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TIPS Combined With Lenvatinib and PD-1 Inhibitor for Advanced HCC With Main Trunk PVTT

ConditionsHepatocellular CarcinomaPortal Vein Tumor ThrombusSystemic Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University

About this trial

Hepatocellular carcinoma (HCC) with main trunk portal vein tumor thrombus (PVTT) has poor prognosis. The main lethiferous factor is the upper gastrointestinal hemorrhage by PVTT-related portal hypertension, then the second is the tumor-caused death. It is vital to prevent the portal hypertension by PVTT.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

presence of PVTT with III-IV grade by Cheng's criteria;

having PVTT induced portal hypertension;

with or without PVTT induced acute variceal bleeding;

Disqualifiers

recurrent HCC;

PVTT at I-II grade by Cheng's criteria;

age < 18 years or > 75 years;

advanced HCC with more than five metastases;

Trial design

Design model

Single group

Treatments tested in this trial

  • Transjugular intrahepatic portosystemic shunt

    Procedure/Surgery

    A needle punctured the portal vein through the transjugular approach. After a successful puncture, the parenchymal tract was dilated, and covered stents were introduced. The specifications of the covered stents were 8 mm × 50 mm, 8 mm × 60 mm, 8 mm × 70 mm, and 8 mm × 80 mm. All of the diameters of the bare stents were 8 mm, and the lengths were 50-80 mm. The portal vein pressure was measured before and after shunt creation. After the insertion of TIPS, all of the participants received a diuretic treatment and a salt-limited diet.

  • Lenvatinib

    Drug

    12 mg (body weight ≥60 kg) , 8 mg (body weight \<60 kg

  • PD-1 inhibitor

    Drug

    Tislelizumab (200mg intravenously every 3 weeks), Sintilimab (200mg intravenously every 3 weeks), Camrelizumab (200mg intravenously every 3 weeks)

Treatment groups

42 Participants
are divided into 1 treatment group
Group A: Transjugular intrahepatic portosystemic shuntExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Rates of gastrointestinal hemorrhage

atients occur gastrointestinal hemorrhage within 6 months after TIPS.

Time frame
6 months

Secondary outcomes

1

Progression-Free-Survival (PFS)

Progression was defined as progressive disease by independent radiologic review

Time frame
12 months
2

Overall survival (OS)

OS is the length of time from the date of inclusion until death from any cause.

Time frame
24 months
3

Objective response rate (ORR)

ORR, as determined based on tumor response according to RECIST 1.1, is defined as the proportion of all included patients whose best overall response (BOR) is either a complete response or partial response.

Time frame
6 months
4

Adverse events

Safety will be evaluated according to the NCI CTCAE Version 4.03. All observations

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Chinese PLA General Hospital

Collaborator

Source ClinicalTrials.gov
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