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Hepatocellular CarcinomaPhase 2NCT06280105

A Trial of Cadonilimab Plus Regorafenib in Patients With Hepatocellular Carcinoma Who Failed Camrelizumab Combined With Apatinib

A Phase 2 study testing Cadonilimab+regorafenib in people with Hepatocellular Carcinoma, run by Meng Chao Hepatobiliary Hospital of Fujian Medical University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

To evaluate the efficacy and safety of cadonilimab combined with Regorafenib in patients with hepatocellular carcinoma who failed camrelizumab plus apatinib. 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?
Cadonilimab+regorafenib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
31 Mar 2024to 31 Mar 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

  • Sign a written informed consent form before enrollment;
  • Age >18 years old, both sex;
  • Histological or pathological confirmed intermediate or advanced hepatocellular carcinoma, or patients with cirrhosis who meet the clinical diagnostic criteria for hepatocellular carcinoma of the American Association for the Study of Liver Diseases (AASLD);
  • Have progressed on the combination treatment of camrelizumab and apatinib for HCC
  • Child-Pugh Class A;
  • ECOG PS score: 0~1;
Show all 31Show fewer
  • At least 1 measurable lesion (RECIST1.1)
  • Expected survival period≥12 weeks
  • The function of vital organs meets the following requirements (excluding the use of any blood components and cell growth factors within 14 days):
  • 1. Blood routine: Neutrophils≥1.5×109/L Platelet count ≥75×109/L Hemoglobin ≥ 90g/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); Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤ 10 times the upper limit of normal (ULN); urine protein < 2+; if urine protein ≥ 2+, 24-hour urine protein quantification shows that the protein must be ≤ 1g; 10. Normal coagulation function, no active bleeding or thrombosis disease
  • International normalized ratio INR≤1.5×ULN;
  • Partial thromboplastin time APTT≤1.5×ULN;
  • Prothrombin time PT≤1.5×ULN; 11. Non-surgical sterilization or female patients of childbearing age 12. Subjects voluntarily join this study, have good compliance, and cooperate with safety and survival follow-up
  • Main Exclusion Criteria:
  • Containing components such as fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, and cholangiocarcinoma that have been previously confirmed by histology/cytology;
  • Have a history of hepatic encephalopathy;
  • Have a history of liver transplantation;
  • There is clinically significant pericardial effusion, and there are clinical symptoms of pleural effusion that require drainage;
  • Clinically apparent ascites is defined as meeting the following criteria: ascites can be detected by physical examination during screening or ascites needs to be drained during screening;
  • Simultaneous infection with HBV and HCV (having a history of HCV infection but negative HCV RNA can be considered as not being infected with HCV);
  • Presence of central nervous system metastasis or meningeal metastasis
  • Bleeding from esophageal or gastric varices caused by portal hypertension has occurred within 6 months before the first dose
  • Patients with any bleeding or bleeding event ≥CTCAE grade 3 within 4 weeks before the first dose
  • Arterial and venous thromboembolic events occurred within 6 months before the first dose
  • Uncontrolled high blood pressure
  • Symptomatic congestive heart failure
  • Severe bleeding tendency or coagulation disorder
  • Have a history of gastrointestinal perforation and/or fistula, intestinal obstruction within 6 months before the first dose
  • Active autoimmune disease or a history of autoimmune disease
  • Patients with HIV
  • According to the investigator's judgment, patients with other serious concomitant diseases that endanger the patient's safety or affect the patient's completion of the study.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting

  • Mengchao Hepatobiliary Hospital, Fujian Medical University

    Fuzhou, Fujian

    Yong yi Zeng, 0591-88112829, lamp197311@126.com

    Recruiting

Other trials in China

About this study

Official title: A Single-arm, Multicenter, Phase II Trial of Cadonilimab Plus Regorafenib in Patients With Hepatocellular Carcinoma Who Progressed on Camrelizumab Combined With Apatinib

To evaluate the efficacy and safety of cadonilimab combined with Regorafenib in patients with hepatocellular carcinoma who failed camrelizumab plus apatinib.

Being tested
Cadonilimab+regorafenib
Keywords
cadonilimab (anti PD-1/CTLA-4 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.

  • Cadonilimab+regorafenibDrug

    cadonilimab: 6mg/kg iv D1 Q2W; regorafenib: 80mg QD oral; Eligible patients will receive cadonilimab combined with regorafenib, until disease progression or intolerable toxicity or death or withdrawal of informed consent, whichever occurred first

Study groups in NCT06280105
Study groupRoleWhat they receive
cadonilimab+regorafenibExperimentalNot described
Receives: Drug: Cadonilimab+regorafenib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. objective response rate (ORR) per RECIST1.1

    The proportion of all subjects with the best overall response (BOR) as complete remission (CR) or partial remission (PR) according to RECIST 1.1 criteria.

    Measured: Up to two years

Secondary outcomes (4)

  1. Progression-free survival（PFS）

    PFS was defined as the time from the first dose to the time of the first documented tumor progression (assessed by RECIST1.1 criteria) or the time of death from any cause, whichever occurred first.

    Measured: Up to two years

  2. Overall survival（OS）

    Defined as the time from the first dose to the death from any cause.

    Measured: Up to three years

  3. Duration of response (DOR)

    Defined as the time from the first dose to disease progression or death in patients who achieve complete or partial response

    Measured: Up to two years

  4. Occurence of AE and SAE

    Occurence of Adverse Event (AE) and Serious Adverse Event (SAE) （NCI CTCAE 5.0）

    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.

  1. First posted28 Feb 2024
  2. Study start31 Mar 2024
  3. Primary completion31 Mar 2026 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

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
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06280105
Sponsor's protocol ID
2023_148_01
Status last verified
May 2025
First submitted
19 Feb 2024
Last updated
15 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cadonilimab+regorafenib in people with Hepatocellular Carcinoma, run by Meng Chao Hepatobiliary Hospital of Fujian 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 31 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: looking for participants now, as of the sponsor's last update on 15 May 2025. 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?

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?

objective response rate (ORR) per RECIST1.1 (time frame: Up to two years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06280105.

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 15 May 2025.

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