TerminatedNCT06851104Updated Feb 18, 2026

A Prospective Study of Cadonilimab in Hepatocellular Carcinoma After Radical Surgery With High Risk of Recurrence

A Phase 2 interventional study of Cadonilimab (AK104) in Hepatocellular Carcinoma (HCC), sponsored by Guangxi Medical University. Terminated at 1 site in China. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-18.

Sponsored by Guangxi Medical University · Phase 2, Interventional, and Prevention

Why this study was terminated

The support from the relevant company was not obtained as planned

Phase: Phase 2
Study type: Interventional
Enrollment: 45
Allocation: Not applicable
Ages: 18 Years to 70 Years
Sex: All

Study summary

This study aims to compare the safety and tolerability of cadonilimab applied after curative hepatectomy for hepatocellular carcinoma combined with high - risk recurrent factors.

Read the detailed description

Hepatectomy and local ablation are the main curative treatment methods for hepatocellular carcinoma, but the 5-year recurrence rate after surgery is as high as 70%, which is the main bottleneck problem affecting the long-term prognosis of patients. This study aims to investigate the safety and tolerability of cadonilimab (PD-1/cytotoxic T lymphocyte antigen-4 (CTLA-4) bispecific antibody) applied after curative hepatectomy for hepatocellular carcinoma combined with high - risk recurrence factors.

Conditions studied

Hepatocellular Carcinoma (HCC)

Browse trials for

Carcinoma, Hepatocellular 3,182

Keywords

hepatocellular carcinoma
hepatectomy
adjuvant
cadonilimab

In context

Carcinoma, Hepatocellular

3,182 studies on the registry are indexed under Carcinoma, Hepatocellular; 954 are open to participants now.

This study's enrollment of 45 is below the median of 55 across 2,298 interventional studies indexed under Carcinoma, Hepatocellular.

Browse Carcinoma, Hepatocellular studies →

Lead sponsor

Guangxi Medical University is the lead sponsor of 68 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Sign a written informed consent before the implementation of any trial-related procedures.
Male or female, aged ≥18 years and ≤70 years.
ECOG PS score is 0 - 1 point.
Subjects diagnosed with hepatocellular carcinoma by imaging criteria and/or pathology and who have received curative resection.
The definition of curative resection complies with the definition of curativeness in the 2024 edition of the Chinese Guidelines for Primary Liver Cancer (CNLC).
The postoperative recurrence risk stratification conforms to the high - risk group in the ERASL - pre or ERASL - post formula.
No prior systemic antitumor treatment for hepatocellular carcinoma has been received.
Child - Pugh liver function score of grade A or B7.
Expected survival time > 6 months.

Exclusion criteria

Exclusion Criteria:

Previously diagnosed by histology/cytology, including fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc.
Subjects with other malignant tumors within 5 years before enrollment, except for HCC. Subjects with other malignant tumors that have been cured by local treatment are not excluded, such as basal or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix or breast.
History of hepatic encephalopathy or liver transplantation.
Portal vein trunk or mesenteric superior vein, inferior vena cava tumor thrombus.

Study design

Phase: Phase 2
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 45 participants (actual)

Study arms

Experimental
Treatment arm
Patients with hepatocellular carcinoma after curative hepatectomy would receive cadonilimab 10 mg/kg intravenous infusion (dissolved in 0.9% NaCl 250 mL, within 60 minutes) Q3W, until disease progression, death, intolerance to toxicity, withdrawal of informed consent, initiation of new anti-tumor treatment, or termination of treatment for other reasons specified in the protocol. The maximum treatment duration for cadonilimab is 6 months.
Drug: Cadonilimab (AK104)

Interventions

DrugCadonilimab (AK104)
Patients with hepatocellular carcinoma after curative hepatectomy would receive cadonilimab 10 mg/kg intravenous infusion (dissolved in 0.9% NaCl 250 mL, within 60 minutes) Q3W, until disease progression, death, intolerance to toxicity, withdrawal of informed consent, initiation of new anti-tumor treatment, or termination of treatment for other reasons specified in the protocol. The maximum treatment duration for cadonilimab is 6 months.

What researchers measure

Primary outcomes

Recurrence-free survival
the recurrence-free survival would be calculated and compared among different groups.
Time frame: 2 years

Study locations

1 site

Guangxi Medical University Cancer Hospital
Nanning, Guangxi 530021, China

References and documents

Publications

Yuan G, Chen Y, Zhu P, Deng Q, Su K, Liu J, Wang Y, Li R, Li W, Zang M, Hu X, Wang JJ, Li Q, Du Y, Chen J. Cadonilimab (PD-1/CTLA-4) in combination with lenvatinib in unresectable hepatocellular carcinoma (uHCC): A retrospective real-world study. Heliyon. 2024 Sep 16;10(19):e37616. doi: 10.1016/j.heliyon.2024.e37616. eCollection 2024 Oct 15. PubMed 39398001 ↗
Wu X, Sun Y, Yang H, Wang J, Lou H, Li D, Wang K, Zhang H, Wu T, Li Y, Wang C, Li G, Wang Y, Li D, Tang Y, Pan M, Cai H, Wang W, Yang B, Qian H, Tian Q, Yao D, Cheng Y, Wei B, Li X, Wang T, Hao M, Wang X, Wang T, Ran J, Zhu H, Zhu L, Liu X, Li Y, Chen L, Li Q, Yan X, Wang F, Cai H, Zhang Y, Liang Z, Liu F, Huang Y, Xia B, Qu P, Zhu G, Chen Y, Song K, Sun M, Chen Z, Zhou Q, Hu L, Abulizi G, Guo H, Liao S, Ye Y, Yan P, Tang Q, Sun G, Liu T, Lu D, Hu M, Wang ZM, Li B, Xia M. Cadonilimab plus platinum-based chemotherapy with or without bevacizumab as first-line treatment for persistent, recurrent, or metastatic cervical cancer (COMPASSION-16): a randomised, double-blind, placebo-controlled phase 3 trial in China. Lancet. 2024 Oct 26;404(10463):1668-1676. doi: 10.1016/S0140-6736(24)02135-4. Epub 2024 Oct 16. PubMed 39426385 ↗

Individual participant data

Plan to share: Yes — Further enquiries can be directed to the corresponding author.

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06851104
Lead sponsor: Guangxi Medical University
Responsible party: Jian-Hong Zhong (Professor, Guangxi Medical University) — Principal investigator
First posted: Feb 28, 2025
Start date: Feb 16, 2025
Primary completion: Sep 15, 2025
Completion: Dec 31, 2025
Last update: Feb 18, 2026

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Carcinoma, Hepatocellular→

Other studies from this sponsor

Guangxi Medical University

Start the discussion