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

Primary Purpose

Colorectal Cancer

Status

Recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

high-intensity focused ultrasound therapy

Toripalimab

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

the Second Affiliated Hospital of Medical College of Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HIFU with REGOTORI

Arm Description

Outcomes

Primary Outcome Measures

Adverse events

Number of Participants With Abnormal Laboratory Values

Secondary Outcome Measures

Number of Participants With Abnormal Tumor markers

Disease Control Rate

Progression Free Survival

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.

Numeric rating scale

Numerical Rating Scale (pain measurement) minimum: 0, means no pain maximum: 10, means unbearable physical pain

Full Information

NCT ID

NCT04819516

First Posted

January 27, 2021

Last Updated

March 25, 2021

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

1. Study Identification

Unique Protocol Identification Number

NCT04819516

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Recruiting

Study Start Date

December 7, 2020 (Actual)

Primary Completion Date

December 2025 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HIFU with REGOTORI

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

high-intensity focused ultrasound therapy

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Toripalimab

Other Intervention Name(s)

Regorafenib

Intervention Description

Toripalimab plus regorafenib

Primary Outcome Measure Information:

Title

Adverse events

Time Frame

3 months from baseline

Title

Adverse events

Time Frame

6 months from baseline

Title

Adverse events

Time Frame

9 months from baseline

Title

Adverse events

Time Frame

12 months from baseline

Title

Number of Participants With Abnormal Laboratory Values

Time Frame

3 months from baseline

Title

Number of Participants With Abnormal Laboratory Values

Time Frame

6 months from baseline

Title

Number of Participants With Abnormal Laboratory Values

Time Frame

9 months from baseline

Title

Number of Participants With Abnormal Laboratory Values

Time Frame

12 months from baseline

Secondary Outcome Measure Information:

Title

Number of Participants With Abnormal Tumor markers

Time Frame

12 months from baseline

Title

Number of Participants With Abnormal Tumor markers

Time Frame

3 months from baseline

Title

Number of Participants With Abnormal Tumor markers

Time Frame

6 months from baseline

Title

Number of Participants With Abnormal Tumor markers

Time Frame

9 months from baseline

Title

Disease Control Rate

Time Frame

From Baseline to primary completion date, about 60 months

Title

Progression Free Survival

Time Frame

From Baseline to primary completion date, about 60 months

Title

QoL

Description

Time Frame

12 months from baseline

Title

Numeric rating scale

Description

Numerical Rating Scale (pain measurement) minimum: 0, means no pain maximum: 10, means unbearable physical pain

Time Frame

12 months from baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ying Yuan, Ph.D & MD

Phone

+86-13858193601

yuanying1999@zju.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ying Yuan, Ph.D & MD

Organizational Affiliation

The Second Affiliated Hospital of Medical College of Zhejiang University

Official's Role

Study Chair

Facility Information:

Facility Name

the Second Affiliated Hospital of Medical College of Zhejiang University

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ying Yuan, Ph.D & MD

Phone

+86-13858193601

yuanying1999@zju.edu.cn

12. IPD Sharing Statement

Learn more about this trial

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

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