Actively Recruiting
HAIC Combined with Donafenib and Sintilimab As Perioperative Treatment for Resectable Hepatocellular Carcinoma Patients At High Risk of Recurrence
Led by Fudan University · Updated on 2025-02-06
165
Participants Needed
3
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will evaluate the efficacy and safety of therapy perioperative treatment with HAIC combined with donafenib and sintilimab (group A)/ donafenib combined with sintilimab (group B) compared with direct surgery (group C) in resectable HCC patients who are at high risk for disease recurrence.
CONDITIONS
Official Title
HAIC Combined with Donafenib and Sintilimab As Perioperative Treatment for Resectable Hepatocellular Carcinoma Patients At High Risk of Recurrence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary enrollment with written informed consent obtained
- Age 18 to 75 years (inclusive), regardless of gender
- Histologically or pathologically confirmed previously untreated hepatocellular carcinoma (HCC) or clinically diagnosed previously untreated HCC according to the AASLD guidelines
- Initial resectable status as assessed by the investigator (expected to achieve R0 resection, sufficient liver remnant volume, and Child-Pugh class A, as per the "Chinese Expert Consensus on Neoadjuvant Therapy for Liver Cancer (2023 Edition)")
- At least one measurable lesion according to mRECIST criteria
- Tumor burden meets one of the following: a single tumor > 5 cm; multiple tumors with the largest > 3 cm and fewer than 5 tumors total; or presence of portal vein tumor thrombus (Vp1-Vp2)
- Liver function: Child-Pugh score of 5-6
- ECOG performance status 0-1
- Life expectancy of at least 3 months
- Women of childbearing potential must have a negative serum pregnancy test within 7 days before study drug administration
- Both women and men of childbearing potential must use reliable contraception during the study and for 60 days after the last dose
- For HBV-infected patients with HBV-DNA ≥ 10^4 copies/ml within 14 days before enrollment, antiviral therapy must be started to reduce HBV-DNA to < 10^4 copies/ml before entering the study, with continued monitoring
- Adequate organ function
You will not qualify if you...
- Patients with distant metastasis
- Patients with portal vein tumor thrombosis (Vp3-Vp4)
- History of any other malignant tumor within the past 5 years unless curatively treated with no recurrence, except certain skin and cervical carcinomas in situ
- History or current presence of congenital or acquired immunodeficiency diseases
- Active or prior autoimmune diseases or inflammatory disorders, except resolved vitiligo or childhood asthma not requiring adult intervention
- History of severe psychiatric disorders
- Conditions affecting absorption or metabolism of study drugs
- Major surgery within 4 weeks prior to enrollment
- History of allogeneic stem cell or solid organ transplantation (except corneal)
- Recent systemic antitumor therapies within 2 weeks or 5 half-lives prior to study drug administration
- Use or anticipated use of systemic immunosuppressive drugs within 2 weeks prior to enrollment
- Concurrent use of drugs that prolong QTc interval or affect drug metabolism
- Known allergies or hypersensitivity to study drugs or related agents
- Uncontrolled hepatic encephalopathy, hepatorenal syndrome, ascites, pleural or pericardial effusion
- Active bleeding or coagulation disorders or use of related treatments
- History of gastrointestinal bleeding or conditions predisposing to it within past 6 months
- History of gastrointestinal perforation, fistulas, or abscesses within past 6 months
- History of thrombosis or thromboembolic events within past 6 months
- Significant cardiovascular disease or uncontrolled hypertension
- Active infection
- Other significant clinical or laboratory abnormalities affecting safety
- Use of live attenuated vaccines within 4 weeks prior to enrollment or during study
- Pregnant or breastfeeding women or those unwilling/unable to use contraception
- History of substance abuse within past 6 months
- Participation in other clinical trials involving investigational drugs or devices within 4 weeks prior
- Inability to comply with study protocol
- Any other conditions that would preclude participation in the investigator's opinion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350014
Not Yet Recruiting
2
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200062
Actively Recruiting
3
TianJin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300000
Not Yet Recruiting
Research Team
L
Lu Wang, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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