NCT05025592

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

Conventional Transarterial Chemoembolization (cTACE) or Transarterial Chemoembolization (DEB-TACE) +HAIC Combined With Regorafenib ± Anti-PD1 Antibody for Unresected Hepatocellular Carcinoma

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Regorafenib	patients will received TACE-HAIC and regorafenib and anti-PD1 antibody or not
DEVICE	cTACE/DEB-TACE-HAIC	conventional transarterial chemoembolization(cTACE)/transarterial chemoembolization (DEB-TACE) plus hepatic artery infusion

Timeline

• Start date: 2021-09-10
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2021-08-27
• Last updated: 2021-09-02

Regulatory

• FDA-regulated drug study
• FDA-regulated device study