Actively Recruiting
Adjuvant Adebrelimab Plus Apatinib for Participants With HCC at High-risk of Recurrence After Curative Resection
Led by Qilu Hospital of Shandong University · Updated on 2024-08-01
30
Participants Needed
1
Research Sites
148 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-center, single-arm, open-label clinical study to evaluate the efficacy and safety of Adebrelimab plus Apatinib as adjuvant therapy in hepatocellular carcinoma (HCC) participants who are at high risk of recurrence after curative resection.
CONDITIONS
Official Title
Adjuvant Adebrelimab Plus Apatinib for Participants With HCC at High-risk of Recurrence After Curative Resection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily participate and sign informed consent.
- Diagnosed with hepatocellular carcinoma by pathology, cytology, or clinical guidelines.
- Underwent radical surgery to remove tumor within 4 to 12 weeks before enrollment.
- Fully recovered from surgery at least 4 weeks before enrollment.
- Have high risk factors for cancer recurrence such as multiple tumors, tumor size over 5 cm, poor tumor cell differentiation, close surgical margin (≤1 cm), microvascular invasion, lymph node involvement, or abnormal tumor markers.
- Child Pugh liver function score of A or B (≤7 points) within 7 days before randomization.
- ECOG performance status score of 0 or 1 within 7 days before randomization.
- No prior systemic anti-tumor treatment for hepatocellular carcinoma.
- Expected to live at least 12 weeks.
- Main organ functions meet specific blood, liver, kidney, coagulation, and urine protein levels within 7 days before randomization.
- If infected with hepatitis B or C virus, willing to receive antiviral therapy and monitoring during the study.
- Women of childbearing potential agree to use contraception during study and have negative pregnancy test before treatment.
- Not breastfeeding at study start.
You will not qualify if you...
- Have other types of liver cancer such as hepatobiliary carcinoma, sarcomatoid HCC, combined hepatocellular-cholangiocarcinoma, or fibrolamellar carcinoma.
- Have other active cancers within 5 years except certain skin or cervical cancers.
- Have uncontrolled cancer spread outside the liver (e.g., lung or brain metastases).
- Previously received local liver cancer treatments like TACE, TAE, HAIC, or TARE.
- Have had or plan to have organ or bone marrow transplantation.
- Have active or history of lung disease requiring treatment, severe lung damage, or active pneumonia.
- Have active autoimmune diseases or history of autoimmune disease that may recur, except well-controlled conditions.
- Have uncontrolled high blood pressure or history of hypertensive crisis.
- Have moderate to severe ascites or pleural/pericardial effusions.
- Have serious heart conditions or recent heart attack.
- History of spontaneous liver tumor rupture or hepatic encephalopathy.
- Immune system dysfunction such as HIV infection.
- Recent thrombosis or embolism within 6 months.
- Recent or high risk of gastrointestinal bleeding.
- Recent abdominal fistula, perforation, or abscess within 6 months.
- Severe wounds, ulcers, or untreated fractures.
- Known bleeding or clotting disorders.
- Recent use of full-dose blood thinners except low-dose aspirin or low molecular weight heparin.
- Major vascular disease requiring surgery within 6 months.
- Severe infections within 4 weeks or recent therapeutic antibiotics use.
- Known allergies to study drugs or similar medications.
- Recent use of immunosuppressive drugs or systemic steroids.
- Recent or planned use of live vaccines around treatment period.
- Recent participation in other experimental drug studies.
- Other factors judged by researchers that may affect study safety or results, including substance abuse, serious illnesses, or social factors.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Actively Recruiting
Research Team
T
Tao Li, Dr
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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