Advanced Hepatocellular Carcinoma That Has Failed at Least One Prior Systemic TherapyPhase 1NCT05644379
A Study Evaluating Cadonilimab Injection in Combination With Regorafenib for the Advanced Hepatocellular Carcinoma
A Phase 1 study testing Cadonilimab Injection and Regorafenib in people with Advanced Hepatocellular Carcinoma That Has Failed at Least One Prior Systemic Therapy, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
To evaluate the efficacy and safety of Cadonilimab Injection in combination with Regorafenib in the treatment of intermediate to advanced hepatocellular carcinoma that has failed at least one prior systemic therapy . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Hepatocellular Carcinoma That Has Failed at Least One Prior Systemic Therapy
- What is being tested?
- Cadonilimab Injection and Regorafenib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 24 Nov 2022to Nov 2026
- Phase
- Phase 1
- 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
- written informed consent signed prior to enrolment.
- age > 18 years, both sexes
- patients with histologically or pathologically confirmed intermediate to advanced hepatocellular carcinoma.
- intermediate to advanced HCC previously treated with anti-PD-1/PD-L1 combined with anti-vascular targeting agents for HCC, with disease progression.
- Child-Pugh A or B.
- 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).
Show all 30Show fewer
- ECOG PS score: 0 to 1.
- expected survival of >12 weeks.
- function of vital organs in accordance with the following requirements (excluding the use of any blood components and cell growth factors within 14 days).
- 1) Blood count. Neutrophils ≥ 1.5 x 109/L Platelet count ≥ 60×109/L haemoglobin ≥ 90 g/L. 2) Liver and kidney function. Serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance ≥ 50 ml/min (Cockcroft-Gault formula).
- total bilirubin (TBIL) ≤ 3 times the upper limit of normal (ULN) Glutamic aminotransferase (AST) or glutamic aminotransferase (ALT) levels ≤ 10 times the upper limit of normal (ULN); urine protein < 2+; if urine protein ≥ 2+, 24-hour urine protein quantification must show ≤ 1 g of protein.
- 10. normal coagulation function, no active bleeding or thrombotic disease
- International normalised ratio INR ≤ 1.5 x ULN.
- partial thromboplastin time APTT ≤ 1.5 x ULN.
- prothrombin time PT ≤ 1.5 x ULN. 11. Female patients who are non-surgically sterilised or of childbearing age are required to use a medically approved contraceptive (e.g. IUD, pill or condom) during and for 3 months after the end of the study treatment period; female patients of childbearing age who are non-surgically sterilised must have a negative serum or urine HCG test within 7 days prior to study entry; and must be non-lactating; male patients who are non-surgically sterilised or of childbearing age Patients, need to agree to use a medically approved form of contraception with their spouse during and for 3 months after the end of the study treatment period.
- 12. The subject is voluntarily enrolled in the study, is compliant and cooperates with safety and survival follow-up Exclusion criteria： Exclusion criteria Patients with any of the following are not eligible for enrollment in this study.
- Subjects with previous or concurrent other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix).
- the subject has received previous immunotherapy other than anti-PD-1/PD-L1 monoclonal antibody; the subject is known to have a previous allergy to macromolecular protein agents, or is known to be allergic to the components of the drug applied.
- The subject has any active autoimmune disease or history of autoimmune disease (e.g. the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enterocolitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism, previous thyroid surgery cannot be included; the subject has vitiligo or has complete remission of asthma in childhood and in adulthood (subjects who do not require any intervention can be included; subjects with asthma requiring medical intervention with bronchodilators cannot be included).
- subjects who are on immunosuppressive, or systemic, or absorbable topical hormone therapy for immunosuppressive purposes (doses >10 mg/day of prednisone or other isotonic hormones) and who continue to use them within 2 weeks prior to enrolment
- have clinically symptomatic ascites or pleural effusion requiring therapeutic puncture or requiring frequent drainage of ascites (≥1 time/month)
- subjects with clinically symptomatic cardiac conditions or diseases that are not well controlled, such as (1) NYHA class 2 or higher heart failure (2) unstable angina pectoris (3) previous myocardial infarction within 1 year (4) patients with clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention
- subjects with active infection or unexplained fever >38.5 degrees during screening and prior to the first dose (subjects with fever arising from a tumour may be enrolled, as judged by the investigator)
- patients with previous and current objective evidence of a history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, or severely impaired lung function
- subjects with congenital or acquired immune deficiency, e.g. HIV infection
- subjects who have received a live vaccine less than 4 weeks prior to study drug administration or possibly during the study period
- subjects with a known history of psychotropic substance abuse, alcoholism or drug use
- patients who are unable to administer the drug orally
- have received herbal or proprietary Chinese medicine with an anti-tumour indication within 2 weeks prior to the first dose .
