Actively Recruiting
Sintilimab Combined SBRT As Neoadjuvant Therapy for Resectable HCC with PVTT
Led by West China Hospital · Updated on 2024-10-30
33
Participants Needed
1
Research Sites
102 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this single-arm, prospective clinical trial is to evaluate the safety and efficacy of neoadjuvant therapy combining sintilimab with stereotactic body radiation therapy (SBRT) in patients with resectable hepatocellular carcinoma (HCC) with branch portal vein tumor thrombus. The main questions it aims to answer are: 1. Is the combination of sintilimab and SBRT safe as neoadjuvant therapy? 2. How effective is this combination in treating resectable HCC with branch PVTT? Participants will be given a combination treatment of sintilimab and SBRT. Researchers will monitor their health conditions to assess the safety and effectiveness of this treatment protocol.
CONDITIONS
Official Title
Sintilimab Combined SBRT As Neoadjuvant Therapy for Resectable HCC with PVTT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years, any gender
- Voluntary informed consent with ability to follow study visits and procedures
- Diagnosis of hepatocellular carcinoma confirmed by histology, cytology, or characteristic imaging and lab tests
- Presence of measurable disease lesions per modified RECIST criteria
- Visible branch portal vein tumor thrombus (Vp1-Vp3 or Cheng I-II) deemed resectable after consultation
- No history of other cancers
- No prior treatments including targeted therapy, chemotherapy, interventional, surgery, or radiotherapy
- Expected survival of at least 3 months
- ECOG performance status of 0 or 1
- Liver function Child-Pugh A (score ≤6)
- Adequate organ and bone marrow function with specified lab values
- Female participants of childbearing potential must have a negative pregnancy test and use effective contraception during and 3 months after study
- Male participants with partners of childbearing potential must be surgically sterile or use effective contraception during and 3 months after study
You will not qualify if you...
- Prior interventional, immunotherapy, chemotherapy, or targeted therapy
- Confirmed distant metastasis or portal vein tumor thrombus involving the main portal vein (Vp4)
- Presence of refractory ascites or hepatic encephalopathy
- Concurrent cancer in other organs
- Impaired organ function preventing treatment tolerance
- Significant heart conditions such as arrhythmias, ischemia, severe blocks, heart failure, or valvular disease
- Severe bone marrow failure
- Active autoimmune disease requiring systemic treatment
- Participation in another oncology trial within 3 months
- History of active tuberculosis or uncontrolled infections
- Pregnant or breastfeeding
- History of HIV infection
- Any condition making study participation inappropriate as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
West China Hospital
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
Y
Yi Yang
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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