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

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.

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

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Drug: Cadonilimab+TACE


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cadonilimab+TACE<br>Cadonilimab (15mg/kg Q3W D1)+TACE | Drug: Cadonilimab+TACE<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Overall survival (OS) | The duration from the date of recruitment to the date of death from any cause. | Up to two years | 
| 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 |