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Tests treatment safety and results for Liver Cancer
Official title Clinical Study on the Safety and Efficacy of QY-1-T in the Treatment of HBV-associated Advanced HCC
ClinicalTrials.gov ID: NCT06251115
What this study is testing
What is QY-1-T?
QY-1-T is an investigational medicine, being studied as a potential treatment for liver cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- people aged 18-75 years old (male or female)
- The subject voluntarily participate and have the ability to sign the informed consent independently
- Patient with advanced hepatocellular carcinoma (HCC) confirmed by histopathology or cytology (BCLC stage B and C, or CNLC stage IIA/IIB and...
- Prior systemic therapy should be discontinued for at least 2 weeks prior to enrollment
- The expected survival time is more than 6 months
You likely can't join if
- The presence of a secondary primary malignancy, except in the following cases: a. Non-melanoma treated by excision, such as basal cell skin cancer...
- Liver tumor load exceeds 70%
- Co-transplanters
- Main portal vein cancer thrombus
- Moderate to severe ascites
- Human immunodeficiency virus (HIV) 1 or 2 positive or acquired immunodeficiency syndrome (AIDS) history, treponema pallidum antibody positive
See the full eligibility criteria
- people aged 18-75 years old (male or female)
- The subject voluntarily participate and have the ability to sign the informed consent independently
- Patient with advanced hepatocellular carcinoma (HCC) confirmed by histopathology or cytology (BCLC stage B and C, or CNLC stage IIA/IIB and IIIA/IIIB). One of the following four conditions applies:a. Patients with...
- Prior systemic therapy should be discontinued for at least 2 weeks prior to enrollment
- The expected survival time is more than 6 months
- The subject has at least one tumor lesion that can be measured according to RECIST1.1
- Hepatitis B virus surface antigen (HBsAg) positive or previous positive history
- The HLA typing of peripheral blood was HLA-A\ 11:01
- Non-cirrhosis or compensatory cirrhosis Child-Pugh \< 7 score
- ECOG scoring standard ≤1
- Blood routine and blood biochemical indicators: a. white blood cells ≥3×10\^9/L. b. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤5× upper limit of normal (ULN). c. Serum total bilirubin...
- Female people of childbearing age, whose serum pregnancy tests must be negative, and all people must agree to take effective contraceptive measures during the test
- Subject agrees to abstain from alcohol during the study
- The subject is willing and able to follow all treatment procedures and protocols
- The presence of a secondary primary malignancy, except in the following cases: a. Non-melanoma treated by excision, such as basal cell skin cancer. b. curable carcinoma in situ, such as cervical, bladder or breast cancer
- Liver tumor load exceeds 70%
- Co-transplanters
- Main portal vein cancer thrombus
- Moderate to severe ascites
- Human immunodeficiency virus (HIV) 1 or 2 positive or acquired immunodeficiency syndrome (AIDS) history, treponema pallidum antibody positive
- Decompensated cirrhosis Child-Pugh B or C (7-15 points)
- Clinically significant bleeding symptoms or definite bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, hereditary or acquired bleeding and thrombosis tendency (such as hemophilia...
- Have high blood pressure that cannot be effectively controlled, i.e. systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 110 mmHg after antihypertensive treatment
- Serum HBV DNA≥1000 IU/ml during screening (HBV positive for transplant donors of primary liver cancer patients), antiviral treatment can be performed according to the actual situation before admission
- HCV RNA positive
- Prior cell therapy, such as but not limited to NK, CIK, DC, CTL, stem cell therapy
- Concurrent treatment with other anti-tumor therapies, including cytotoxic chemotherapy, hormone therapy and immunotherapy
- Use of immune checkpoint inhibitors within 1 month
- Patient with Grade III or IV cardiac dysfunction, arrhythmias that cannot be controlled by drugs or QTc interval \> 450ms for men and \> 470ms for women according to the NYHA grading criteria
- Any other medical conditions that may increase people' risk or interfere with study results
- Has any condition that interferes with drug administration and study sample collection
- Those who have a history of psychotropic drug abuse and cannot abstain or have a history of mental disorders
- Participate in other drug clinical studies within 4 weeks before screening
- Pregnant or lactating women
- Failure to follow or cooperate with relevant treatment procedures and protocols during the study period
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.