Actively Recruiting
Evaluation of Effectiveness and Safety of HAIC in Combination With Adebrelimab and Bevacizumab for Potentially Resectable Hepatocellular Carcinoma
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2024-07-15
40
Participants Needed
4
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Primary liver cancer mainly consists of three different pathologic types: hepatocellular carcinoma, intrahepatic cholangiocarcinoma, and hybrid HCC-ICC, of which HCC accounts for 90%. According to GLOBOCAN 2018 data, liver cancer is the sixth most prevalent tumor in the world, with about 841,100 new liver cancer cases and 781,600 deaths per year globally, which is the second leading cause of tumor deaths in men worldwide. China is a high incidence area of liver cancer, accounting for about 50% of the global incidence and deaths. The treatment of HCC varies according to disease stage, which is based on the BCLC classification system, Child-Pugh liver function rating, and extent of disease. Approximately 30% of HCC cases are diagnosed in the early stages (i.e., BCLC stage 0 or A), and the main treatment options include surgical resection, ablation techniques, and liver transplantation. However, the 5-year recurrence rate remains as high as 70%. The recommended treatment for intermediate stage HCC (i.e., BCLC stage B) is hepatic artery intervention, i.e., transarterial chemoembolization (TACE), but the scope of applicability is limited due to concomitant disease and liver impairment factors, some patients do not derive a survival benefit from it, and patients ultimately progress after treatment and are no longer suitable for further TACE. In recent years, the multi-drug combination therapy of systemic drugs combined with local therapy has also been gradually adopted, and studies have reported the feasibility of target drugs combined with ICI, TACE or HAIC for the treatment of unresectable hepatocellular carcinoma. The therapeutic aim of Adebrelimab (SHR-1316) is to inhibit tumor growth by specifically blocking the binding of PD-1 to PD-L1 and terminating the immunosuppressive signals generated by this receptor on T cells, so that T cells can re-recognize tumor cells and produce killing effects on them. This study proposes an evaluation to explore the efficacy and safety of irinotecan liposome-based hepatic arterial perfusion chemotherapy (FOLFIRI) in combination with adebrelimab and bevacizumab for the treatment of potentially resectable hepatocellular carcinoma.
CONDITIONS
Official Title
Evaluation of Effectiveness and Safety of HAIC in Combination With Adebrelimab and Bevacizumab for Potentially Resectable Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must voluntarily enroll and sign informed consent.
- Age between 18 and 75 years, male or female.
- Diagnosed with hepatocellular carcinoma by histology, cytology, or clinical diagnosis.
- Classified as CNLC-IIb to IIIa HCC (with specific portal vein thrombosis grades).
- No prior local or systemic treatment for HCC.
- At least one measurable lesion of specified size by CT scan per RECIST 1.1.
- Child-Pugh liver function score 7 or less.
- ECOG performance status of 0 or 1.
- Expected survival of at least 12 weeks.
- Adequate vital organ function as defined by blood counts, liver and kidney tests within 7 days before treatment.
- If active hepatitis B infection, must have low viral DNA levels and be on antiviral treatment for at least 14 days.
- Agree to use contraception for 120 days after consent and not breastfeeding.
You will not qualify if you...
- Diagnosis of hepatobiliary ductal cell carcinoma, sarcomatoid HCC, mixed cell carcinoma, or fibrous platysmal cell carcinoma.
- Other active malignant tumors within 5 years, except certain cured limited tumors.
- Portal vein thrombosis grade III or higher.
- Previous or planned organ or bone marrow transplantation.
- Moderate or severe ascites requiring treatment or pleural/pericardial effusion.
- Recent esophageal varices bleeding or severe varices.
- Arteriovenous thromboembolic events within 6 months.
- Known bleeding or clotting disorders, recent high-dose anticoagulant or antiplatelet use.
- Uncontrolled cardiac diseases or significant arrhythmias.
- Poorly controlled hypertension or recent vascular diseases.
- Severe wounds, recent major surgery, or gastrointestinal obstruction.
- Central nervous system metastases or major vascular tumor invasion.
- History of hepatic encephalopathy.
- Active or history of interstitial lung disease or pneumonia.
- Active autoimmune diseases or recent immunosuppressive therapy.
- Recent use of CYP3A4/CYP2C19 inducers or inhibitors.
- Severe infection within 4 weeks before treatment.
- Immune deficiency or combined hepatitis B and C infection.
- Prior anti-PD-1/PD-L1 immunotherapy.
- Recent radiotherapy or experimental drug use.
- Other conditions judged by investigators to affect study safety or results.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Not Yet Recruiting
2
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, China, 300308
Actively Recruiting
3
Third Central Hospital of Tianjin
Tianjin, Tianjin Municipality, China
Not Yet Recruiting
4
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, China
Not Yet Recruiting
Research Team
H
Huikai Li, MD
CONTACT
Y
Yang Liu, MD
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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