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
N/A
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
Researchers are evaluating the effectiveness and safety of combining Transarterial Chemoembolization (TACE) with the drugs adebrelimab and bevacizumab in treating patients with unresectable hepatocellular carcinoma, a type of primary liver cancer. This Phase 2 clinical study is designed as a single-arm, prospective, and multicenter trial focusing on patients who cannot undergo surgery or radical ablation and have measurable liver tumors. Participants receive one TACE treatment, followed by doses of adebrelimab at 20 mg/kg and bevacizumab at 15 mg/kg every three weeks. The study monitors patients over a period of up to two years to assess various outcomes related to tumor response and survival. This includes examining the rate at which tumors respond to treatment, the possibility of surgical removal after therapy, and overall disease control. Throughout the study, participants will undergo regular evaluations including imaging scans to measure tumor size, laboratory tests to monitor organ function, and assessments of side effects. Researchers will track objective response rates, occurrence of adverse events, progression-free survival, and overall survival among other measures. Participants are expected to comply with follow-up visits and treatment schedules over the two-year observation period to help determine the impact of these combined therapies on liver cancer.
CONDITIONS
Brief 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 by clinical criteria or pathology
- At least one measurable lesion according to RECIST 1.1 standards
- No prior systemic treatment and unable to have 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 to 1
- Expected survival of at least 12 weeks
- If active hepatitis B infection: HBV DNA below 2000 IU/mL or 12500 copy/mL and receiving antiviral treatment
- If hepatitis C positive: receiving antiviral treatment with liver function grade CTCAE 1 or lower
- Normal main organ function meeting blood count and biochemical test standards
- Women of childbearing age must have a negative pregnancy test and use contraception during and 24 weeks after treatment; men must use contraception or be surgically sterile
- Willingness to participate voluntarily and comply with follow-up
You will not qualify if you...
- Pregnant or breastfeeding women
- Diagnosis of cholangiocarcinoma or mixed cell carcinoma
- Diffuse liver cancer
- Autoimmune diseases, organ or stem cell transplantation, or other malignant tumors except cured basal skin cell carcinoma and cervix carcinoma in situ
- Mental illness or inability to cooperate with treatment
- Participation in other clinical trials within the last 3 months
- Previous malignancies or prior targeted or 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 hormone therapy within 14 days before enrollment
- Child-Pugh liver function grade C
- Recent esophageal or gastric varices bleeding within 1 month
- Severe bleeding disorders or low platelet count below 50 x 10^9/L
- Large amounts of ascites, pleural, or malignant fluid
- Active infection, especially biliary tract inflammation
- Severe failure of major organs like liver, kidney, heart, lung, or brain
- Allergy to PD-1/PD-L1 antibodies or similar drugs
- Uncontrolled hypertension above 140/90 mmHg
- Severe cardiovascular disease or low heart function
- Significant proteinuria
- Difficulty swallowing or malabsorption conditions
- Other serious diseases that endanger safety or study completion
- Contraindications to immunotherapy including radiotherapy or targeted therapy
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 - Every 3 weeks dosing with adebrelimab and bevacizumab, continuing as per protocol
Participants receive TACE treatment once and receive adebrelimab and bevacizumab every 3 weeks.
Regular visits every 3 weeks for drug administration
Duration - Up to 2 years
Participants are monitored for safety and treatment response for up to 2 years after treatment.
Periodic visits during follow-up period
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Actively Recruiting
Research Team
J
Jianbo Chen
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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