Status:
UNKNOWN
Study of the Safety and Effectiveness of HIFU Combined With REGOTORI for Metastatic Colorectal Cancer
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This study intends to perform high-intensity focused ultrasound combined with REGOTORI in patients with multiline drug-resistant metastatic colorectal cancer to explore the safety and efficacy of pati...
Eligibility Criteria
Inclusion
- The subject has metastatic colorectal cancer, and the first and second-line standard treatments have failed
- There is at least one target lesion that can be treated with HIFU
- Voluntarily accept this treatment clinical research, and sign the "Subject Informed Consent"
- 18-75 years old, no gender limit
- The level of physical strength of the Eastern Cooperative Oncology Group (ECOG): PS\<=2
- The expected survival time is greater than 3 months
- No chemotherapy or radiotherapy within 21 days before enrollment
- The function of major organs is basically normal
Exclusion
- Pregnant or lactating women
- People infected with HIV, hepatitis C virus and Treponema pallidum
- There is an active infection that requires systemic treatment (such as active tuberculosis)
- Severe infection within 4 weeks before starting the study treatment
- Subjects who have received allogeneic tissue/solid organ transplantation
- The patient suffers from major vascular disease or irregular bleeding disease
- Suffer from physiological or pathological malnutrition diseases, chronic diarrhea, cachexia, etc.
- The patient has autoimmune diseases, such as (but not limited to) multiple sclerosis, systemic lupus erythematosus and inflammatory bowel disease, vitiligo
- The patient has a history of serious drug or food allergy (for example, allergy to protein)
- The patient has serious heart disease (including but not limited to: myocardial infarction, cardiomyopathy, valvular disease, malignant arrhythmia, etc.), severe liver and kidney damage, uncontrolled blood sugar and blood pressure (the subject's blood pressure, After using antihypertensive drugs, it still cannot be controlled within the normal range; fasting blood glucose is still \>10mmol/L after using antihypertensive drugs)
- The patient has uncontrollable seizures or loss of insight due to mental illness
- In the 12 months before screening, the patient has a history of drug abuse, drug abuse, and long-term alcoholism
- Within 3 months before screening, the patient is participating in other clinical studies
- Other situations that cannot participate in clinical research.
Key Trial Info
Start Date :
December 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04819516
Start Date
December 7 2020
End Date
December 1 2025
Last Update
March 29 2021
Active Locations (1)
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1
the Second Affiliated Hospital of Medical College of Zhejiang University
Hangzhou, Zhejiang, China, 310000