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

Phase 1

• Conditions: stage IV colorectal cancer

• Registration Number: ITMCTR1900002295
• Lead Sponsor: Xiyuan Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Observational study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
mPFS;