Actively Recruiting
Single Arm, Prospective, Multicenter Clinical Study of TACE With Adebrelimab and Bevacizumab for Unresectable Hepatocellular Carcinoma
Led by The First Affiliated Hospital of Xiamen University · Updated on 2024-02-28
71
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital of Xiamen University
Lead Sponsor
J
Jiangsu HengRui Medicine Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
To evaluate the efficacy and safety of TACE combined with adebrelimab and bevacizumab transformation in unresectable hepatocellular carcinoma
CONDITIONS
Official Title
Single Arm, Prospective, Multicenter Clinical Study of TACE With Adebrelimab and Bevacizumab for Unresectable Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, male or female
- Diagnosed with primary hepatocellular carcinoma meeting clinical or pathological criteria, with at least one measurable lesion per RECIST 1.1
- No prior systemic treatment and inoperable for surgery or radical ablation but can tolerate TACE
- CNLC stage Ia to IIb
- Child-Pugh liver function grade A or B (5-7 points)
- ECOG performance status score of 0 or 1
- Expected survival time of at least 12 weeks
- If active hepatitis B infection, HBV DNA less than 2000 IU/mL and on antiviral treatment at least 14 days before study start; hepatitis C patients must be on antivirals with liver function grade CTCAE 1 or less
- Normal function of main organs meeting specific blood count and biochemical standards
- Women of childbearing age must have negative pregnancy test within 7 days before enrollment and agree to use contraception during treatment and 24 weeks after last dose; men must agree to use contraception during and 24 weeks after last dose
- Willingness to participate voluntarily and comply with study follow-up
You will not qualify if you...
- Pregnant or breastfeeding women
- Pathology showing cholangiocarcinoma or mixed cell carcinoma
- Diffuse liver cancer
- Autoimmune diseases, organ or stem cell transplant, or other malignancies except cured basal skin cell carcinoma or cervical carcinoma in situ
- Mental illness or inability to cooperate with treatment
- Participation in other clinical trials within the last 3 months
- History of other cancers or prior PD-1/PD-L1 inhibitor therapy
- Major surgery, chemotherapy, or systemic therapy for target lesions within 1 month before enrollment
- Use of immunosuppressants or systemic steroids >10mg prednisone within 14 days before enrollment
- Liver function Child-Pugh C not improved by treatment
- Esophageal or gastric varices bleeding within 1 month
- Severe bleeding disorders or coagulopathy
- Large amounts of ascites, pleural, or malignant fluid
- Active infections, especially biliary tract inflammation
- Severe failure of major organs
- Allergy to PD-1/PD-L1 antibodies or similar drugs
- Uncontrolled hypertension (systolic >140 mmHg or diastolic >90 mmHg)
- Severe cardiovascular disease including ischemia, arrhythmia, low heart function
- Significant proteinuria
- Problems swallowing tablets or absorption disorders
- Other serious diseases affecting safety or study completion
- Contraindications to immunotherapy such as prior radiotherapy or targeted therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Actively Recruiting
Research Team
J
Jianbo Chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here