Actively Recruiting
TIPS Plus Half-dose Donafenib in AHCC with PVTT-associated Portal Hypertension
Led by Fei Gao · Updated on 2024-10-17
40
Participants Needed
1
Research Sites
116 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 half-dose donafenib (a kind of anti-angiogenesis agents) in advanced hepatocellular carcinoma (BCLC-C Stage) accompanied by tumor thrombosis-associated portal hypertension.
CONDITIONS
Official Title
TIPS Plus Half-dose Donafenib in AHCC with PVTT-associated Portal Hypertension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient voluntarily agrees and signs informed consent
- Age between 18 and 75 years, any gender
- Pathologically confirmed hepatocellular carcinoma with at least one measurable tumor focus without prior local treatment
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
- BCLC-C stage hepatocellular carcinoma with tumor thrombosis-associated portal hypertension
- Newly diagnosed patients with no prior local or systemic therapy
- Expected survival of 3 months or more
- Adequate vital organ function as specified, including neutrophils 1.5�7/L, platelets 50�7/L, hemoglobin 60 g/L, serum albumin 28 g/L, TSH 1�7ULN with normal FT3 and FT4 if abnormal, bilirubin 2�7ULN, ALT and AST 5�7ULN, serum creatinine 1.5�7ULN
- Child-Pugh score =13 points
- Presence of portal hypertension-related complications such as gastrointestinal bleeding, refractory or recurrent ascites, hepatic pleural effusion, or portal vein tumor thrombus exceeding 50% of lumen area
- Use of medically approved contraception for non-surgically sterilized or childbearing female patients and male patients with partners of childbearing potential during treatment and for 3 months after
You will not qualify if you...
- Active or history of autoimmune disease
- Use of immunosuppressive agents or systemic hormone therapy exceeding 10 mg/day prednisone equivalent within 2 weeks before enrollment
- Severe allergic reactions to donafenib or iodine-containing contrast media
- Central nervous system metastasis
- Previous liver transplantation
- Tumor thrombus extending beyond the portal vein to other veins or heart chambers
- Uncontrolled high blood pressure (systolic 140 mmHg or diastolic 90 mmHg)
- Uncontrolled cardiac symptoms or diseases including heart failure (NYHA 2), unstable angina, recent myocardial infarction, significant arrhythmia, prolonged QTc interval
- Abnormal coagulation or bleeding tendencies requiring anticoagulation therapy except preventive low-dose aspirin or heparin
- Child-Pugh score above 13 points
- Recent arterial or venous thrombosis events within 6 months
- Known bleeding or clotting disorders
- Significant proteinuria exceeding specified levels
- Active infection or fever above 38.5 C or high white blood cell count within 7 days before treatment
- Congenital or acquired immune deficiencies such as HIV
- Moderate to severe pulmonary hypertension
- Other malignancies within the past 3 years except certain cured skin or cervical cancers
- Previous anti-PD-1/PD-L1 or apatinib therapy
- Other conditions or factors that may affect study results or patient safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University
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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