NCT05925413Active, not recruitingPhase 2
Cadonilimab Combined With Transarterial Chemoembolization (TACE) in Patients With Intermediate-stage Unresectable Hepatocellular Carcinoma: A Single Center, Single Arm, Phase II Trial
Eastern Hepatobiliary Surgery Hospital1 site in 1 country41 target enrollmentStarted: April 24, 2023Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- Objective response rate (ORR)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •written informed consent signed prior to enrolment.
- •age > 18 years, both sexes
- •patients with histologically or pathologically confirmed intermediate hepatocellular carcinoma; BCLC stage B or CNLC stage II
- •no previous antitumor therapy
- •Child-Pugh A or B
- •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).
- •ECOG PS score: 0 to
- •expected survival of >12 weeks.
- •Adequate organ function
Exclusion Criteria
- •BCLC C stage HCC
- •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).
- •With uncontrolled hepatitis B (HBV-DNA>2000 IU/ml and elevated ALT).
- •Multi-nodules hepatocellular carcinoma beyond hemi-hepatic range.
- •Patients with tumor thrombus reaches or exceeds the portal vein.
- •History of other malignancies.
- •History of allergic reactions to related drugs.
- •History of organ transplantation.
- •Pregnant women, nursing mothers.
- •Patients have other factors that may interfere with patient enrollment and assessment results.
- •Refuse follow-up as required by this study protocol and refuse to sign informed consent.
Arms & Interventions
Cadonilimab+TACE
Experimental
Cadonilimab (15mg/kg Q3W D1)+TACE
Intervention: Cadonilimab+TACE (Drug)
Outcomes
Primary Outcomes
Objective response rate (ORR)
Time Frame: 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 Outcomes
- Adverse events (safety)(Up to two years)
- Progression free survival (PFS)(Up to two years)
- Overall survival (OS)(Up to two years)
Investigators
Shen Feng
Professor and Chief Surgeon
Eastern Hepatobiliary Surgery Hospital
Study Sites (1)
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