Clinical trial · Interventional
Cadonilimab Plus TACE in Patients With Intermediate-stage Unresectable Hepatocellular Carcinoma
Cadonilimab Combined With Transarterial Chemoembolization (TACE) in Patients With Intermediate-stage Unresectable Hepatocellular Carcinoma: A Single Center, Single Arm, Phase II Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cadonilimab+TACE | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cadonilimab+TACE
- description
- Cadonilimab (15mg/kg Q3W D1)+TACE
- interventionNames
- Drug: Cadonilimab+TACE
Primary outcomes (1)
- measure
- Objective response rate (ORR)
- timeFrame
- Up to 1 year
- description
- ORR is defined as the percentage of participants who have a confirmed complete response or partial response according to RECIST 1.1.
Secondary outcomes (3)
- measure
- Progression free survival (PFS)
- timeFrame
- Up to two years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. written informed consent signed prior to enrolment. 2. age \> 18 years, both sexes 3. patients with histologically or pathologically confirmed intermediate hepatocellular carcinoma; BCLC stage B or CNLC stage II 4. no previous antitumor therapy 5. Child-Pugh A or B7. 6. 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). 7. ECOG PS score: 0 to 1. 8. expected survival of \>12 weeks. 9. Adequate organ function Exclusion Criteria: 1. BCLC C stage HCC 2. 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). 3. With uncontrolled hepatitis B (HBV-DNA\>2000 IU/ml and elevated ALT). 4. Multi-nodules hepatocellular carcinoma beyond hemi-hepatic range. 5. Patients with tumor thrombus reaches or exceeds the portal vein. 6. History of other malignancies. 7. History of allergic reactions to related drugs. 8. History of organ transplantation. 9. Pregnant women, nursing mothers. 10. Patients have other factors that may interfere with patient enrollment and assessment results. 11. Refuse follow-up as required by this study protocol and refuse to sign informed consent.
References
Publications (0)
Data not yet available