Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06375486
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-11
Brief Title:
Ivonescimab Combined With HAIC for the Treatment of Unresectable Hepatocellular CarcinomauHCC
Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Organization:
Tianjin Medical University Cancer Institute and Hospital
Study Overview
Official Title:
A Single-arm Single-center Phase II Clinical Study of AK112 a Dual-specific Antibody Against PD-1VEGF Combined With Hepatic Arterial Infusion Chemotherapy HAIC for the Treatment of Unresectable Hepatocellular Carcinoma
Status:
RECRUITING
Status Verified Date:
2024-04
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:
None
Brief Summary:
This study is a single-center open-label Phase II clinical trial aiming to enroll approximately 30 unresectable BCLC stage B or C hepatocellular carcinoma HCC patients from China The primary objective is to evaluate the safety and efficacy of AK112 a dual-specific antibody against PD-1VEGF in combination with hepatic arterial infusion chemotherapy HAIC for the treatment of unresectable hepatocellular carcinoma
All enrolled subjects will receive AK112 20mgkg Q3W combined with HAIC utilizing the FOLFOX chemotherapy regimen until the investigator determines no further clinical benefit based on RECIST v11 imaging evaluation and clinical assessment intolerable toxicity completion of 24 months of treatment or meeting other criteria for treatment discontinuation as outlined in the protocol whichever occurs first
All enrolled subjects will receive AK112 20mgkg Q3W combined with HAIC utilizing the FOLFOX chemotherapy regimen until the investigator determines no further clinical benefit based on RECIST v11 imaging evaluation and clinical assessment intolerable toxicity completion of 24 months of treatment or meeting other criteria for treatment discontinuation as outlined in the protocol whichever occurs first
Detailed Description:
This study is a single-center open-label Phase II clinical trial planning to enroll approximately 30 Chinese subjects with unresectable BCLC stage B or C hepatocellular carcinoma HCC The primary objective is to evaluate the safety and efficacy of AK112 a dual-specific antibody against PD-1VEGF in combination with hepatic arterial infusion chemotherapy HAIC for the treatment of unresectable hepatocellular carcinoma
All enrolled subjects will receive AK112 20mgkg Q3W in combination with HAIC utilizing the FOLFOX chemotherapy regimen until the investigator determines no further clinical benefit based on RECIST v11 imaging assessment and clinical evaluation intolerable toxicity completion of 24 months of treatment or meeting other criteria for treatment discontinuation as outlined in the protocol whichever comes first
The study consists of screening period up to 28 days from subject signing informed consent form to the first dose treatment period including treatment visits during treatment and end-of-treatment visit and follow-up period including safety follow-up visits disease progression follow-up visits and survival follow-up Subjects will undergo screening assessments within 28 days before the first dose to determine their eligibility for the study
All subjects will undergo regular tumor response assessments with objective response rate ORR evaluated by the investigator according to RECIST v11 and mRECIST criteria as the primary efficacy endpoint Within the first 48 weeks after the initial dose tumor assessments will be conducted every 6 weeks 7 days and after 48 weeks assessments will be performed every 12 weeks 7 days If a subject discontinues study treatment for reasons other than disease progression or death tumor assessments should continue according to a fixed schedule until radiographic progression or termination of study treatment whichever occurs first initiation of new anti-tumor therapy loss to follow-up death withdrawal of informed consent or study closure whichever occurs first Confirmation of objective response should occur at least 4 weeks after the initial documentation of response and in cases of clinical stability confirmation assessments can be performed at the next scheduled time point
Adverse events AEs will be followed up to 30 days after the last dose or initiation of new anti-tumor therapy whichever occurs first Serious adverse events SAEs will be followed up to 90 days after the last dose or initiation of new anti-tumor therapy whichever occurs first Survival assessments will be conducted every 3 months after the last dose and information on subsequent anti-tumor therapy will be collected after termination of study treatment
All enrolled subjects will receive AK112 20mgkg Q3W in combination with HAIC utilizing the FOLFOX chemotherapy regimen until the investigator determines no further clinical benefit based on RECIST v11 imaging assessment and clinical evaluation intolerable toxicity completion of 24 months of treatment or meeting other criteria for treatment discontinuation as outlined in the protocol whichever comes first
The study consists of screening period up to 28 days from subject signing informed consent form to the first dose treatment period including treatment visits during treatment and end-of-treatment visit and follow-up period including safety follow-up visits disease progression follow-up visits and survival follow-up Subjects will undergo screening assessments within 28 days before the first dose to determine their eligibility for the study
All subjects will undergo regular tumor response assessments with objective response rate ORR evaluated by the investigator according to RECIST v11 and mRECIST criteria as the primary efficacy endpoint Within the first 48 weeks after the initial dose tumor assessments will be conducted every 6 weeks 7 days and after 48 weeks assessments will be performed every 12 weeks 7 days If a subject discontinues study treatment for reasons other than disease progression or death tumor assessments should continue according to a fixed schedule until radiographic progression or termination of study treatment whichever occurs first initiation of new anti-tumor therapy loss to follow-up death withdrawal of informed consent or study closure whichever occurs first Confirmation of objective response should occur at least 4 weeks after the initial documentation of response and in cases of clinical stability confirmation assessments can be performed at the next scheduled time point
Adverse events AEs will be followed up to 30 days after the last dose or initiation of new anti-tumor therapy whichever occurs first Serious adverse events SAEs will be followed up to 90 days after the last dose or initiation of new anti-tumor therapy whichever occurs first Survival assessments will be conducted every 3 months after the last dose and information on subsequent anti-tumor therapy will be collected after termination of study treatment
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