colorectal cancer
Conditions
Interventions
Intervention group:Received intravenous injection of Xindilizumab and oral treatment of Furoquinib, followed by electroacupuncture treatment
Sponsors
Harbin Medical University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. fully understand the study and voluntarily sign the informed consent form; 2. aged = 18 years, = 75 years; 3. patients must be pathologically confirmed as advanced, metastatic or recurrent microsatellite stable (MSS) colorectal cancer (according to the testing criteria of each institution testing center, immunohistochemical, PCR or NGS tests can be used); 4. patients have previously received one or more treatment regimens for advanced or metastatic colorectal cancer, at least one of which includes fluorouracil; 5. ECOG performance status 0-1, and no deterioration within 7 days; 6. expected survival = 3 months; 7. blood routine: no blood transfusion or use of blood products within 14 days, no G-CSF or other hematopoietic stimulators.White blood cell count > 3000/µl, absolute neutrophil count (ANC) = 1500 cells/µl, platelet count = 75,000/µl, hemoglobin = 9.0 g/dL, left ventricular ejection fraction (LVEF) = 50%, Fridericia corrected QT interval (QTcF) < 470 milliseconds, INR = 1.5 × ULN, APTT = 1.5 × ULN; 8. aspartate aminotransferase (AST), alanine aminotransferase (ALT) = 2.5 times the upper limit of normal (ULN) (without liver metastasis), aspartate aminotransferase (AST), alanine aminotransferase (ALT) = 5 times and 3 times the upper limit of normal (ULN) (with liver metastasis), alkaline phosphatase = 2.5 times the upper limit of normal (ULN), total bilirubin = 1.5x ULN, creatinine < ULN.International normalized ratio (INR) = 1.5 × ULN and partial thromboplastin time (PTT) or activated partial thromboplastin time (APTT) = 1.5 × ULN unless therapeutic anticoagulation is administered; 9. patients receiving anticoagulants such as heparin may be included in the study if there is no previous evidence of potential abnormalities in these parameters.According to pre-dose measurements as defined by local standards of care, these two measures will be closely monitored at least weekly assessments until INR and PTT remain stable; 10.Women of childbearing age should take effective contraceptive measures; 11.Good compliance and cooperation with follow-up.
Exclusion criteria
Exclusion criteria: 1. unable to comply with the study protocol or study procedures; 2. pregnant or lactating women; 3. any factors affecting oral administration; 4. suffering from heart disease, severe skin infections, edema, scars, etc. are not suitable for electroacupuncture treatment; 5. concurrent with any of the following conditions: uncontrolled hypertension, coronary artery disease, arrhythmia and heart failure; 6. patients participated in clinical studies of other drugs within 4 weeks before enrollment; 7. alcohol or drug abuse within 4 weeks after the last clinical trial; 8. anti-infective treatment did not stop 14 days before the start of the study; 9. previously received fruquintinib, sintilimab and electroacupuncture treatment; 10.Severe uncontrolled systemic diseases, such as severe active infections; 11.Urinalysis showed urine protein = + + and confirmed 24-hour urine protein > 1.0 g; 12.Evidence or history of bleeding tendency within 2 months prior to enrollment, regardless of seriousness; active bleeding within 13.3 months; arterial/venous thrombosis within 6 months; hereditary or acquired bleeding (eg, coagulopathy) or thrombophilia; current or recent use of full-dose oral or injectable anticoagulants or thrombolytic drugs for therapeutic purposes (10 days prior to start of study treatment); surgery (except biopsy) or incomplete healing of the surgical incision within 4 weeks prior to study; aspirin (> 325 mg/day) or current or recent use of dipyridamole, clopidogrel, and sitazole (10 days prior to study); 14.Acute myocardial infarction, acute coronary syndrome, or CABG within 6 months prior to first treatment; 15.Use of systemic glucocorticoids or other systemic immunosuppressive drugs within 2 weeks prior to treatment.Have started or anticipated use of immunosuppressive medications during the trial.For inhaled corticosteroids, physiologic replacement doses are permitted; 16.Fractures or wounds that have not been healed for a long time; 17.Inactivated vaccine within 4 weeks prior to enrollment or possible during the study; 18.Other malignancies within 5 years before enrollment, except basal cell or squamous cell carcinoma of the skin after radical resection, or cervical carcinoma in situ; 19.Known immunodeficiency virus (HIV) infection or known HIV-positive patients; 20.Previous allogeneic bone marrow transplantation or organ transplantation; 21.Subjects who are allergic to the study drug or any of its adjunctive agents; 22.Clinically significant electrolyte abnormalities as judged by the investigator; 23.Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers (HBV DNA > 500 IU/mL) or HCV carriers with detectable HCV RNA may be detected.Note: Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B patients (HBV DNA < 500 IU/mL) can be included in the study; 24.Patients with bleeding tendency or bleeding disorder who are not suitable for acupuncture; 25.Previous history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis, symptomatic lung disease, or active pneumonia on chest CT scan within 4 weeks prior to study; 26.The patient had a medical history of autoimmune disease; 27.AEs not recovered to Grade 1 or lower (except alopecia areata) after previous treatment; 28.Major surgery, open biopsy, or major trauma within 28 days prior to starting study drug; 29.Unresolved toxicities above CTCAEv5.0 Grade 1 due to any prior anticanc
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 6 months/9 months/12 months progression free survival rate;Progression free survival;Disease control rate; | — |
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Countries
China
Contacts
Public ContactZheng Tongsen
Harbin Medical University Cancer Hospital
Outcome results
None listed