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

Phase 1

Recruiting

• Conditions: Colorectal Cancer
• Interventions: Procedure: high-intensity focused ultrasound therapy; Drug: Toripalimab

• Registration Number: NCT04819516
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-07
• Study First Submitted: 2021-01-27
• Status Verified: 2021-03
• Study First Submitted QC: 2021-03-25
• Last Update Submitted: 2021-03-25
• Study First Posted: 2021-03-29
• Last Update Posted: 2021-03-29
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HIFU with REGOTORI	high-intensity focused ultrasound therapy	-
HIFU with REGOTORI	Toripalimab	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Abnormal Laboratory Values	12 months from baseline
Adverse events	12 months from baseline

Secondary Outcome Measures

Name	Time	Method
Numeric rating scale	12 months from baseline	Numerical Rating Scale (pain measurement) minimum: 0, means no pain maximum: 10, means unbearable physical pain
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	12 months from baseline	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.

Trial Locations

Locations (1)

the Second Affiliated Hospital of Medical College of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China