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Tests treatment safety and results for Intrahepatic Cholangiocarcinoma
Official title A Clinical Trial Evaluating the Safety and Efficacy of Intravenous HNF4α srRNA in Treating Advanced ICC Patients
ClinicalTrials.gov ID: NCT06583993
What this study is testing
What is HNF4α srRNA?
HNF4α srRNA is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for intrahepatic cholangiocarcinoma.
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 goal of this investigator-initiated, a single-arm, open-label, pilot study is to investigate the safety, tolerability, and efficacy of intravenous HNF4α srRNA treatment in subjects with advanced Intrahepatic Cholangiocarcinoma (ICC). Condition of disease: advanced intrahepatic cholangiocarcinoma Intervention： HNF4α srRNA will be administered intravenously for the treatment of ICC.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Males or females, aged 18 years or older.
- Histologically or cytologically confirmed intrahepatic cholangiocarcinoma patients.
- Patients with intrahepatic cholangiocarcinoma not suitable for surgical resection, liver transplantation, or ablation therapy, or those with...
- Patients not suitable for local or systemic treatment, or those who have progressed after at least one chemotherapy regimen containing...
- Life expectancy of 12 weeks or more.
You likely can't join if
- Patients with any of the following criteria were excluded from participation in this study
- Inadequate liver function：Albumin (ALB) \ 5 × the upper limit of normal (ULN), or aspartate aminotransferase (AST), alkaline phosphatase (ALP), or...
- Inadequate renal function defined as creatinine \>1.5 × ULN or calculated creatinine clearance \< 40 mL/min.
- Absolute neutrophil count (ANC) \< 1.0×109/L, or Platelets \< 30×109/L, or Hemoglobin \< 8.5 g/dL.
- International normalized ratio (INR) \> 2.3.
- Poorly controlled hypertension, diabetes or other serious heart or lung diseases, or with serious dysfunction.
See the full eligibility criteria
- Males or females, aged 18 years or older.
- Histologically or cytologically confirmed intrahepatic cholangiocarcinoma patients.
- Patients with intrahepatic cholangiocarcinoma not suitable for surgical resection, liver transplantation, or ablation therapy, or those with post-surgical recurrence and/or metastasis.
- Patients not suitable for local or systemic treatment, or those who have progressed after at least one chemotherapy regimen containing gemcitabine/fluoropyrimidine/platinum, etc..
- Life expectancy of 12 weeks or more.
- people must have an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2.
- Males with fertility and females of childbearing potential are willing to use a highly effective method of contraception for the entire study period and for 6 months after study drug discontinuation. Females of...
- people who had a voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol.
- Patients with any of the following criteria were excluded from participation in this study
- Inadequate liver function：Albumin (ALB) \ 5 × the upper limit of normal (ULN), or aspartate aminotransferase (AST), alkaline phosphatase (ALP), or alanine aminotransferase (ALT) \>10 × ULN.
- Inadequate renal function defined as creatinine \>1.5 × ULN or calculated creatinine clearance \< 40 mL/min.
- Absolute neutrophil count (ANC) \< 1.0×109/L, or Platelets \< 30×109/L, or Hemoglobin \< 8.5 g/dL.
- International normalized ratio (INR) \> 2.3.
- Poorly controlled hypertension, diabetes or other serious heart or lung diseases, or with serious dysfunction.
- Patients who have received local or systemic anti-tumor treatments such as ablation, Transhepatic Arterial Chemotherapy and Embolization (TACE), local radiotherapy of the liver, immunotherapy, targeted therapy, etc...
- Patients with incurable brain metastasis.
- All toxicities related to prior locoregional or systemic anti-tumor treatments are still grade 2 or more (except for hair loss and other events that have been judged tolerable by researchers).
- Complication histories of liver cirrhosis or HCC such as gastrointestinal hemorrhage, overt hepatic encephalopathy, or refractory ascites within 2 weeks prior to the first dose of study treatment.
- Uncontrolled active infection (eg, lung infections, or abdominal infections).
- History of malignancy other than HCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year overall survival rate \> 90%), such as adequately...
- Hepatitis B virus DNA greater than 500 copies/mL, or hepatitis C virus RNA greater than 15 U/mL.
- Positive for human immunodeficiency virus (HIV).
- Allergic to contrast agents.
- Pregnant/lactating women, or women with the possibility of pregnancy.
- Any medical conditions which, in the opinion of the investigator, would preclude participation in this clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 and older. 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.