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

NCT04819516 | Unknown Phase 1

• 1 other identifier: HIFUREGONIVO2101
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (8)

• 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

Study Arms (1)

HIFU with REGOTORI

EXPERIMENTAL

Procedure: high-intensity focused ultrasound therapy; Drug: Toripalimab

Interventions

high-intensity focused ultrasound therapy PROCEDURE

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

HIFU with REGOTORI

Toripalimab DRUG

Toripalimab plus regorafenib

Also known as: Regorafenib

HIFU with REGOTORI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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"
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

the Second Affiliated Hospital of Medical College of Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Extracorporeal Shockwave Therapy; toripalimab; regorafenib

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Ying Yuan, Ph.D & MD

  The Second Affiliated Hospital of Medical College of Zhejiang University

  STUDY CHAIR

Central Study Contacts

Ying Yuan, Ph.D & MD

CONTACT

+86-13858193601; yuanying1999@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Medical Oncology

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: March 29, 2021
• Study Start: December 7, 2020
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 29, 2021

Record last verified: 2021-03

Locations

CN (1)