Actively Recruiting

Phase 2
Age: 18Years - 70Years
All Genders
NCT05407519

A Study to Evaluate Tislelizumab Combined With Sitravatinib as Adjuvant Therapy in Participants With HCC at High Risk of Recurrence After Curative Resection

Led by Anhui Provincial Hospital · Updated on 2023-03-22

40

Participants Needed

1

Research Sites

205 weeks

Total Duration

On this page

Sponsors

A

Anhui Provincial Hospital

Lead Sponsor

F

First Affiliated Hospital Xi'an Jiaotong University

Collaborating Sponsor

AI-Summary

What this Trial Is About

This is an open label, multi-center, single arm study to evaluate the efficacy and safety of tislelizumab combined with sitravatinib as adjuvant therapy in hepatocellular carcinoma (HCC) patients who are at high risk of recurrence after curative resection.

CONDITIONS

Official Title

A Study to Evaluate Tislelizumab Combined With Sitravatinib as Adjuvant Therapy in Participants With HCC at High Risk of Recurrence After Curative Resection

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of hepatocellular carcinoma confirmed by pathology or cytology
  • Underwent curative surgical resection
  • Considered high risk for HCC recurrence as defined by the study protocol
  • No prior systemic or local treatment for HCC
  • Child-Pugh Score Class A liver function
  • ECOG performance status of 0 or 1
  • Fully recovered from surgery
  • Adequate organ function
  • No major macrovascular invasion
  • No spread of cancer outside the liver
  • Life expectancy of at least 6 months
Not Eligible

You will not qualify if you...

  • Fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
  • Evidence of remaining, recurrent, or metastatic cancer
  • Serious allergy to tislelizumab or sitravatinib components
  • History of hepatic encephalopathy
  • Tumor thrombus in portal vein, superior mesenteric vein, or inferior vena cava
  • Portal hypertension with bleeding varices within 6 months before treatment
  • Bleeding or clotting disorder within 6 months before treatment
  • Any active cancer within 2 years before treatment
  • Active or history of autoimmune disease
  • Other serious acute or chronic conditions or psychiatric disorders increasing study risk
  • Pregnant or breastfeeding women

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Anhui province hospital

Hefei, Anhui, China, 230000

Actively Recruiting

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Research Team

L

Lianxin LIU secretary of the party committee

CONTACT

J

Jiabei WANG None

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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