Actively Recruiting
HAIC Combined with Donafenib and Sintilimab As Perioperative Treatment for Resectable Hepatocellular Carcinoma Patients At High Risk of Recurrence: a Prospective, Multicenter, Randomized Phase II Study
Led by Fudan University · Updated on 2025-02-06
165
Participants Needed
3
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of treatments given around the time of surgery for patients with resectable hepatocellular carcinoma (HCC) who have a high risk of cancer returning. This phase II study compares three approaches: chemotherapy with hepatic arterial infusion combined with the drugs donafenib and sintilimab, donafenib and sintilimab without chemotherapy, and direct surgery without preoperative drug treatment. The goal is to find the best way to reduce recurrence and improve outcomes in these patients. Patients are randomly assigned to one of three groups. Group A receives two cycles of chemotherapy via hepatic arterial infusion every three weeks, along with donafenib and sintilimab, followed by surgery and then continuation of donafenib and sintilimab for six cycles. Group B receives donafenib and sintilimab without chemotherapy before surgery, then continues both drugs for six cycles after surgery. Group C undergoes direct surgery followed by six cycles of donafenib and sintilimab. Doses of donafenib may be adjusted based on the patient's condition, and sintilimab is given every three weeks intravenously. During the study, participants will be monitored regularly through scans and other assessments to measure outcomes such as one-year recurrence-free survival rate, tumor response, and overall survival up to three years. Researchers will also track safety and side effects throughout the trial. The total study participation may last up to several years to assess long-term benefits and risks. Participants will have scheduled visits to evaluate their health, treatment response, and any adverse events.
CONDITIONS
Brief 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 with expected R0 resection, sufficient liver remnant volume, and Child-Pugh class A
- At least one measurable lesion according to mRECIST criteria
- Tumor burden meeting one of the following: single tumor > 5 cm; multiple tumors with largest diameter > 3 cm and fewer than 5 tumors total; or portal vein tumor thrombus Vp1-Vp2
- Liver function with Child-Pugh score of 5-6
- ECOG performance status 0-1
- Life expectancy of at least 3 months
- Negative serum pregnancy test within 7 days prior to study drug for women of childbearing potential
- Use of reliable contraception during the study and for 60 days after last dose for men and women of childbearing potential
- For HBV-infected patients with HBV-DNA ≥ 10^4 copies/ml, antiviral therapy must reduce HBV-DNA to < 10^4 copies/ml before enrollment
- Adequate organ function
You will not qualify if you...
- Distant metastasis
- Portal vein tumor thrombosis Vp3-Vp4
- History of other malignant tumors within 5 years except certain skin and bladder cancers without recurrence
- History or presence of congenital or acquired immunodeficiency diseases
- Active or past autoimmune or inflammatory diseases excluding resolved vitiligo or childhood asthma
- History of severe psychiatric disorders
- Conditions affecting drug absorption or metabolism such as severe vomiting, chronic diarrhea, bowel obstruction
- Major surgery within 4 weeks before enrollment
- History of allogeneic stem cell or solid organ transplantation except corneal
- Recent systemic antitumor therapies or unresolved adverse events from prior treatments
- Use or anticipated need for systemic immunosuppressive drugs within 2 weeks before enrollment
- Concurrent use of drugs affecting QTc interval or drug metabolism
- Known allergy or hypersensitivity to study drugs or similar agents
- Uncontrolled hepatic encephalopathy, hepatorenal syndrome, ascites, or significant effusions
- Active bleeding, coagulation disorders, or recent gastrointestinal bleeding or perforation
- History of thrombosis or thromboembolic events within 6 months
- Significant cardiovascular disease including recent myocardial infarction, severe angina, heart failure, arrhythmias, or drug-resistant hypertension
- Active infection
- Other significant clinical or lab abnormalities that may affect safety
- Use of live attenuated vaccines within 4 weeks before or during the study
- Pregnant or breastfeeding women or those unwilling to use contraception
- History of substance abuse within 6 months
- Participation in other investigational drug or device trials within 4 weeks
- Inability to comply with study protocol or follow-up
- Any other conditions deemed by investigator to preclude participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 12 weeks before surgery plus 6 cycles of treatment after surgery
Participants receive perioperative treatment which may include HAIC combined with sintilimab and donafenib or sintilimab and donafenib alone before surgery, followed by surgery, and then continued treatment with sintilimab and donafenib for 6 cycles after surgery.
Multiple visits every 3 weeks during drug administration and surgery visit
Duration - Up to approximately 3 years
Participants are followed for recurrence-free survival and other outcomes up to 2 to 3 years after treatment completion.
Periodic visits for follow-up assessments
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.
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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