Early Transjugular Intrahepatic Portosystemic Shunt for Advanced Hepatocellular Carcinoma

NCT06624098 | Recruiting

• 1 other identifier: Liver Projiect 12
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

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. Studies have proven that early transjugular intrahepatic portosystemic shunt (TIPS) with 72 hours after acute variceal bleeding is effective.

Conditions

Advanced Hepatocellular Carcinoma; Variceal Bleeding

Keywords

Advanced hepatocellular carcinoma; Variceal bleeding; Therapeutic endoscopy; Transjugular intrahepatic portosystemic shunt

Outcome Measures

Primary Outcomes (1)

• Rates of technical success

  Patients did not occur gastrointestinal hemorrhage and the stent unobstructed 3 months after TIPS.

  3 months

Secondary Outcomes (5)

• Rates of gastrointestinal hemorrhage

  6 months

• Progression-Free-Survival (PFS)

  12 months

• Overall survival (OS)

  12 months

• Objective response rate (ORR)

  12 months

• Adverse events

  12 months

Study Arms (1)

Early transjugular intrahepatic portosystemic shunt (TIPS)

EXPERIMENTAL

TIPS was performed within 72 hours after the endoscopic hemostasis.

Procedure: Early TIPS

Interventions

Early TIPS PROCEDURE

TIPS was performed within 72 hours after the endoscopic hemostasis.

Early transjugular intrahepatic portosystemic shunt (TIPS)

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;
• TIPS was performed within 72 hours after the endoscopic hemostasis;
• 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 (2)

Chinese PLA General hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Chinese PLA General hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Study Officials

• Feng Duan, MD

  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
• Masking Details: TIPS was performed within 72 hours after variceal bleeding.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Early transjugular intrahepatic portosystemic shunt (TIPS) within 72 hours after acute variceal bleeding.

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 2, 2024
• Study Start: October 1, 2024
• Primary Completion: December 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: October 2, 2024

Record last verified: 2024-10

Locations

CN (2)