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

NCT06622031 | Recruiting

• 1 other identifier: Liver Projiect 11
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Carcinoma; Portal Vein Tumor Thrombus; Systemic Therapy

Keywords

Advanced hepatocellular carcinoma; Lenvatinib; Sintilimab; Camrelizumab; Tislelizumab; Transjugular intrahepatic portosystemic shunt; Main trunk portal vein tumor thrombus

Outcome Measures

Primary Outcomes (1)

• Rates of gastrointestinal hemorrhage

  atients occur gastrointestinal hemorrhage within 6 months after TIPS.

  6 months

Secondary Outcomes (4)

• Progression-Free-Survival (PFS)

  12 months

• Overall survival (OS)

  24 months

• Objective response rate (ORR)

  6 months

• Adverse events

  24 months

Study Arms (1)

Transjugular intrahepatic portosystemic shunt

EXPERIMENTAL

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.

Procedure: Transjugular intrahepatic portosystemic shunt; Drug: Lenvatinib; Drug: PD-1 inhibitor

Interventions

Transjugular intrahepatic portosystemic shunt PROCEDURE

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.

Also known as: TIPS

Transjugular intrahepatic portosystemic shunt

Lenvatinib DRUG

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

Transjugular intrahepatic portosystemic shunt

PD-1 inhibitor DRUG

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

Transjugular intrahepatic portosystemic shunt

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• metastases with limited five sites and no more two organs involved;
• Number of Intrahepatic tumors were no more than five;
• receipt of Lenvatinib and PD-1 inhibitor as the first-line systemic 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;
• 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.

You may not qualify if:

• recurrent HCC;
• PVTT at I-II grade by Cheng's criteria;
• age \< 18 years or \> 75 years;
• advanced HCC with more than five metastases;
• Number of Intrahepatic tumors were more than five;
• no response to Lenvatinib;
• life expectancy less than 3 months.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Chinese PLA General Hospital: collaborator

Study Sites (1)

Chinese PLA General hospital

Beijing, None Selected, 100853, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Portasystemic Shunt, Transjugular Intrahepatic; lenvatinib; Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Portasystemic Shunt, Surgical; Anastomosis, Surgical; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Officials

• Feng Duan

  Chinese PLA General Hospital

  STUDY DIRECTOR

Central Study Contacts

Qunfang Zhou, MD

CONTACT

86 19868000115; zhouqun988509@163.com

Feng Duan, MD

CONTACT

86 13910984586; duanfeng@vip.sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: TIPS procedure

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 1, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): August 30, 2027
• Last Updated: January 13, 2025

Record last verified: 2025-01

Locations

CN (1)