HAIC Combined With Adebrelimab Plus Apatinib as the First-line Treatment for HCC in BCLC Stage C:… (NCT06482008) | Clinical Trial Compass
Not Yet RecruitingPhase 2
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
33 participantsStarted 2024-06-19
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients voluntarily enrolled in the study and signed an informed consent form;
. ≥18 years of age (counted on the date of signing informed consent), both male and female;
. Patients with hepatocellular carcinoma diagnosed by EASL/AASLD diagnostic criteria, pathohistological or cytological confirmation;
. Subjects must be able to provide fresh or archived tumour tissue (formalin-fixed, paraffin-embedded \[FFPE\] tissue blocks or at least 5 unstained FFPE slides) and their pathology report. If the subject can provide less than 5 unstained slides or if tumour tissue is not available (e.g., exhausted because of previous diagnostic testing), enrolment may be allowed on a case-by-case basis after discussion;
. Barcelona Clinical Liver Cancer Staging (BCLC, see Annex 1) stage C and not suitable for surgery or progressed after surgery and/or local treatment;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Patients who have progressed after local therapy, where local therapy (including but not limited to surgery, radiotherapy, hepatic artery embolisation, TACE, hepatic artery perfusion, radiofrequency ablation, cryoablation, or percutaneous ethanol injection) has been completed at least 4 weeks prior to the baseline imaging scan and where toxic reactions (other than alopecia) due to local therapy must have recovered to the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 ( NCI-CTCAE v5.0) rating ≤ Grade 1;
. not have received any prior systemic therapy for HCC
. At least one measurable lesion (spiral CT scan length ≥ 10 mm or short diameter of enlarged lymph node ≥ 15 mm according to RECIST v1.1; lesions previously treated with localised therapy can be used as target lesions after definitive progression according to RECIST v1.1).
Exclusion criteria
. Known hepatobiliary cell carcinoma, sarcomatoid HCC, mixed cell carcinoma and fibroblastic laminar cell carcinoma; and other active malignant tumours other than HCC within 5 years or concurrently. Cured limited tumours such as basal cell carcinoma of the skin, squamous carcinoma of the skin, superficial bladder carcinoma, carcinoma in situ of the prostate, carcinoma in situ of the cervix, and carcinoma in situ of the breast may be enrolled;
. Patients who are preparing for or have previously undergone organ or allogeneic bone marrow transplantation;
. Have received other experimental drug therapy within 28 days prior to initiation of study treatment;
. Those with clinically symptomatic moderate or severe ascites i.e. requiring therapeutic puncture or drainage or Child-Pugh score \>2 (except for those with only a small amount of ascites on imaging but without clinical symptoms); uncontrolled or moderate or greater pleural effusion, pericardial effusion;
. History of gastrointestinal bleeding or a definite propensity for gastrointestinal bleeding within 6 months prior to the start of study treatment;
. Abdominal fistula, gastrointestinal perforation or abdominal abscess within 6 months prior to start of study treatment;
. Known hereditary or acquired bleeding (e.g., coagulation disorders) or thrombotic tendencies, such as in patients with haemophilia; current or recent (within 10 days prior to start of study treatment) use of full-dose oral or injectable anticoagulant or thrombolytic medications for therapeutic purposes (prophylactic use of low-dose aspirin, low molecule heparin is permitted);
. Have had a thrombotic or embolic event, such as cerebrovascular accident (including transient ischaemic attack, cerebral haemorrhage, cerebral infarction), pulmonary embolism, etc., within 6 months prior to the start of study treatment;