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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Patients will receive high-intensity focused ultrasound therapy in local site.
Toripalimab plus regorafenib
the Second Affiliated Hospital of Medical College of Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGAdverse events
Time frame: 3 months from baseline
Adverse events
Time frame: 6 months from baseline
Adverse events
Time frame: 9 months from baseline
Adverse events
Time frame: 12 months from baseline
Number of Participants With Abnormal Laboratory Values
Time frame: 3 months from baseline
Number of Participants With Abnormal Laboratory Values
Time frame: 6 months from baseline
Number of Participants With Abnormal Laboratory Values
Time frame: 9 months from baseline
Number of Participants With Abnormal Laboratory Values
Time frame: 12 months from baseline
Number of Participants With Abnormal Tumor markers
Time frame: 12 months from baseline
Number of Participants With Abnormal Tumor markers
Time frame: 3 months from baseline
Number of Participants With Abnormal Tumor markers
Time frame: 6 months from baseline
Number of Participants With Abnormal Tumor markers
Time frame: 9 months from baseline
Disease Control Rate
Time frame: From Baseline to primary completion date, about 60 months
Progression Free Survival
Time frame: 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.
Time frame: 12 months from baseline
Numeric rating scale
Numerical Rating Scale (pain measurement) minimum: 0, means no pain maximum: 10, means unbearable physical pain
Time frame: 12 months from baseline
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