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

NCT ID: NCT04819516

Last Updated: 2021-03-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-07
• Study Completion Date: 2025-12-31

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HIFU with REGOTORI

Group Type: EXPERIMENTAL

high-intensity focused ultrasound therapy

Intervention Type: PROCEDURE

Patients will receive high-intensity focused ultrasound therapy in local site.

Toripalimab

Intervention Type: DRUG

Toripalimab plus regorafenib

Interventions

high-intensity focused ultrasound therapy

Patients will receive high-intensity focused ultrasound therapy in local site.

Intervention Type: PROCEDURE

Toripalimab

Toripalimab plus regorafenib

Intervention Type: DRUG

Other Intervention Names

Regorafenib

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Ying Yuan, MD

Professor, Department of Medical Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ying Yuan, Ph.D & MD

Role: STUDY_CHAIR

The Second Affiliated Hospital of Medical College of Zhejiang University

Locations

the Second Affiliated Hospital of Medical College of Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ying Yuan, Ph.D & MD

Role: CONTACT

yuanying1999@zju.edu.cn

+86-13858193601

Facility Contacts

Ying Yuan, Ph.D & MD

Role: primary

yuanying1999@zju.edu.cn

+86-13858193601

Other Identifiers

HIFUREGONIVO2101

Identifier Type: -

Identifier Source: org_study_id