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

Study Overview
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Brief Summary
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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.

Official Title
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A Single-arm, Single-center Exploratory Study of the Safety and Effectiveness of High-intensity Focused Ultrasound Therapy Combined With REGOTORI for Metastatic Colorectal Cancer

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Procedure: high-intensity focused ultrasound therapy
* Drug: Toripalimab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIFU with REGOTORI<br> | Procedure: high-intensity focused ultrasound therapy<br>* Patients will receive high-intensity focused ultrasound therapy in local site.<br>Drug: Toripalimab<br>* Toripalimab plus regorafenib<br>* Other names: Regorafenib;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | 3 months from baseline | 
| Adverse events |  | 6 months from baseline | 
| Adverse events |  | 9 months from baseline | 
| Adverse events |  | 12 months from baseline | 
| Number of Participants With Abnormal Laboratory Values |  | 3 months from baseline | 
| Number of Participants With Abnormal Laboratory Values |  | 6 months from baseline | 
| Number of Participants With Abnormal Laboratory Values |  | 9 months from baseline | 
| Number of Participants With Abnormal Laboratory Values |  | 12 months from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Abnormal Tumor markers |  | 12 months from baseline | 
| Number of Participants With Abnormal Tumor markers |  | 3 months from baseline | 
| Number of Participants With Abnormal Tumor markers |  | 6 months from baseline | 
| Number of Participants With Abnormal Tumor markers |  | 9 months from baseline | 
| Disease Control Rate |  | From Baseline to primary completion date, about 60 months | 
| Progression Free Survival |  | From Baseline to primary completion date, about 60 months | 
| QoL | Quality of life is assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30. It will be evaluated at Screening, Tumor Assessment Visit and End of Treatment visit. | 12 months from baseline | 
| Numeric rating scale | Numerical Rating Scale (pain measurement) minimum: 0, means no pain maximum: 10, means unbearable physical pain | 12 months from baseline |