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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

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

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900022673
Enrollment
Unknown
Registered
2019-04-21
Start date
2019-05-01
Completion date
Unknown
Last updated
2019-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

stage IV colorectal cancer

Interventions

Sponsors

Xiyuan Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
mPFS;

Countries

China

Contacts

Public ContactYufei Yang

Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine

yyf93@vip.sina.com+86 010-62835436

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 12, 2026