TACE Combined With Lenvatinib and PD-1 Inhibitor for Spontaneous Rupture of Hepatocellular Carcinoma: a Prospective Multicenter Study

Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Hepatocellular carcinoma (HCC) with spontaneous rupture is a potentially fatal complication and usually has poor prognosis. In most conditions, the tumors could not be radically moved. Then minimally therapy like transcatheter arterial chemoembolization (TACE) could effectively stanch the ruptured tumor and bleeding vessels. Then TACE combined the Lenvatinib and PD-1 inhibitor for this subtype HCC could effectively inhibit the tumor and improve the prognosis.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• diagnosis of primary HCC, confirmed histologically or clinically according to the criteria of the American Association for the Study of Liver Diseases;

• presence of hemostasis in the enhanced CT scan;

• integrity of the tumor is disrupted and there is hematoma around the liver;

• receipt of Lenvatinib and PD-1 inhibitor as the first-line systemic therapy;

• transarterial artery chemoembolization (TACE) as local therapy;

• classified as Child-Pugh class A or B and having an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2;

• no history of other malignancies.

• life expectancy more than 3 months;

• agreed to participated in this clinical trial;

⁃ Hemameba ≥3.0 x109/L, neutrophil ≥1.5x109/L, hemoglobin≥10.0 g/L, platelet≥100x 109/L, ALT; AST; bilirubin ≤1.5-fold normal, GFR≥60ml/min.

Locations
Other Locations
China
Qunfang Zhou
RECRUITING
Beijing
Contact Information
Primary
Qunfang Zhou, MD
zhouqun988509@163.com
86 19868000115
Backup
Mingyu Liu, MD
go1984liu@163.com
15626040233
Time Frame
Start Date: 2024-12-13
Estimated Completion Date: 2026-08-30
Participants
Target number of participants: 32
Treatments
Experimental: TACE plus Lenvatinib and PD-1 inhibitor
TACE was first performed, then Lenvatinib and PD-1 inhibitor were administered within seven days.
Related Therapeutic Areas
Sponsors
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov