Back to resultsCadonilimab Plus TACE in Patients With Intermediate-stage Unresectable Hepatocellular Carcinoma
Primary Purpose
Hepatocellular Carcinoma
Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Cadonilimab+TACE
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma
Eligibility Criteria
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 B7. 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 1. 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.
Sites / Locations
- Eastern hepatobilliary surgery hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cadonilimab+TACE
Arm Description
Cadonilimab (15mg/kg Q3W D1)+TACE
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Overall survival (OS)
The duration from the date of recruitment to the date of death from any cause.
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.
Full Information
NCT ID
NCT05925413
First Posted
June 21, 2023
Last Updated
June 21, 2023
Sponsor
Eastern Hepatobiliary Surgery Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05925413
Brief Title
Cadonilimab Plus TACE in Patients With Intermediate-stage Unresectable Hepatocellular Carcinoma
Official Title
Cadonilimab Combined With Transarterial Chemoembolization (TACE) in Patients With Intermediate-stage Unresectable Hepatocellular Carcinoma: A Single Center, Single Arm, Phase II Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 24, 2023 (Actual)
Primary Completion Date
July 30, 2024 (Anticipated)
Study Completion Date
July 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Hepatobiliary Surgery Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cadonilimab+TACE
Arm Type
Experimental
Arm Description
Cadonilimab (15mg/kg Q3W D1)+TACE
Intervention Type
Drug
Intervention Name(s)
Cadonilimab+TACE
Intervention Description
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.
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
ORR is defined as the percentage of participants who have a confirmed complete response or partial response according to RECIST 1.1.
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
Progression free survival (PFS)
Description
PFS is defined as the time from enrollment of the trial to the first documented disease progression or death due to any cause.
Time Frame
Up to two years
Title
Overall survival (OS)
Description
The duration from the date of recruitment to the date of death from any cause.
Time Frame
Up to two years
Title
Adverse events (safety)
Description
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.
Time Frame
Up to two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 B7.
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 1.
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.
Facility Information:
Facility Name
Eastern hepatobilliary surgery hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200438
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cadonilimab Plus TACE in Patients With Intermediate-stage Unresectable Hepatocellular Carcinoma
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