cTACE or DEB-TACE+HAIC Combined With Regorafenib ± Anti-PD1 Antibody for uHCC

• Conditions: Transarterial Chemoembolization; Regorafenib; HCC; Hepatic Arterial Infusion Chemotherapy
• Interventions: Drug: Regorafenib; Device: cTACE/DEB-TACE-HAIC

• Registration Number: NCT05025592
• Lead Sponsor: Peking University Cancer Hospital & Institute

Brief Summary

explore the effectiveness and safety of conventional transarterial chemoembolization (cTACE) or transarterial chemoembolization (DEB-TACE) plus hepatic arterial Infusion chemotherapy (HAIC) combined with regorafenib and anti-PD-1 antibody or not for unresected hepatocellular carcinoma (uHCC)

Detailed Description

This is a non-randomized, open, single-arm clinical study. Patients receive cTACE/DEB-TACE+HAIC treatment( 6-8 weeks as a cycle) and regorafenib and anti-PD1 antibody or not until the disease progresses, intolerable toxicity occurs, the patient is lost to follow-up or death, or situations other judged by researchers which treatment should be stopped.

Study Timeline

• Status Verified: 2021-08
• Study First Submitted: 2021-08-24
• Study First Submitted QC: 2021-08-24
• Study First Posted: 2021-08-27
• Last Update Submitted: 2021-08-28
• Last Update Posted: 2021-09-02
• Study Start: 2021-09-10
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Volunteer to participate and sign the informed consent in writing;
2. Age: 18-75 years old;
3. No gender limit;
4. Unresectable hepatocellular carcinoma with clear pathological diagnosis or clinical diagnosis;
5. Unresectable hepatocellular carcinoma patients who failed first-line treatment (including but not limited to sorafenib, lenvatinib, atezolizumab combined with bevacizumab, etc.);
6. At least one measurable lesion (according to mRECIST criteria) imaging diagnosis time ≤ 21 days from selection;
7. Child-pugh grade A-B7 grade
8. The expected survival period is ≥3 months;
9. General physical condition (ECOG) 0-2;
10. Sufficient bone marrow hematopoietic function (within 7 days): hemoglobin ≥9 g/dL, white blood cells ≥3.0×10^9/L, neutrophils ≥1.5x 10^9/L, platelets ≥80x 10^9/L; liver and kidney functions are normal; (Within 14 days): TBIL≤1.5 times the upper limit of normal; ALT and AST≤5 times the upper limit of normal; creatinine≤1.5 times the upper limit of normal; INR≤1.7 or prolonged PT≤4s.

Exclusion Criteria

1. Those who are currently receiving other effective treatments;
2. Patients who have received regorafenib in the past;
3. Patients who have participated in other clinical trials within 4 weeks before enrollment;
4. Unable to cooperate with cTACE and HAIC treatment;
5. Patients with primary malignant tumors other than hepatocellular carcinoma at the same time, except for cured skin basal cell carcinoma and cervical carcinoma in situ;
6. Clinically significant cardiovascular diseases, such as heart failure (NYHA III-IV), uncontrolled coronary heart disease, cardiomyopathy, arrhythmia, uncontrolled hypertension or a history of myocardial infarction within the past 1 year;
7. Neurological or mental abnormalities that affect cognitive ability, including central nervous system transfer;
8. There were active serious clinical infections (>grade 2 NCI-CTCAE version 4.0), including active tuberculosis within 14 days before enrollment;
9. Known or self-reported HIV infection;
10. Uncontrolled systemic diseases, such as poorly controlled diabetes;
11. Known to have hypersensitivity or allergic reactions to any component of the study drug;
12. Pregnancy (determined by serum β-chorionic gonadotropin test) or breast-feeding

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
cTACE/DEB-TACE-HAIC+regorafenib±anti-PD1 antibody	cTACE/DEB-TACE-HAIC	patients will receive the combination treatment of cTACE/DEB-TACE plus HAIC and combined with regorafenib and anti-PD1 antibody or not. The anti-PD-1 antibody will be used depended on the contraindications or wishes of patients.
cTACE/DEB-TACE-HAIC+regorafenib±anti-PD1 antibody	Regorafenib	patients will receive the combination treatment of cTACE/DEB-TACE plus HAIC and combined with regorafenib and anti-PD1 antibody or not. The anti-PD-1 antibody will be used depended on the contraindications or wishes of patients.

Primary Outcome Measures

Name	Time	Method
Progression free overall survival，PFS	12 months	PFS was defined as the interval between the time at which treatment was initiated and intrahepatic tumor and/or extrahepatic tumor progression, symptomatic progression, including massive ascites and liver function that was categorized as Child-Pugh grade C, or death from any cause
Objective response rate, ORR	6 months	The objective response rate (ORR) was defined as the complete response (CR) rate + the partial response (PR) rate
Overall survival，OS	24 months	overall survival (OS) was defined as the interval between the time at which treatment was initiated and death or the last follow-up assessment

Secondary Outcome Measures

Name	Time	Method
Disease control rate, DCR	6 months	disease control rate (DCR) was defined as the CR rate + the PR rate + the stable disease (SD) rate