Actively Recruiting
A Clinical Trial Evaluating the Safety and Efficacy of Intravenous HNF4α srRNA in Treating Advanced ICC Patients
Led by Shanghai Changzheng Hospital · Updated on 2025-04-24
9
Participants Needed
1
Research Sites
85 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. The dosing regimen is planned for a second dose 14 ± 3 days post-initial treatment, followed by subsequent treatments every 28 ± 7 days, with adjustments made based on patient tolerance and therapeutic response. This is a dose escalation assay employing a i3+3 design to assess escalating HNF4α srRNA dosages: 25 μg, 50 μg, and 100 μg. Post-initial dose, a 14-day dose-limiting toxicities (DLT) observation will evaluate tolerability and safety, guiding dose adjustments or selection of the Recommended Dose (RD) for the expansion phase. Cohorts may include up to 9 participants, adjusted for safety. Drug: HNF4α srRNA, a drug specifically designed to target liver cancer cells and facilitate the expression of HNF4α. According to Amendment 1, patients who have received at least 4 cycles of HNF4α srRNA therapy and have a tumor assessment of SD (stable disease) or PD (progressive disease) per RECIST v1.1 criteria may, after a comprehensive evaluation by the investigator considering the patient's treatment history and the current safety and efficacy data of HNF4α srRNA, continue HNF4α srRNA at the same dose, or have their dose adjusted, in combination with immunotherapy, targeted therapy, or chemotherapy.
CONDITIONS
Official Title
A Clinical Trial Evaluating the Safety and Efficacy of Intravenous HNF4α srRNA in Treating Advanced ICC Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Histologically or cytologically confirmed intrahepatic cholangiocarcinoma
- Patients not suitable for surgery, liver transplantation, or ablation, or with recurrence/metastasis after surgery
- Patients who have progressed after at least one chemotherapy regimen or are unsuitable for local or systemic treatment
- Life expectancy of at least 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Males with fertility and females of childbearing potential willing to use effective contraception during the study and for six months afterward
- Females of childbearing age with a negative pregnancy test within 7 days before the first treatment dose
- Willingness and ability to provide written informed consent and comply with the study protocol
You will not qualify if you...
- Albumin less than 25 g/L, or total bilirubin more than 5 times the upper limit of normal (ULN), or AST, ALP, or ALT more than 10 times ULN
- Creatinine greater than 1.5 times ULN or creatinine clearance less than 40 mL/min
- Absolute neutrophil count less than 1.0�d7109/L, platelets less than 30�d7109/L, or hemoglobin less than 8.5 g/dL
- International normalized ratio (INR) greater than 2.3
- Poorly controlled hypertension, diabetes, serious heart or lung diseases, or serious organ dysfunction
- Received local or systemic anti-tumor treatments within 4 weeks, or chemotherapy or radiotherapy within 2 weeks unless deemed disease progression
- Incurable brain metastasis
- Prior treatment toxicities of grade 2 or higher (except hair loss or tolerable events)
- Recent complications from liver cirrhosis or hepatocellular carcinoma within 2 weeks of treatment
- Uncontrolled active infections such as lung or abdominal infections
- History of malignancy other than hepatocellular carcinoma within 5 years, except certain low-risk cancers
- Hepatitis B DNA over 500 copies/mL or hepatitis C RNA over 15 U/mL
- Positive for HIV
- Allergy to contrast agents
- Pregnant or lactating women, or women who might become pregnant
- Any condition deemed by the investigator to prevent participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Changzheng Hospital, Naval Medical University
Shanghai, Shanghai Municipality, China, 200003
Actively Recruiting
Research Team
W
Wen-Ping Xu, MD. PhD
CONTACT
W
Weifen Xie, 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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