Status:
RECRUITING
A Clinical Trial Evaluating the Safety and Efficacy of Intravenous HNF4α srRNA in Treating Advanced ICC Patients
Lead Sponsor:
Shanghai Changzheng Hospital
Conditions:
Intrahepatic Cholangiocarcinoma
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
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 I...
Eligibility Criteria
Inclusion
- 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.
- Subjects 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 childbearing age, including premenopausal females and within 2 years after menopause, must have a negative serum pregnancy test result within 7 days prior to the first dose of study treatment.
- Subjects who had a voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol.
Exclusion
- Patients with any of the following criteria were excluded from participation in this study
- Inadequate liver function：Albumin (ALB) \< 25 g/L, or total bilirubin \> 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., within 4 weeks, or chemotherapy, other trial drugs, or radiotherapy of metastatic lesions within 2 weeks, except for treatment regimens assessed as disease progression according to RECIST v1.1.
- 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 treated early gastric carcinoma, carcinoma in situ of the cervix, non-melanoma skin carcinoma, or localized prostate cancer.
- 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.
Key Trial Info
Start Date :
November 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT06583993
Start Date
November 7 2024
End Date
July 1 2026
Last Update
April 24 2025
Active Locations (1)
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1
Shanghai Changzheng Hospital, Naval Medical University
Shanghai, Shanghai Municipality, China, 200003