Actively Recruiting
Tislelizumab Combined With Huaier Granule as First-line Treatment for Unresectable Hepatocellular Carcinoma
Led by Tongji Hospital · Updated on 2026-05-12
94
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a single-arm prospective clinical trial that enrolled 94 patients with unresectable hepatocellular carcinoma(HCC) who received first-line treatment with tislelizumab combined with Huaier granule. By comparing the objective response rate (ORR) and other data with those from the historical Rational 301 study, the study aims to explore the efficacy and safety of tislelizumab combined with Huaier granule as a first-line treatment for unresectable HCC, as well as its potential to improve patients' quality of life and alleviate HCC-related symptoms.
CONDITIONS
Official Title
Tislelizumab Combined With Huaier Granule as First-line Treatment for Unresectable Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 618 years at the time of signing the informed consent form
- Histologically confirmed diagnosis of hepatocellular carcinoma
- BCLC stage C, or BCLC stage B disease unsuitable for locoregional therapy or progressed after locoregional therapy, not eligible for curative treatment
- No prior systemic therapy for hepatocellular carcinoma
- At least one measurable lesion according to RECIST v1.1 that meets specific criteria regarding prior treatment and progression
- Child-Pugh class A liver function within 7 days before randomization
- ECOG performance status 0 or 1
You will not qualify if you...
- Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or mixed hepatocellular-cholangiocarcinoma
- Tumor thrombus involving the main portal vein or inferior vena cava
- Prior local liver therapy or immunotherapy within 28 days before enrollment
- Use of traditional Chinese medicine or patent drugs for cancer control within 14 days before enrollment
- Grade 2 or higher hepatic encephalopathy at screening or in medical history
- Pericardial effusion, uncontrolled pleural effusion, or clinically significant ascites at screening
- History of severe hypersensitivity to monoclonal antibodies
- Evidence of portal hypertension with bleeding varices during screening or within 6 months before randomization
- Unresolved toxicities from prior anticancer therapy except alopecia
- Hemorrhagic or thrombotic disease within 6 months before screening or anticoagulant therapy requiring INR monitoring
- History of active malignancy within 2 years before screening except the hepatocellular carcinoma under study or certain treated local cancers
- Known central nervous system metastases or leptomeningeal disease at screening
- Active or history of immunodeficiency or autoimmune disease with risk of recurrence
- Need for systemic corticosteroids over 10 mg/day prednisone or similar within 14 days before screening
- History of interstitial lung disease or non-infectious pneumonia unless radiation-induced
- Severe chronic or active infections requiring systemic therapy at screening excluding viral hepatitis
- Medical conditions posing risks for study treatment or complicating adverse event interpretation
- History of allogeneic stem cell or organ transplantation; receipt of live vaccine within 4 weeks before randomization
- Major surgery within 28 days before randomization
- Female patients who are lactating
AI-Screening
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Trial Site Locations
Total: 1 location
1
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, No. 1095, Jiefang Avenue, Wuhan 430030, Hubei, China
Wuhan, Hubei, China, 430030
Actively Recruiting
Research Team
Q
Qi Cheng, MD, PhD
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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