Study of the Safety and Effectiveness of HIFU Combined With REGOTORI for Metastatic Colorectal Cancer

Zhejiang University

Status and phase

Enrolling

Phase 1

Conditions

Colorectal Cancer

Treatments

Procedure: high-intensity focused ultrasound therapy

Drug: Toripalimab

Study type

Interventional

Funder types

Other

Identifiers

NCT04819516

HIFUREGONIVO2101

Details and patient eligibility

About

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 patients. Patients receive HIFU local treatment combined with REGOTORI treatment, and receive corresponding clinical data collection at different follow-up points, including necessary data from various laboratories, CT/MRI, and immune function tests that are exactly the same as before surgery collection.

Enrollment

10 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.