Cadonilimab Plus TACE in Patients With Intermediate-stage Unresectable Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

Cadonilimab Combined With Transarterial Chemoembolization (TACE) in Patients With Intermediate-stage Unresectable Hepatocellular Carcinoma: A Single Center, Single Arm, Phase II Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05925413
• Other study ID #: EHBHKY2023-H006-P001
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: April 24, 2023
• Est. completion date: July 30, 2025

Study information

• Verified date: June 2023
• Source: Eastern Hepatobiliary Surgery Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 41
• Est. completion date: July 30, 2025
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Cadonilimab+TACE
Cadonilimab: 15mg/kg Q3W Day1 Select the best TACE treatment strategy. Traditional TACE (cTACE) or DEB-TACE can be selected. TACE treatment can be continued as needed based on disease control. The combination of cadonilimab is given 3 to 7 days after the first TACE treatment, and the subsequent administration of cardonilizumab is given once every 3 weeks, if the time overlaps with TACE treatment, it is generally administered 3 to 7 days after TACE treatment. Treatment was discontinued until intolerable toxicity, death, withdrawal of informed consent, initiation of a new antitumor therapy, or other reason specified in the protocol, whichever occurs first. Patients in this study received cadonilimab for up to 24 months.

Locations

Country	Name	City	State
China	Eastern hepatobilliary surgery hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Hepatobiliary Surgery Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR)	ORR is defined as the percentage of participants who have a confirmed complete response or partial response according to RECIST 1.1.	Up to 1 year
Secondary	Progression free survival (PFS)	PFS is defined as the time from enrollment of the trial to the first documented disease progression or death due to any cause.	Up to two years
Secondary	Overall survival (OS)	The duration from the date of recruitment to the date of death from any cause.	Up to two years
Secondary	Adverse events (safety)	Adverse events (safety ) will be evaluated according to the NCI CTCAE Version 5.0.The number and severity of treatment-related side effects, including AE and SAE, will be recorded during treatment.	Up to two years