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
NCT Number: NCT06482008
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Hepatocellular Carcinoma
Interventions: DRUG: Hepatic arterial infusion chemotherapy(HAIC) combined with adebrelimab plus apatinib
Sponsor: Sun Yat-sen University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 33
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-19
Completion Date: 2026-02-01

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 eligibility.HAIC 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 (0.25 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 v1.1 disease progression as identified by the investigator (after the subject has progressed in accordance with the definition of RECIST v1.1, 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 v1.1 criteria or termination of treatment, whichever occurs later. For subjects who end treatment for reasons other than investigator-confirmed disease progression (according to RECIST v1.1), 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 v1.1 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 v1.1, mRECIST, imRECIST) will need to be continued even if there is disease progression for one of the efficacy assessment criteria.

Primary Outcome Measures: ORR, Objective response rate, the percentage of subjects whose best remission (BOR) was determined by the investigator to be complete (CR) or partial remission (PR) according to RECIST v1.1, mRECIST, or imRECIST (under the imRECIST standard of CR, PR can recur after imaging disease progression), 12 months
Secondary Outcome Measures: TTP,Time to progression, Refers to the time from the date of first treatment to the occurrence of imaging disease progression, as determined by the investigator based on RECIST v1.1, mRECIST, or imRECIST (imaging disease progression under the imRECIST criteria needs to be confirmed by a subsequent ≥4-week evaluation or cannot be assessed any further, otherwise it is considered non-progression)., 12 months|PFS,Progression-free survival, : Time between first treatment and first imaging disease progression or death, whichever occurs first, as determined by the investigator based on RECIST v1.1, mRECIST, or imRECIST (imaging disease progression under the imRECIST criterion needs to be confirmed by a subsequent ≥4-week evaluation or cannot be assessed any further or is otherwise nonprogressive)., 12 months|DCR，Disease Control Rate, That is, the percentage of subjects in complete remission, partial remission, or stable disease (SD) for greater than or equal to 6 weeks as determined by the investigator based on RECIST v1.1, mRECIST, or imRECIST Example (CR, PR, and SD under the imRECIST criteria can reoccur following imaging disease progression), 12 months|DOR，Duration of Response, is the time between the first recording to objective remission (CR or PR) and the first occurrence of imaging disease progression or death, whichever occurs first, as determined by the investigator in accordance with RECIST v1.1, mRECIST, or imRECIST (under the imRECIST criteria it is the time between the first recording to objective remission (CR or PR) and the next occurrence of confirmed imaging disease progression or death (whichever occurs first))., 12 months|OS，Overall survival, Defined as the time between the date of first dose and the death of the subject due to all causes. Subjects who were alive at the last follow-up visit had OS counted as data censored at the time of the last follow-up visit. The OS of subjects who were lost to follow-up was counted as data censored at the time of last confirmed survival prior to the lost follow-up. OS for data censoring was defined as the time from first dose to censoring., 12 months|Incidence rate of AE, Based on the NCI-CTCAE v5.0 criteria, 12 months
Other Outcome Measures: TTD，Time to deterioration, is defined as the first deterioration in the following EORTC QLQ-C30 subscale scores (≥10-point decline relative to baseline) from the time of patient enrollment to the time of the first deterioration in the following EORTC QLQ-C30 subscale scores, which is sustained for at least 2 consecutive time points, or is sustained for 1 time point but is followed by death within the next 3 weeks (death from any cause), 12 months|EORTC QLQ-C30, The EORTC QLQ-C30 is the core scale in the system of quality-of-life measurement scales for cancer patients systematically developed by the European Organization for Research and Treatment of Cancer (EORTC) for the measurement of the quality of life of all cancer patients (measurement of their common components). The questionnaire consists of five functional scales (somatic, role, cognitive, emotional, and social), four symptom scales (fatigue, pain, nausea, and vomiting), a global health status scale, and several individual items (including dyspnea, loss of appetite, and insomnia). The questionnaire consisted of 30 multiple choice questions., 12 months|EORTC QLQ-HCC18, HCC module (EORTC QLQ-HCC18)., 12 months