Actively Recruiting
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
Eligibility Criteria
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
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
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Anhui province hospital
Hefei, Anhui, China, 230000
Actively Recruiting
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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