Actively Recruiting
Clinical Study on the Safety and Efficacy of QY-1-T in the Treatment of HBV-associated Advanced HCC
Led by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2025-05-16
9
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
Sponsors
S
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor
S
Shenzhen Zhongke Qiyuan Biotechnology Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The vast majority of liver cancers have an insidious onset and are often asymptomatic in the early stages, making early diagnosis difficult. Once diagnosed, most liver cancers have reached locally advanced stages or distant metastases, equivalent to Barcelona stage (BCLC) C-D. The tumors progress rapidly and there is a lack of effective treatments. The survival period of cancer patients is generally only 3-6 months. Cellular immunotherapy, including CAR-T and TCR-T, is considered a new hope for the treatment of cancer. The purpose of this study is to explore the safety of QY-1-T (a TCR-T targeting HBV) in the treatment of HBV-related liver cancer, and to preliminarily evaluate the efficacy of QY-1-T in patients with HBV-related advanced liver cancer.
CONDITIONS
Official Title
Clinical Study on the Safety and Efficacy of QY-1-T in the Treatment of HBV-associated Advanced HCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old, any gender
- Able and willing to voluntarily sign informed consent
- Diagnosed with advanced hepatocellular carcinoma confirmed by histopathology or cytology (BCLC stage B or C, or CNLC stage IIA/IIB and IIIA/IIIB)
- Meets one of four conditions related to prior therapy failure, recurrence, or progression after local treatment or transplantation with appropriate intervals
- Discontinued prior systemic therapy at least 2 weeks before enrollment
- Expected survival time greater than 6 months
- Has at least one measurable tumor lesion per RECIST1.1
- Positive for hepatitis B surface antigen (HBsAg) or prior HBV infection
- HLA typing showing HLA-A*11:01
- Non-cirrhosis or compensatory cirrhosis with Child-Pugh score less than 7
- Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less
- Adequate blood and biochemical lab values within specified limits
- Negative pregnancy test for women of childbearing age and agreement to use contraception
- Willingness to abstain from alcohol during the study
- Ability and willingness to comply with all treatment procedures and protocols
You will not qualify if you...
- Presence of secondary primary malignancies except treated non-melanoma skin cancers or curable carcinoma in situ
- Liver tumor load exceeding 70%
- History of organ transplantation
- Main portal vein cancer thrombus
- Moderate to severe ascites
- Positive for HIV 1 or 2, AIDS history, or syphilis antibody positive
- Decompensated cirrhosis Child-Pugh B or C (score 7-15)
- Recent significant bleeding or bleeding tendencies within 2 weeks, or serious thrombotic events within 6 months
- Uncontrolled high blood pressure (systolic >160 mmHg or diastolic >110 mmHg despite treatment)
- HBV DNA levels above 1000 IU/ml during screening
- Positive for HCV RNA
- Prior cell therapy including NK, CIK, DC, CTL, or stem cell therapy
- Concurrent anti-tumor treatments including chemotherapy, hormone therapy, or immunotherapy
- Immune checkpoint inhibitor use within 1 month
- Severe cardiac dysfunction or arrhythmias not controlled by medication
- Any medical condition that increases risk or interferes with study
- Conditions interfering with drug administration or sample collection
- History of psychotropic drug abuse or mental disorders
- Participation in other drug trials within 4 weeks before screening
- Pregnant or breastfeeding women
- Inability or unwillingness to comply with treatment procedures or protocols
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai General Hospital
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
Research Team
J
Jiang Long, MD
CONTACT
Q
Qi Li, MD
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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