Actively Recruiting
TIPS Plus Cadonilimab in Advanced HCC with Tumor Thrombosis-associated Portal Hypertension:a Prospective, Single-arm, Phase II Study
Led by Fei Gao · Updated on 2024-10-16
30
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the efficacy and safety of transjugular intrahepatic portosystemic shunt (TIPS) plus Cadonilimab (a PD-1/CTLA-4 bispecific antibody) in advanced hepatocellular carcinoma (BCLC-C Stage) accompanied by tumor thrombosis-associated portal hypertension.
CONDITIONS
Official Title
TIPS Plus Cadonilimab in Advanced HCC with Tumor Thrombosis-associated Portal Hypertension:a Prospective, Single-arm, Phase II Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient voluntarily agrees to participate and signs informed consent
- Aged between 18 and 75 years, male or female
- Clinically or pathologically confirmed hepatocellular carcinoma with at least one measurable tumor lesion
- Child-Pugh liver function score of 13 points or less
- BCLC-C stage with tumor thrombosis-associated portal hypertension
- Newly diagnosed without prior targeted therapy or immunotherapy
- ECOG performance status score of 0 or 1
- Expected survival of at least 12 weeks
- Adequate vital organ function based on blood counts and lab tests
- Use of medically approved contraception during treatment and for 3 months after, if applicable
- Negative pregnancy test and non-lactating if female of childbearing potential
You will not qualify if you...
- Active autoimmune disease or history of autoimmune disease
- Use of immunosuppressive agents or systemic steroids above 10 mg/day prednisone equivalent within 2 weeks before enrollment
- Two or more prior systemic treatment lines
- Severe allergic reactions to monoclonal antibodies
- Known central nervous system metastasis or hepatic encephalopathy
- Prior liver transplantation
- Tumor thrombus outside the portal vein (e.g., hepatic vein, inferior vena cava)
- Poorly controlled high blood pressure (systolic 140 mmHg or diastolic 90 mmHg)
- Uncontrolled cardiac symptoms or diseases including heart failure NYHA level 2 or higher
- Abnormal coagulation or bleeding disorders
- Child-Pugh score above 13 points
- Recent arterial or venous thrombosis events within 6 months
- Known bleeding or thrombotic disorders
- Recent radiotherapy, chemotherapy, hormone therapy, or surgery less than 4 weeks prior
- Active infection or fever above 38.5C within 7 days prior
- Moderate to severe pulmonary hypertension
- Other malignancies within past 3 years except certain skin or cervical cancers
- Prior anti-PD-1/PD-L1 or apatinib therapy
- Recent live vaccine within 4 weeks prior
- Other serious diseases or conditions affecting study participation or safety
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
F
Fei Gao, M.D.，Ph.D.
CONTACT
H
Han Qi, M.D.
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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