Safety and efficacy of Jian-Pi Bu-Shen Jie-Du-Fang decoction combined with low-dose apatinib and sergio in the treatment of stage IV colorectal cancer

Xiyuan Hospital0 个研究点开始时间: 待定最近更新: 2023年2月20日

适应症

试验速览

暂无简介。

•1. Aged 18-80 years, male or female;
•2. Pathological diagnosis of colorectal cancer;
•3. The clinical stage was stage IV;
•4. Inability to tolerate, respond to, or refuse conventional treatment;
•5. KPS=60;
•6. Expected survival 3 months;
•7. There were measurable lesions that met the RECIST 1.1 criteria;
•8. The laboratory examination meets the following requirements:
•(1) Normal blood routine;
•(2) BIL=1.5 ULNif hepatic metastases BIL= 2.5 ULN;
•(3) ALT and AST=2.5×ULNif hepatic metastases ALT and AST=5×ULN;
•(4) Endogenous creatinine clearance rate Ccr=50ml/min(Cockcroft-Gault);
•(5) Urine protein < (++)24h Urine protein quantity<1.0 g;
•9. Coagulation function was normal without active bleeding and thrombotic disease:
•(1) INR=1.5×ULN;
•(2) APTT=1.5×ULN;
•(3) Prothrombin time-international normalized ratio=1.5;
•10. Voluntary participation in the study and informed consent;
•11. Compliance is expected to be good, and the efficacy and adversereactions can be followed up according to the program requirements;
•12. The researchers believe that they can benefit from this treatment regimen.
•* Conventional treatment refers to the standard treatment methods such as surgery, radiotherapy and chemotherapy recommended by NCCN and CSCO guidelines.

•1. Concomitant with other malignant tumors;
•2. Patients with hypertension who cannot be reduced to normal range after antihypertensive drug treatment (systolic blood pressure 140 mmHg/diastolic blood pressure 90 mmHg);
•3. Having uncontrollable clinical symptoms or disease of the heart, such as
•(1) NYHA II and above heart failure;
•(2) Patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;
•(3) There are many factors affecting oral drug absorption, such as inability to swallow and intestinal obstruction.
•4. Patients at risk of bleeding include the following
•(1) Active peptic ulcer;
•(2) A history of melena and hematemesis within 3 months;
•(3) Hemoptysis occurred within one month before entering the study;
•5. Having thrombotic diseases or receiving anticoagulant drugs; Long-term anticoagulant therapy with warfarin or heparin is required, or long-term antiplatelet therapy is required (aspirin 300 mg/ day or clopidogrel 75 mg/ day);
•6. Major surgery, open biopsy or significant trauma were performed within 28 days before admission;
•7. Researchers believe that other situations are not suitable for inclusion;
•8. With serious heart, lung, liver, kidney dysfunction.

发起方

Xiyuan Hospital