Actively Recruiting
Adebrelimab, Camrelizumab Plus Apatinib as First-line Therapy in Patients With Advanced Hepatocellular Carcinoma
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2024-02-21
52
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, single-arm, phase Ib/II trial . The objective of this study is to evaluate the efficacy and safety of adebrelimab, camrelizumab plus apatinib as first-line therapy in patients with advanced hepatocellular carcinoma
CONDITIONS
Official Title
Adebrelimab, Camrelizumab Plus Apatinib as First-line Therapy in Patients With Advanced Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be 18 years old or older and willing to sign informed consent
- Diagnosed with advanced or metastatic solid tumor or advanced hepatocellular carcinoma by accepted criteria
- Patients with hepatocellular carcinoma not suitable for surgery or local treatment, or progressed after such treatments
- Able to provide fresh or archived tumor tissue samples and pathology reports
- Completed any local treatment at least 4 weeks before baseline imaging with recovery from toxic effects
- No prior systemic treatment for hepatocellular carcinoma
- At least one measurable lesion meeting RECISTv1.1 size criteria
- Child-Pugh liver function classification A or B
- Eastern Cancer Cooperative Group (ECOG) performance status score 0 to 2
- Expected survival time of at least 12 weeks
- Normal or acceptable function of major organs as specified by blood counts, biochemical tests, coagulation, thyroid function, and heart function
- If active hepatitis B or C infection, must meet specific viral load and treatment requirements
- Fertile women must use effective contraception or abstain from sex and have a negative pregnancy test before treatment
- Male participants with partners of childbearing age must agree to effective contraception and not donate sperm during the study period
You will not qualify if you...
- Diagnosed with cholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma, or fibrolamellar carcinoma
- Presence of other active malignancies within 5 years except certain localized tumors
- History of or scheduled organ or bone marrow transplantation
- Received experimental drugs within 28 days before starting study treatment
- Moderate to severe symptomatic ascites or pleural/pericardial effusion
- History or risk of gastrointestinal bleeding within 6 months before treatment
- Abdominal fistula, gastrointestinal perforation, or abscess within 6 months
- Known bleeding disorders or recent use of full-dose anticoagulants
- Use of certain antiplatelet drugs within 10 days before treatment
- Thrombosis or embolism within 6 months before treatment
- Uncontrolled or significant heart disease including recent myocardial infarction or arrhythmias
- Uncontrolled hypertension or history of hypertensive crisis
- Major vascular diseases within 6 months before treatment
- Recent major surgery within 4 weeks before treatment
- Gastrointestinal absorption issues or intestinal obstruction symptoms within 6 months
- Evidence of unexplained pneumoperitoneum
- Central nervous system metastases
- History of hepatic encephalopathy
- Active or history of significant lung diseases or active tuberculosis
- Active autoimmune disease or history of autoimmune disease with possible recurrence
- Recent use of immunosuppressants or systemic steroids
- Use of strong CYP3A4/CYP2C19 inducers or inhibitors within 14 days before treatment
- History of severe allergy to monoclonal antibodies or anti-angiogenesis drugs
- Severe infection within 4 weeks before treatment
- Congenital or acquired immunodeficiency
- Co-infection with hepatitis B and C
- Prior anti-PD-1/PD-L1 immunotherapy or apatinib treatment
- Recent live attenuated vaccine within 28 days or expected within 60 days after treatment start
- Other conditions that may affect study results or patient safety as judged by the researcher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China, 510220
Actively Recruiting
Research Team
L
Lei Zhang, PhD
CONTACT
Y
Yin Long
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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