Clinical trial NCT04819516: 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
Overall status: RECRUITING
Phase: PHASE1
Conditions: Colorectal Cancer
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-03-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Adverse events
timeFrame: 3 months from baseline
measure: Adverse events
timeFrame: 6 months from baseline
measure: Adverse events
timeFrame: 9 months from baseline
measure: Adverse events
timeFrame: 12 months from baseline
measure: Number of Participants With Abnormal Laboratory Values
timeFrame: 3 months from baseline
measure: Number of Participants With Abnormal Laboratory Values
timeFrame: 6 months from baseline
measure: Number of Participants With Abnormal Laboratory Values
timeFrame: 9 months from baseline
measure: Number of Participants With Abnormal Laboratory Values
timeFrame: 12 months from baseline
Secondary outcomes:
measure: Number of Participants With Abnormal Tumor markers
timeFrame: 12 months from baseline
measure: Number of Participants With Abnormal Tumor markers
timeFrame: 3 months from baseline
measure: Number of Participants With Abnormal Tumor markers
timeFrame: 6 months from baseline
measure: Number of Participants With Abnormal Tumor markers
timeFrame: 9 months from baseline
measure: Disease Control Rate
timeFrame: From Baseline to primary completion date, about 60 months
measure: Progression Free Survival
timeFrame: From Baseline to primary completion date, about 60 months
measure: QoL
timeFrame: 12 months from baseline
measure: Numeric rating scale
timeFrame: 12 months from baseline
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the Second Affiliated Hospital of Medical College of Zhejiang University
state: Zhejiang
Study officials:
affiliation: The Second Affiliated Hospital of Medical College of Zhejiang University
name: Ying Yuan, Ph.D & MD
role: STUDY_CHAIR
References: