Colorectal cancer
Conditions
Interventions
None:HIFU,US-guided HIFU procedure was performed using a JC-200
HIFU system (Chongqing Haifu Medical Technology Co, Ltd.,
Chongqing, China).
None:PD-1 Inhibitor,after HIFU treatment 3-5 days,patients began to received PD-1 inhibitors,consideration of drug economy and drug availability, domestic PD-1 inhibitors can be selected, and there is
None:fruquintinib,after HIFU treatment 3-5 days,patients received oral fruquintinib 5 mg once daily on a 21-day on–7-day off schedule until disease progression or intolerance to adverse events,fruquin
Sponsors
Suining Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1)Aged 18-70 years old; (2)Histological diagnosis of adenocarcinoma of the colon or rectum, exclude other tissue types, patients with a primary resection or no resection can be enrolled; (3)at least one radiographic diagnosis of liver metastasis, Such as CT, MRI, PET-CT, And as assessed by the surgeon, Or the patient is unwilling to undergo surgical treatment; (4)detecting the expression of four MMR enzymes (MLH 1, MSH 2, MSH 2, PMS 2) by immunohistochemistry, Detection MMR, the status is pMMR, Or MSI by polymerase chain reaction, with the status of MSS; (5)performance score (ECOG PS) of 0-1; (6)disease progression after at least second-line standard treatment, Chemotherapy regimens must include fluoropyrimidines, oxaliplatin, and irinotecan, Or any combination of the above chemotherapy drugs, Subjects who withdraw from standard therapy due to unacceptable toxicity will also be allowed to participate in the study. The subject may have received bevacizumab and / or cetuximab) / panitumumab therapy (if KRAS wild type); (7)In liver metastatic lesions, after ultrasound localization, it was determined that at least one lesion was available for HIFU treatment; (8)Liver lesion lesions = 5; (9)At least one lesion throughout the body can be measured according to version RECIST 1.1; (10)adequate bone marrow, liver and kidney function; (11)life expectancy is over 12 weeks; (12)Voluntary participation in this trial, and signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1)exclusion of radiotherapy, microwave, RF, freezing and HIFU in the past; (2)extensive radiotherapy within 4 weeks, Or local radiotherapy within 2 weeks; (3)previous history of other types of cancer; (4)heart disease including congestive heart failure, unstable angina pectoris, myocardial infarction, Arrhythmia requiring antiarrhythmic therapy; (5)uncontrolled hypertension (after the use of antihypertensive drugs, Systolic blood pressure still greater than 150 mmHg or diastolic blood pressure greater than 100 mmHg); (6)thrombotic or embolic events, Such as cerebrovascular accident (including transient ischemic attack, hematencephalon, Cerebral infarction) and pulmonary embolism occurred within 6 months before the start of the study; (7)any history of brain metastasis or currently known brain metastasis; (8)interstitial lung disease, Persistent signs and symptoms with informed consent; (9)the patient has received anti-PD-1 / PD-L1 immunotherapy or other immune experimental drugs; (10)any major surgery within 4 weeks prior to enrollment; (11)active gastrointestinal gastric and duodenal ulcer, ulcerative colitis or uncontrolled bleeding; (12)an immunosuppressant or systemic hormone 14 days before the start of the study for> 10mg / day (dose prednisone or other therapeutic hormone); (13)a known history of severe allergy to any monoclonal antibody or anti-angiogenic target drug; (14)severe psychological or mental disorders that may affect compliance to the study; (15)history of severe autoimmune disease; (16)other severe comorbidities; (17)contraindications to HIFU treatment; (18)not assessed by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;progression-free survival;Disease control rate;Overall survival; | — |
Countries
China
Contacts
Public ContactFan Yang
Suining Central Hospital
Outcome results
None listed