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

Phase 2

Active, not recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Cadonilimab+TACE

• Registration Number: NCT05925413
• Lead Sponsor: Eastern Hepatobiliary Surgery Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-24
• Status Verified: 2023-06
• Study First Submitted: 2023-06-21
• Study First Submitted QC: 2023-06-21
• Last Update Submitted: 2023-06-21
• Study First Posted: 2023-06-29
• Last Update Posted: 2023-06-29
• Primary Completion: 2024-07-30
• Study Completion: 2025-07-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 41

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cadonilimab+TACE	Cadonilimab+TACE	Cadonilimab (15mg/kg Q3W D1)+TACE

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	Up to 1 year	ORR is defined as the percentage of participants who have a confirmed complete response or partial response according to RECIST 1.1.

Secondary Outcome Measures

Name	Time	Method
Progression free survival (PFS)	Up to two years	PFS is defined as the time from enrollment of the trial to the first documented disease progression or death due to any cause.
Adverse events (safety)	Up to two years	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.
Overall survival (OS)	Up to two years	The duration from the date of recruitment to the date of death from any cause.

Trial Locations

Locations (1)

Eastern hepatobilliary surgery hospital; 🇨🇳 Shanghai, Shanghai, China