Actively Recruiting
Perioperative Risk of Immunotherapy Based Neoadjuvant and Conversion Therapy for Hepatocellular Carcinoma
Led by Qilu Hospital of Shandong University · Updated on 2024-08-26
200
Participants Needed
1
Research Sites
643 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to retrospectively collect a cohort of participants with hepatocellular carcinoma who received immunotherapy-based neoadjuvant/translational treatment. A multi-dimensional and multi-method analysis plan will be adopted. The goal is to provide solutions for better application of neoadjuvant immunotherapy and to offer better evidence for conducting prospective clinical research on hepatocellular carcinoma.
CONDITIONS
Official Title
Perioperative Risk of Immunotherapy Based Neoadjuvant and Conversion Therapy for Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent.
- Diagnosed with hepatocellular carcinoma by pathology, cytology, or clinical guidelines.
- Received immunotherapy as neoadjuvant or conversion therapy.
- Fully recovered from surgical tumor removal within 4 weeks before enrollment.
- Child Pugh liver function rating A or B (7 points or less).
- ECOG performance status score of 0 to 1.
- Expected survival time of at least 12 weeks.
- If infected with hepatitis B, willing to receive antiviral treatment during the study and be regularly monitored; if hepatitis C RNA positive, receiving antiviral treatment with liver function within CTCAE1 level elevation.
You will not qualify if you...
- Presence of other active cancers within 5 years except cured skin basal cell carcinoma or cervical carcinoma in situ.
- Uncontrollable metastases outside the liver, such as in lungs or brain.
- History or planned organ or bone marrow transplantation.
- Active or history of interstitial lung diseases requiring hormone therapy, severe lung conditions, or active tuberculosis.
- Active or history of autoimmune diseases that may recur, except controlled conditions by hormone replacement therapy.
- Uncontrolled hypertension or previous hypertensive crisis.
- Moderate to severe ascites with symptoms requiring treatment or Child Pugh score above 7.
- Heart diseases not well controlled, including significant heart failure, unstable angina, recent heart attack, serious arrhythmias, or prolonged QTc interval.
- History of spontaneous rupture of liver tumors or hepatic encephalopathy.
- Immune dysfunction such as HIV infection.
- Thrombosis or embolism within 6 months before treatment.
- Recent history of gastrointestinal bleeding or risk factors for bleeding.
- Abdominal fistulas, gastrointestinal perforation, or abscesses within 6 months before treatment.
- Severe untreated wounds, ulcers, or fractures.
- Known bleeding or clotting disorders or recent therapeutic anticoagulant use.
- Major vascular diseases within 6 months before surgery.
- Severe infections within 4 weeks before surgery or recent therapeutic antibiotic use.
- Use of immunosuppressive or systemic hormone therapy within 14 days before surgery.
- Received live attenuated vaccine within 28 days before surgery.
- Other conditions that could affect study results or safety, such as alcoholism, drug 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
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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