Actively Recruiting
A Clinical Trial Assessing the Safety and Efficacy of Intravenous HNF4α SrRNA for the Treatment of Patients With Metastatic Colorectal Cancer
Led by Shanghai Changzheng Hospital · Updated on 2025-04-24
9
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are exploring the safety and tolerability of intravenous HNF4α srRNA injections in patients with colorectal cancer that cannot be removed by surgery or has spread to other parts of the body. This early-phase clinical trial also aims to gather preliminary information about how well this treatment might work for metastatic colorectal cancer. The study focuses on patients who have limited treatment options due to disease progression or intolerance to standard therapies. Participants will receive HNF4α srRNA through intravenous injections, with the second dose given about two weeks after the first, followed by treatments every four weeks. The dose may be adjusted based on patient response and side effects, starting from one of three dose levels (25, 50, or 100 micrograms). Some patients initially receiving only HNF4α srRNA may later receive immunotherapy alongside this treatment, depending on their medical history and safety assessments. During the study, patients will be monitored for safety and treatment effects for about two years. Researchers will assess tumor response using imaging criteria and measure patient-reported outcomes and tumor biomarkers in the blood. Regular evaluations will include physical exams, laboratory tests, and safety assessments. The study will also track overall survival and how long any positive treatment responses last, providing important information about the treatment's impact over time.
CONDITIONS
Brief 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
- Unsuitable for or unable to tolerate standard systemic therapy, or disease progression after standard chemotherapy and targeted therapies
- Patients with deficient mismatch repair or high microsatellite instability treated with immune checkpoint inhibitors and showing disease progression
- Presence of measurable target lesions according to RECIST v1.1 criteria
- Life expectancy of at least 12 weeks
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
- Willingness to use effective contraception during the study and for 6 months after discontinuation if of childbearing potential
- Ability and willingness to provide informed consent and comply with study procedures
You will not qualify if you...
- Recurrence or metastasis within 6 months after stopping adjuvant chemotherapy without receiving standard systemic therapy
- Current or high risk of intestinal obstruction, perforation, or bleeding
- Liver function abnormalities exceeding specified limits (bilirubin >3x ULN, AST/ALT/ALP >5x ULN)
- Renal impairment with creatinine >1.5x ULN or clearance <40 mL/min
- Low blood counts (neutrophils <1.5x10⁹/L, platelets <50x10⁹/L, hemoglobin <9.0 g/dL)
- Elevated INR >2.0
- Presence of brain metastases
- Poorly controlled serious heart, lung, hypertension, or diabetes conditions
- Recent anti-tumor treatments within 3-4 weeks except for those with disease progression
- Ongoing moderate or severe toxicities from prior treatments
- Active uncontrolled infections
- History of other malignancies within 5 years except low-risk cases
- Active autoimmune disease requiring systemic treatment in past 2 years
- Use of systemic corticosteroids or immunosuppressants before treatment
- History of organ transplantation
- Active hepatitis B or C viral infection above thresholds
- HIV positive status
- Pregnant or breastfeeding women
- Participation in other drug trials within 4 weeks
- Any other condition deemed unsuitable by the investigator
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 14 ± 3 days for second dose, then every 28 ± 7 days; duration varies by participant
Participants receive intravenous HNF4α srRNA treatment for metastatic colorectal cancer. The second treatment occurs approximately 14 days after the initial dose, followed by subsequent treatments every 28 days, with adjustments based on tolerance and therapeutic effect. Some participants may receive combination immunotherapy after initial treatment cycles.
Multiple visits for each treatment administration, including initial dose, second dose around 2 weeks later, and follow-up doses every 4 weeks
Duration - Up to 2 years
Participants undergo post-treatment safety assessments and monitoring after completing treatment cycles, including evaluation of treatment tolerability and efficacy over time.
Visits as scheduled for safety and efficacy assessments during follow-up period
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
W
Weifen Xie, MD. PhD
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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