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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: high-intensity focused ultrasound therapy; Drug: Toripalimab

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ying Yuan, ph.D & MD; Phone Number: +86-13858193601; Email: yuanying1999@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • The Second Affiliated Hospital of Medical College of Zhejiang University
      • Contact: Ying Yuan, ph.D & MD; Phone Number: +86-13858193601; Email: yuanying1999@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Study Chair: Ying Yuan, Ph.D & MD, The Second Affiliated Hospital of Medical College of Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2020
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: January 27, 2021
• First Submitted That Met QC Criteria: March 25, 2021
• First Posted (Actual): March 29, 2021

Study Record Updates

• Last Update Posted (Actual): March 29, 2021
• Last Update Submitted That Met QC Criteria: March 25, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: HIFUREGONIVO2101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No