Ignite Creation Date:
2024-07-17 @ 10:45 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06482008
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-14
Brief Title:
HAIC Combined With Adebrelimab Plus Apatinib as the First-line Treatment for HCC in BCLC Stage C An Open-label Single-arm Phase II Study
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
Hepatic Arterial Infusion Chemotherapy HAIC Combined With Adebrelimab Plus Apatinib as the First-line Treatment for Hepatocellular Carcinoma in Barcelona Clinic Liver Cancer Stage C An Open-label Single-arm Phase II Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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 is an open single-arm clinical study to observe and evaluate the efficacy and safety of first-line treatment of patients with stage C hepatocellular carcinoma of BCLC at HAIC in combination with adebrelimab and apatinib
Patients with stage C hepatocellular carcinoma of BCLC who have not received prior systemic therapy and cannot be resected will be selected for the study The study has objective response rate ORR as the primary study endpoint and is planned to enroll 33 subjects Patients eligible for enrollment will receive HAIC in combination with adebrelimab and apatinib
Subjects will receive study treatment after being fully informed and signing an informed consent form and being screened for eligibilityHAIC treatment FOLFOX regimen will be administered every 3 weeks until 6 treatments have been completed or HAIC treatment is terminated if the patient experiences intolerable adverse effects before 6 treatments have been achieved adebrelimab fixed dose 1200 mg IV D1 every 21 days Q3W in combination with Apatinib 250 mg 025 g orally once daily QD administered consecutively in 3-week 21-day treatment cycles Study treatment will continue until the subject develops an intolerable toxic reaction withdraws informed consent and progresses in accordance with RECIST v11 disease progression as identified by the investigator after the subject has progressed in accordance with the definition of RECIST v11 the subject may continue to receive study drug if the investigator assesses that the subject is still clinically beneficial and can tolerate the study treatment or if it is deemed that the subject no longer has clinical benefit then treatment may be terminated or other termination criteria specified in the protocol whichever occurs first
Subjects will all have a safety visit at D1 of each treatment cycle after enrollment in the study and will continue to have a safety visit and survival follow-up after completion of treatment
Tumor imaging assessment will be performed every 6 weeks after enrollment to assess efficacy Additional imaging examinations and assessments may be performed at any time during the study if clinically indicated Tumor imaging assessment will continue until there is disease progression confirmed by the investigator according to RECIST v11 criteria or termination of treatment whichever occurs later For subjects who end treatment for reasons other than investigator-confirmed disease progression according to RECIST v11 regular follow-up tumor imaging assessments will also continue after the end of treatment
If the subject withdraws consent has started other anti-tumour therapy other than PCPs or dies prior to the occurrence of investigator-confirmed disease progression according to RECIST v11 criteria or termination of treatment no further imaging assessment will be required If the subject does not meet the above termination criteria for imaging assessment the assessment of tumour efficacy for all three efficacy assessment criteria RECIST v11 mRECIST imRECIST will need to be continued even if there is disease progression for one of the efficacy assessment criteria
Patients with stage C hepatocellular carcinoma of BCLC who have not received prior systemic therapy and cannot be resected will be selected for the study The study has objective response rate ORR as the primary study endpoint and is planned to enroll 33 subjects Patients eligible for enrollment will receive HAIC in combination with adebrelimab and apatinib
Subjects will receive study treatment after being fully informed and signing an informed consent form and being screened for eligibilityHAIC treatment FOLFOX regimen will be administered every 3 weeks until 6 treatments have been completed or HAIC treatment is terminated if the patient experiences intolerable adverse effects before 6 treatments have been achieved adebrelimab fixed dose 1200 mg IV D1 every 21 days Q3W in combination with Apatinib 250 mg 025 g orally once daily QD administered consecutively in 3-week 21-day treatment cycles Study treatment will continue until the subject develops an intolerable toxic reaction withdraws informed consent and progresses in accordance with RECIST v11 disease progression as identified by the investigator after the subject has progressed in accordance with the definition of RECIST v11 the subject may continue to receive study drug if the investigator assesses that the subject is still clinically beneficial and can tolerate the study treatment or if it is deemed that the subject no longer has clinical benefit then treatment may be terminated or other termination criteria specified in the protocol whichever occurs first
Subjects will all have a safety visit at D1 of each treatment cycle after enrollment in the study and will continue to have a safety visit and survival follow-up after completion of treatment
Tumor imaging assessment will be performed every 6 weeks after enrollment to assess efficacy Additional imaging examinations and assessments may be performed at any time during the study if clinically indicated Tumor imaging assessment will continue until there is disease progression confirmed by the investigator according to RECIST v11 criteria or termination of treatment whichever occurs later For subjects who end treatment for reasons other than investigator-confirmed disease progression according to RECIST v11 regular follow-up tumor imaging assessments will also continue after the end of treatment
If the subject withdraws consent has started other anti-tumour therapy other than PCPs or dies prior to the occurrence of investigator-confirmed disease progression according to RECIST v11 criteria or termination of treatment no further imaging assessment will be required If the subject does not meet the above termination criteria for imaging assessment the assessment of tumour efficacy for all three efficacy assessment criteria RECIST v11 mRECIST imRECIST will need to be continued even if there is disease progression for one of the efficacy assessment criteria
Detailed Description:
None
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