Actively Recruiting
A Clinical Trial Evaluating the Safety and Efficacy of Intravenous HNF4α SrRNA in Treating Metastatic CRC Patients
Led by Shanghai Changzheng Hospital · Updated on 2025-04-24
9
Participants Needed
1
Research Sites
94 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial is a single-arm, open-label, exploratory first-in-human clinical study designed to evaluate the safety and tolerability of HNF4α srRNA injection in patients with locally unresectable or metastatic colorectal cancer, and to preliminarily explore its effectiveness in treating metastatic colorectal cancer.
CONDITIONS
Official Title
A Clinical Trial Evaluating the Safety and Efficacy of Intravenous HNF4α SrRNA in Treating Metastatic CRC Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Histologically confirmed colorectal cancer that is unresectable or metastatic
- Patients unsuitable for or intolerant to standard systemic therapy, or with disease progression after standard therapy including chemotherapy and targeted therapies
- Patients with confirmed deficient mismatch repair or high microsatellite instability treated with immune checkpoint inhibitors but with disease progression
- Presence of measurable target lesions according to RECIST 1.1 criteria
- Life expectancy of at least 12 weeks
- Eastern Cooperative Oncology Group Performance Status of 0 to 2
- Males with fertility and females of childbearing potential willing to use highly effective contraception during the study and for 6 months after treatment
- Negative serum pregnancy test within 7 days prior to first treatment for females of childbearing age
- Willingness and ability to provide written informed consent and comply with study procedures
You will not qualify if you...
- Recurrence or metastasis within 6 months after standard adjuvant chemotherapy and no standard systemic therapy received
- Current intestinal obstruction, perforation, bleeding, or high risk of these conditions
- Liver function abnormalities: serum bilirubin > 3× ULN or AST, ALP, ALT > 5× ULN
- Renal impairment: creatinine > 1.5× ULN or creatinine clearance < 40 mL/min
- Low blood counts: ANC < 1.5×10^9/L, platelets < 50×10^9/L, or hemoglobin < 9.0 g/dL
- International normalized ratio (INR) > 2.0
- Confirmed brain metastases
- Poorly controlled hypertension, diabetes, serious heart or lung disease, or serious dysfunction
- Anti-tumor treatments within 4 weeks or radiation within 3 weeks, except for disease progression
- Prior treatment toxicities still grade 2 or higher (except tolerable events like hair loss)
- Uncontrolled active infections
- History of malignancy other than colorectal cancer within 5 years, except certain low-risk cancers
- Active autoimmune disease requiring systemic treatment within past 2 years
- Use of systemic corticosteroids >10 mg/day or immunosuppressive drugs within 14 days before first dose
- History of organ transplantation
- Hepatitis B DNA > 500 IU/ml or hepatitis C RNA > 100 IU/ml
- Positive for HIV
- Pregnant or lactating women, or women who may become pregnant
- Participation in other drug trials within 4 weeks
- Any condition deemed unsuitable by the investigator for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Changzheng Hospital，Naval Medical University
Shanghai, Shanghai Municipality, China, 200003
Actively Recruiting
Research Team
B
Beifang Ning, 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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