Actively Recruiting
An Open-Label, Single Arm Study to Evaluate Adebrelimab Plus Apatinib as Adjuvant Therapy in Hepatocellular Carcinoma Patients at High Risk of Recurrence After Surgery
Led by Qilu Hospital of Shandong University · Updated on 2024-08-01
30
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of Adebrelimab and Apatinib as an additional treatment for people with hepatocellular carcinoma (HCC) who have a high risk of cancer returning after surgery. This Phase 2, single-center, open-label study focuses on assessing the safety and effectiveness of this treatment approach to improve survival and quality of life. The study includes a mid-term analysis at 6 months after enrolling 30 participants to review recurrence-free survival and overall survival rates. Participants will receive Adebrelimab at a dose of 1200 mg every 3 weeks combined with daily Apatinib 250 mg for the first 6 months or 8 treatment cycles. After this initial phase, Adebrelimab alone will be continued every 3 weeks for up to 2 years during the maintenance phase. The study follows a single-arm design without a placebo or comparison group. Throughout the study, participants will be monitored regularly for cancer recurrence and survival for up to 24 months, focusing on the recurrence-free survival rate as the primary outcome. Additional assessments include overall survival and time to recurrence over a 3-year period. Safety and liver function will be closely evaluated through clinical visits, laboratory tests, and imaging. Participants will be followed for up to three years to assess long-term outcomes and treatment effects.
CONDITIONS
Brief 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 agree to participate and sign informed consent
- Diagnosed with hepatocellular carcinoma by pathology or clinical guidelines
- Underwent radical liver tumor resection surgery 4 to 12 weeks before enrollment
- Fully recovered from surgery within 4 weeks before enrollment
- High risk of cancer recurrence based on tumor size, number, differentiation, margins, vascular invasion, lymph node involvement, or abnormal biomarkers
- Child Pugh liver function score A or B (7 points or less) within 7 days before randomization
- ECOG performance status score 0 or 1 within 7 days before randomization
- No prior systemic anti-tumor treatment for hepatocellular carcinoma
- Expected survival time at least 12 weeks
- Adequate blood counts and organ function within 7 days before randomization
- If hepatitis B or C positive, willing to receive antiviral treatment and regular monitoring
- Women of childbearing potential agree to contraception and negative pregnancy test before treatment
- Not breastfeeding
You will not qualify if you...
- Diagnosed with other liver cancer types like hepatobiliary carcinoma or sarcoma-like hepatocellular carcinoma
- Active other malignant tumors within 5 years except certain cured skin or cervical cancers
- Uncontrolled metastases outside the liver such as lung or brain
- Prior local treatments like TACE, TAE, HAIC, or TARE
- History or plan for organ or bone marrow transplantation
- Current or past interstitial lung diseases requiring hormone treatment
- Active autoimmune diseases or history of autoimmune conditions that may recur
- Poorly controlled hypertension or history of hypertensive crisis
- Moderate to severe ascites or significant pleural or pericardial effusion
- Heart diseases including heart failure, recent myocardial infarction, arrhythmias needing treatment, or abnormal QTc
- History of spontaneous liver tumor rupture or hepatic encephalopathy
- Immune dysfunction such as HIV infection
- Recent thrombosis or embolism events within 6 months
- History or risk of recent gastrointestinal bleeding or ulcers
- Recent abdominal fistulas, perforation, or abscess within 6 months
- Severe unhealed wounds, active ulcers, or untreated fractures
- Known bleeding or clotting disorders or recent use of full-dose anticoagulants
- Major vascular diseases needing surgical repair within 6 months
- Severe infections or recent use of therapeutic antibiotics
- Allergies to study drugs or similar monoclonal antibodies
- Recent immunosuppressive or systemic hormone therapy
- Recent live vaccine treatment or planned during study
- Recent experimental drug treatments
- Other serious illnesses, substance abuse, or social factors affecting safety or study results
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 - The first 6 months or 8 cycles of treatment, followed by a maintenance phase up to 2 years
Participants receive Adebrelimab plus Apatinib as adjuvant therapy after surgery to reduce the risk of cancer recurrence.
Visits every 3 weeks for drug administration during both initial and maintenance phases
Duration - Up to 3 years
Participants are monitored for recurrence-free survival, overall survival, and time to recurrence after treatment ends.
Periodic visits for assessments up to 3 years
Trial Site Locations
Total: 1 location
1
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Actively Recruiting
Research Team
T
Tao Li, Dr
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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