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

NCT05925413 | Unknown Phase 2

• 1 other identifier: EHBHKY2023-H006-P001
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Progression free survival (PFS)

  Up to two years

• Overall survival (OS)

  Up to two years

• Adverse events (safety)

  Up to two years

Study Arms (1)

Cadonilimab+TACE

EXPERIMENTAL

Cadonilimab (15mg/kg Q3W D1)+TACE

Drug: Cadonilimab+TACE

Interventions

Cadonilimab+TACE DRUG

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.

Cadonilimab+TACE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eastern Hepatobiliary Surgery Hospital: lead

Study Sites (1)

Eastern hepatobilliary surgery hospital

Shanghai, Shanghai Municipality, 200438, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief Surgeon

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: June 29, 2023
• Study Start: April 24, 2023
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2025
• Last Updated: June 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)