Study on the combined scheme of Quxie Capsule in the third-line treatment of metastatic colorectal cancer and the characteristics of the dominant populatio
- Conditions
- colorectal cancer
- Registration Number
- ITMCTR2200006487
- Lead Sponsor
- XiyuanHospital of CACMS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
(1) 18-85 years old, regardless of gender;
(2) It was pathologically diagnosed as colorectal cancer and its clinical stage was stage IV;
(3) Patients who intend to receive the standard third-line treatment of Western medicine or have begun to receive the third-line treatment (no more than 14 days);
(4) ECoG 0-2 points;
(5) Estimated survival period = 3 months;
(6) Measurable lesions meeting RECIST 1.1 standard;
(7) No strict center of gravity, abnormal lung, liver and kidney functions;
(8) Normal coagulation function, no active bleeding and thrombosis;
(9) Voluntarily join the study and sign the informed consent form;
(10) It is expected that the patients with good compliance can follow up the efficacy and adverse reactions according to the protocol requirements.
(11) The researchers believe that they can benefit from this treatment.
(1) Patients with brain metastases with clinical symptoms;
(2) Combined with other untreated malignant tumors;
(3) Patients with dmmr by immunohistochemistry or MSI-H by gene detection;
(4) Patients with uncontrollable hypertension who cannot be reduced to the normal range after antihypertensive drug treatment (systolic blood pressure = 140mmhg/ diastolic blood pressure = 90mmHg);
(5) Suffering from uncontrolled cardiac clinical symptoms or diseases, such as a.nyha II and above heart failure; b. Unstable angina pectoris; c. Myocardial infarction occurred within 1 year; d. Patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;
(6) There are many factors that affect the absorption of oral drugs, such as inability to swallow and intestinal obstruction;
(7) Patients at risk of bleeding, including the following: A. active peptic ulcer lesions; b. Those with history of melena and hematemesis within 3 months; c. Hemoptysis occurred within 1 month before entering the study;
(8) Patients with thrombotic diseases or receiving anticoagulant drugs; Long term anticoagulation therapy with warfarin or heparin or long-term antiplatelet therapy (aspirin = 300 mg/ day or clopidogrel = 75 mg/ day) is required;
(9) Major surgery, open biopsy or significant trauma were performed within 28 days before enrollment;
(10) Patients who will or are participating in other clinical trials;
(11) Other situations that the researcher thinks are not suitable for inclusion.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method overall survival(OS);
- Secondary Outcome Measures
Name Time Method progression-free survival(PFS);Disease control rate(DCR);Objective remission rate(ORR);