Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06187961
Status:
RECRUITING
Last Update Posted:
2024-01-03
First Post:
2023-12-08
Brief Title:
Combined HAIC Lenvatinib and Cadonilimab As Conversion Therapy for Unresectable Hepatocellular Carcinoma
Sponsor:
Tongji Hospital
Organization:
Tongji Hospital
Study Overview
Official Title:
A Phase 2 Open-label Single Arm Study of Combined HAIC Lenvatinib and Cadonilimab As Conversion Therapy for Unresectable Hepatocellular Carcinoma
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CCGLC-011
Brief Summary:
This is an open-label single-arm phase 2 study The purpose of study is to evaluate the feasibility and safety of hepatic arterial infusion chemotherapy combined with lenvatinib and cadonilimab as conversion therapy for unresectable hepatocellular carcinoma
Detailed Description:
Cadonilimab is the worlds first PD-1CTLA-4 bispecific antibody tumor immunotherapy new drug a tetrameric PD-1CTLA-4 bispecific antibody which can only bind to TIL tetravalent co-expressing PD-1 and CTLA-4 This design not only retains the efficacy observed in the combination therapy of PD-1 plus CTLA-4 inhibitors but also reduces the risk of activated T cells attacking healthy tissues thereby alleviating the toxicity problem outside the tumor On June 29 2022 the National Medical Products Administration of China approved the new drug Cadonilimab for the treatment of recurrent or metastatic cervical cancer patients who have failed platinum-based chemotherapy Currently a phase II clinical study of lenvatinib combined with Cadonilimab systemic treatment for advanced hepatocellular carcinoma is underway and preliminary results reveal that in 30 enrolled patients the ORR was 444 the DCR was 778 the treatment-related adverse reaction rate was 833 but the incidence of grade 3 or above adverse reactions was only 267 The safety of this antibody in patients is generally good This study intends to evaluate the safety and efficacy of HAIC combined with lenvatinib and cadonilimab as a conversion regimen in unresectable hepatocellular carcinoma
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None