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

NCT ID: NCT05025592

Last Updated: 2021-09-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-10
• Study Completion Date: 2022-12-31

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.

Conditions

HCC; Transarterial Chemoembolization; Hepatic Arterial Infusion Chemotherapy; Regorafenib

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

cTACE/DEB-TACE-HAIC+regorafenib±anti-PD1 antibody

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.

Regorafenib

Intervention Type: DRUG

patients will received TACE-HAIC and regorafenib and anti-PD1 antibody or not

cTACE/DEB-TACE-HAIC

Intervention Type: DEVICE

conventional transarterial chemoembolization(cTACE)/transarterial chemoembolization (DEB-TACE) plus hepatic artery infusion

Interventions

Regorafenib

patients will received TACE-HAIC and regorafenib and anti-PD1 antibody or not

Intervention Type: DRUG

cTACE/DEB-TACE-HAIC

conventional transarterial chemoembolization(cTACE)/transarterial chemoembolization (DEB-TACE) plus hepatic artery infusion

Intervention Type: DEVICE

Other Intervention Names

anti-PD1 antibody; conventional transarterial chemoembolization(cTACE)/transarterial chemoembolization (DEB-TACE) plus hepatic artery infusion

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: lead

Responsible Party

Zhu Xu

Hospital Chief Physician，MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2021KT83

Identifier Type: -

Identifier Source: org_study_id