Actively Recruiting
Study on the Therapeutic Effect of Different Infusion Times of Tislelizumab on Postoperative High-risk Hepatocellular Carcinoma
Led by Sir Run Run Shaw Hospital · Updated on 2025-11-24
33
Participants Needed
1
Research Sites
106 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Study on the therapeutic effect of different infusion times on tislelizumab in high-risk postoperative hepatocellular carcinoma
CONDITIONS
Official Title
Study on the Therapeutic Effect of Different Infusion Times of Tislelizumab on Postoperative High-risk Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old.
- Confirmed hepatocellular carcinoma diagnosis by histology or cytology.
- Barcelona Clinical Liver Cancer (BCLC) stage A-B with curative tumor resection.
- No extrahepatic metastasis or adjacent organ invasion before surgery.
- Meet at least one high-risk recurrence criterion: tumor >5cm, microvascular invasion positive, presence of sub lesions, or surgical margin <1cm.
- No recurrence and no systemic treatment for HCC during one month postoperative follow-up.
- Child Pugh liver function score of 5-6 points, grade A.
- Eastern Cancer Collaboration Group (ECOG) physical fitness score ≤ 1.
- Organ function within required levels before first medication use.
- Women capable of pregnancy must use effective contraception during the study and 120 days after last dose; negative pregnancy test before first dose.
- Men capable of reproduction must use effective contraception during the study and 120 days after last dose.
- If infected with HBV or HCV, must meet specific treatment and viral load conditions.
- Expected lifespan of at least 6 months.
- Voluntarily agree to participate and sign informed consent form.
You will not qualify if you...
- Diagnosis of non-hepatocellular carcinoma.
- Recurrence within one month after surgery.
- Previous anti-tumor treatments for liver cancer (chemotherapy, radiotherapy, ablation, interventional, targeted therapy, immunotherapy) except diagnostic biopsies.
- Untreated hepatitis B virus DNA >2500 copies/ml or hepatitis C virus RNA >1000.
- Long-term systemic hormone therapy (≥10 mg prednisone/day) or other immunosuppressive therapy.
- Significant bleeding or bleeding tendency within 3 months or ongoing thrombolytic/anticoagulant therapy.
- Complete intestinal obstruction or incomplete obstruction requiring treatment.
- Active severe infections including tuberculosis without complete treatment.
- History or risk of active immunodeficiency or autoimmune disease or long-term steroid use.
- Uncontrolled diabetes or severe lung disease excluding recovered radiation pneumonia.
- Clinically significant cardiovascular diseases or uncontrolled hypertension.
- Receiving renal replacement therapy.
- Allergic reactions to any investigational drug components.
- Other malignancies within past 5 years except certain cured cancers.
- Pregnant or lactating women or those refusing contraception.
- Vulnerable groups including mental illness, cognitive impairment, critically ill patients.
- Investigator judgment deeming patient unsuitable for study participation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine (Qingchun Campus) 3 Qingchun Road East, Shangcheng District, Hangzhou, Zhejiang, China
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
M
Mingyu Chen
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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