- 14 Patients who, in the opinion of the investigator, should be excluded from the study, for example, subjects who, in the judgment of the investigator, have other factors that may force the study to be terminated, e.g., other serious illnesses (including psychiatric illnesses) requiring comorbid treatment, severe fundic esophageal varices, serious laboratory test abnormalities, accompanying family or social factors that would compromise the safety of the subject, or the collection of data and samples.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, 300308
About this study
Official title: An Open, Single-arm, Single-centre Clinical Study Evaluating Cadonilimab Injection in Combination With Regorafenib for the Treatment of Intermediate to Advanced Hepatocellular Carcinoma That Has Failed at Least One Prior Systemic Therapy
To evaluate the efficacy and safety of Cadonilimab Injection in combination with Regorafenib in the treatment of intermediate to advanced hepatocellular carcinoma that has failed at least one prior systemic therapy .
Read the detailed description
An open, single-arm, single-centre clinical study evaluating Cadonilimab Injection in combination with Regorafenib for the treatment of intermediate to advanced hepatocellular carcinoma that has failed at least one prior systemic therapy.
- Being tested
- Cadonilimab Injection, Regorafenib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cadonilimab InjectionDrug
Also called AK104
Cadonilimab Injection, 6mg/kg, intravenous drip ,q2w,
RegorafenibDrug
Regorafenib 80mg, po, orally once daily
| Study group | Role | What they receive |
|---|---|---|
| Cadonilimab Injection in combination with Regorafenib | Experimental | Cadonilimab Injection in combination with Regorafenib Receives: Drug: Cadonilimab Injection; Drug: Regorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate ( ORR)
Defined as proportion of patients who have a best response of CR or PR
Measured: up to 1 years
Overall survival (OS)
OS is defined as the time from date of neoadjuvant treatment start to the date of death from any cause or to the date of last follow-up if patients are alive. If a patient is alive by the time of final analysis, the patient will be censored at the last follow-up date.
Measured: up to 3 years
Progress Free Survival （PFS）
Defined as the time from enrollment to disease progression or death (whichever occurs first)
Measured: up to 3 years
Adverse Events (AEs)
Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start24 Nov 2022
- Primary completion1 Nov 2025
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Hepatocellular Carcinoma That Has Failed at Least One Prior Systemic TherapyStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05644379
- Sponsor's protocol ID
- AK104-IIT-C-N1-0004
- Status last verified
- Feb 2026
- First submitted
- 30 Nov 2022
- Last updated
- 9 Feb 2026
- 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 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Single-arm, Single-centre Clinical Study Evaluating Cadonilimab Injection in Combination With Regorafenib for the Treatment of Intermediate to Advanced Hepatocellular Carcinoma That Has Failed at Least One Prior Systemic Therapy
- ClinicalTrials.gov ID
- NCT05644379
- Acronym / sponsor ID
- AK104-IIT-C-N1-0004
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 24 Nov 2022 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- Nov 2026 (estimated)
- First posted
- 9 Dec 2022 (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 Injection in combination with Regorafenib in the treatment of intermediate to advanced hepatocellular carcinoma that has failed at least one prior systemic therapy .
Detailed description
An open, single-arm, single-centre clinical study evaluating Cadonilimab Injection in combination with Regorafenib for the treatment of intermediate to advanced hepatocellular carcinoma that has failed at least one prior systemic therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cadonilimab Injection in combination with Regorafenib | Experimental | Drug: Cadonilimab Injection, Drug: RegorafenibCadonilimab Injection in combination with Regorafenib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- written informed consent signed prior to enrolment.
- age > 18 years, both sexes
- patients with histologically or pathologically confirmed intermediate to advanced hepatocellular carcinoma.
- intermediate to advanced HCC previously treated with anti-PD-1/PD-L1 combined with anti-vascular targeting agents for HCC, with disease progression.
- Child-Pugh A or B.
Key exclusion criteria (0 listed)
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 InjectionAlso: AK104Cadonilimab Injection, 6mg/kg, intravenous drip ,q2w, | Drug | Cadonilimab Injection in combination with Regorafenib |
| RegorafenibRegorafenib 80mg, po, orally once daily | Drug | Cadonilimab Injection in combination with Regorafenib |
Primary outcome
Overall response rate ( ORR)
Time frame: up to 1 years
Defined as proportion of patients who have a best response of CR or PR
Overall survival (OS)
Time frame: up to 3 years
OS is defined as the time from date of neoadjuvant treatment start to the date of death from any cause or to the date of last follow-up if patients are alive. If a patient is alive by the time of final analysis, the patient will be censored at the last follow-up date.
Progress Free Survival （PFS）
Time frame: up to 3 years
Defined as the time from enrollment to disease progression or death (whichever occurs first)
Adverse Events (AEs)
Time frame: up to 3 years
Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0
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 Feb 2026.
- Individual participant dataSharing planned: No
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 1 study testing Cadonilimab Injection and Regorafenib in people with Advanced Hepatocellular Carcinoma That Has Failed at Least One Prior Systemic Therapy, run by Tianjin Medical University Cancer Institute and 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 30 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 9 Feb 2026. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
Overall response rate ( ORR) (time frame: up to 1 years). The study lists 4 primary outcomes in all. 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 Feb 2026.