colorectal cancer
Conditions
Interventions
Treatment group:losartan+Bevacizumab + chemotherapy (CapeOx+mXELIRI)
Sponsors
Jiangjin Central Hospital of Chongqing
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) The subjects voluntarily joined the study and signed the informed consent; 2) Age: 18-80 years old; 3) The patient was histologically confirmed as colorectal adenocarcinoma and imaging studies confirmed recurrence or metastasis; 4) Gene test confirmed RAS gene mutation; Or RAS and BRAF both wild type, the primary focus is located in the right colon; 5) No signs of intestinal obstruction; Or intestinal obstruction has been relieved after proximal colostomy surgery; 6) mCRC patients who had previously received first-line postoperative chemotherapy and failed, or were first diagnosed with advanced mCRC; 7) Activity status score: ECOG 0-2; 8) Life expectancy: more than 6 months; 9) With or without hypertension; 10) Vital organ functions meet the following requirements i. Absolute neutrophil count (ANC) =2×109/L ii. Platelets =100×109/L; iii. Hemoglobin =9g/dL; iv. Serum albumin =3g/dL; v. ALT and AST=2.5 times ULN; vi. Creatinine clearance =50mL/min; 11) Fertile female subjects should take a serum pregnancy test within 72 hours before the first dosing and prove negative, and be willing to use effective methods of contraception during the trial period until 3 months after the last dosing. For male subjects whose partner is a woman of reproductive age, effective contraception should be used during the trial and for 3 months after the last dose. Examples include double barrier methods of contraception, condoms, oral or injectable contraceptives, intrauterine devices, etc. All female patients will be considered fertile unless they have undergone natural menopause, artificial menopause, or sterilization (such as hysterectomy, bilateral adnexectomy, or irradiation of radioactive ovaries).
Exclusion criteria
Exclusion criteria: 1) There were clinically significant bleeding symptoms or definite bleeding tendencies within 3 months before enrollment, such as gastrointestinal bleeding, active bleeding, stool occult blood ++ or above at baseline, or vasculitis; 2) Subjects with clinical symptoms of untreated active brain metastases or with meninges metastases; 3) Have clinical symptoms or diseases of the heart that are not well controlled, such as: (1) NYHA2 or higher heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, (4) Clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention; 4) Known hereditary or acquired bleeding and thrombotic tendencies (such as hemophilia, coagulation disorders, thrombocytopenia, hypersplenism, etc.) or are receiving thrombolytic or anticoagulant therapy; 5) Urine routine indicates urine protein =++, or confirms 24-hour urine protein volume =1.0g; 6) Hypotensive subjects: blood pressure below 90/60mmHg; 7) Occurrence of arterial/venous thrombosis events, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc. within 6 months before enrollment; 8) Subjects with active infection; 9) Congenital or acquired immune deficiency (such as HIV infection), or active hepatitis (hepatitis B: HBsAg positive and HBV DNA=104 copy number /ml; Hepatitis C: HCV antibody positive); 10) A known or suspected allergy to the study drug or to any drug administered in connection with this trial; 11) In the investigator's judgment, the subject has other conditions that could affect the study results or cause the study to be stopped, such as substance abuse, serious illness (including mental illness such as seizures), and other medical, psychological, or social conditions that could compromise the patient's safety and compliance; 12) Gastrointestinal perforation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR(Objective response rate); | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR(Disease control rate);PFS(Progression-free survival);OS(Overall survival);security; | — |
Countries
China
Contacts
Public ContactChunrong Wu
Jiangjin Central Hospital of Chongqing
Outcome results
None listed