NCT06646198

TIPS Plus Half-dose Donafenib in AHCC with PVTT-associated Portal Hypertension

Transjugular Intrahepatic Portosystemic Shunt (TIPS) Plus Half-dose Donafenib (a Kind of Anti-angiogenesis Agents) in Advanced HCC with Tumor Thrombosis-associated Portal Hypertension: a Prospective, Single-arm, Phase II Study. (DoTH Study)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Fei Gao · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of transjugular intrahepatic portosystemic shunt (TIPS) plus half-dose donafenib (a kind of anti-angiogenesis agents) in advanced hepatocellular carcinoma (BCLC-C Stage) accompanied by tumor thrombosis-associated portal hypertension.

Detailed description

This is a prospective, single-arm, phase II study to evaluate the efficacy and safety of transjugular intrahepatic portosystemic shunt (TIPS) plus half-dose donafenib (a kind of anti-angiogenesis agents) in advanced hepatocellular carcinoma (BCLC-C Stage) accompanied by tumor thrombosis-associated portal hypertension. Subjects who meet the admission criteria will be treated with half-dose donafenib after TIPS until disease progression, intolerable toxicity, death, withdrawal of the patient, or the researchers determined that the drug must be discontinued. The primary outcome measure is to evaluate the objective response rate (ORR) based on mRECIST. The secondary outcome measures include the duration of response (DOR), disease control rate (DCR), the recurrence rate of portal hypertension-related haemorrhage or ascites, the median progression-free survival time (mPFS) and median overall survival time (mOS). This study also aims to assess the safety and adverse events.

Conditions

• Hepatocellular Carcinoma with PVTT

Interventions

Type	Name	Description
PROCEDURE	Transjugular intrahepatic portosystemic shunt (TIPS)	Perform transjugular intrahepatic portosystemic shunt under the guidance of DSA
DRUG	Donafenib	Half-dose donafenib, 100mg BID P.O. unless any evidence of disease progression or unacceptable side effects.

Timeline

• Start date: 2024-10-08
• Primary completion: 2026-05-31
• Completion: 2026-12-31
• First posted: 2024-10-17
• Last updated: 2024-10-17

Locations

1 site across 1 country: China