with the test results, prevent participants from participating fully in the study, abnormal treatment or laboratory test values, or other conditions that the investigator considers unsuitable for enrollment. The Investigator considers that there are other potential risks that are not suitable for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-arm, Single-center, Phase II Clinical Trial of Cadonilimab (Anti PD-1/CTLA-4) Combined With AK112 (Anti VEGF/PD-1) as Second-line Therapy in Patients With Unresectable Locally Advanced, Recurrent or Metastatic Hepatocellular Carcinoma
To evaluate the efficacy and safety of cadonilimab combined with AK112 as second-line therapy in patients with advanced hepatocellular carcinoma.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- AK104+AK112
- Keywords
- cadonilimab (anti PD-1/CTLA-4 bispecific antibody), AK112 ( anti VEGF/PD-1 bispecific antibody)
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK104+AK112Biological
Cadonilimab (AK104): 10mg/kg or 15mg/kg Q6W iv D8 (dose choosing depends on the outcome of the dose climb stage) AK112: 20mg/kg Q3W iv D1 Eligible patients will receive AK104 plus AK112 until disease progression or withdrawn ICF or death, whichever comes first.
| Study group | Role | What they receive |
|---|---|---|
| AK104+AK112 | Experimental | Not described Receives: Biological: AK104+AK112 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free-Survival
Defined as the time between signing the informed consent form to the disease progression (according to RECIST v1.1 criteria) or death due to any cause.
Measured: From the first drug administration up to two years
Secondary outcomes (4)
Objective Response Rate
Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1.
Measured: From the first drug administration up to two years
Disease control Rate
Defined as the proportion of patients who achieved complete response (CR), partial response (PR), and stable disease (SD) according to RECIST v1.1.
Measured: From the first drug administration up to two years
Overall survival
Defined as the time between the first dose to death due to any causes.
Measured: From the first drug administration up to two years
Incidence of Adverse Events
Use NCI-CTCAE version 5.0 for classification and grading.
Measured: From the first drug administration to within 90 days for the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start31 Jan 2024 (estimated)
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jan 2027 (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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqiao Zhang, Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06196775
- Sponsor's protocol ID
- AK104-IIT-042
- Status last verified
- Dec 2023
- First submitted
- 25 Dec 2023
- Last updated
- 9 Jan 2024
- 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 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Single-center, Phase II Clinical Trial of Cadonilimab (Anti PD-1/CTLA-4) Combined With AK112 (Anti VEGF/PD-1) as Second-line Therapy in Patients With Unresectable Locally Advanced, Recurrent or Metastatic Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT06196775
- Acronym / sponsor ID
- AK104-IIT-042
- Conditions
- Hepatocellular Carcinoma
- Keywords
- cadonilimab (anti PD-1/CTLA-4 bispecific antibody), AK112 ( anti VEGF/PD-1 bispecific antibody)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Study start
- 31 Jan 2024 (estimated)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 9 Jan 2024 (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 evaluate the efficacy and safety of cadonilimab combined with AK112 as second-line therapy in patients with advanced 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 |
|---|---|---|
| AK104+AK112 | Experimental | Biological: AK104+AK112 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histopathologically confirmed HCC
- Age 18-75 years old
- ECOG PS 0-1
- Child Pugh A-B7
- Patients who progressed on first-line standard system therapy (immunotherapy combined with Anti-angiogenesis targeting regimen) or with intolerable toxicity
Key exclusion criteria (9 listed)
- Severe complications due to primary liver disease
- No prior systemic therapy for advanced or metastatic primary hepatocellular carcinoma
- Malignant diseases other than primary hepatocellular carcinoma were diagnosed within 5 years prior to first administration
- Previous treatment with drugs that synergistically inhibit T cell receptors (e.g., CTLA-4, OX-40, CD137)
- Autoimmune immune disease
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 |
|---|---|---|
| AK104+AK112Cadonilimab (AK104): 10mg/kg or 15mg/kg Q6W iv D8 (dose choosing depends on the outcome of the dose climb stage) AK112: 20mg/kg Q3W iv D1 Eligible patients will receive AK104 plus AK112 until disease progression or withdrawn ICF or death, whichever comes first. | Biological | AK104+AK112 |
Primary outcome
Progression-Free-Survival
Time frame: From the first drug administration up to two years
Defined as the time between signing the informed consent form to the disease progression (according to RECIST v1.1 criteria) or death due to any cause.
4 secondary outcomes
Objective Response Rate
Time frame: From the first drug administration up to two years
Disease control Rate
Time frame: From the first drug administration up to two years
Overall survival
Time frame: From the first drug administration up to two years
Incidence of Adverse Events
Time frame: From the first drug administration to within 90 days for the last dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
Related trials for Hepatocellular Carcinoma
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
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.
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 AK104+AK112 in people with Hepatocellular Carcinoma, run by Harbin Medical University 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 9 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: opening soon, as of the sponsor's last update on 9 Jan 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanqiao Zhang, PhD. (13845120210, yanqiaozhang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free-Survival (time frame: From the first drug administration up to two years). 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 9 Jan 2024.