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Trial Title:
Cadonilimab Plus TACE in Patients With Intermediate-stage Unresectable Hepatocellular Carcinoma
NCT ID:
NCT05925413
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Cadonilimab+TACE
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.
Arm group label:
Cadonilimab+TACE
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Eastern hepatobilliary surgery hospital
Address:
City:
Shanghai
Zip:
200438
Country:
China
Start date:
April 24, 2023
Completion date:
July 30, 2025
Lead sponsor:
Agency:
Eastern Hepatobiliary Surgery Hospital
Agency class:
Other
Source:
Eastern Hepatobiliary Surgery Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05925413
