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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04819516
• Other study ID #: HIFUREGONIVO2101
• Status: Recruiting
• Phase: Phase 1
• Start date: December 7, 2020
• Est. completion date: December 2025

Study information

• Verified date: March 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Ying Yuan, Ph.D & MD
• Phone: +86-13858193601
• Email: yuanying1999[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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

Drug:
• Toripalimab
Toripalimab plus regorafenib

Locations

Country	Name	City	State
China	the Second Affiliated Hospital of Medical College of Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events		3 months from baseline
Primary	Adverse events		6 months from baseline
Primary	Adverse events		9 months from baseline
Primary	Adverse events		12 months from baseline
Primary	Number of Participants With Abnormal Laboratory Values		3 months from baseline
Primary	Number of Participants With Abnormal Laboratory Values		6 months from baseline
Primary	Number of Participants With Abnormal Laboratory Values		9 months from baseline
Primary	Number of Participants With Abnormal Laboratory Values		12 months from baseline
Secondary	Number of Participants With Abnormal Tumor markers		12 months from baseline
Secondary	Number of Participants With Abnormal Tumor markers		3 months from baseline
Secondary	Number of Participants With Abnormal Tumor markers		6 months from baseline
Secondary	Number of Participants With Abnormal Tumor markers		9 months from baseline
Secondary	Disease Control Rate		From Baseline to primary completion date, about 60 months
Secondary	Progression Free Survival		From Baseline to primary completion date, about 60 months
Secondary	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
Secondary	Numeric rating scale	Numerical Rating Scale (pain measurement) minimum: 0, means no pain maximum: 10, means unbearable physical pain	12 months from baseline