Clinical study of Jianpi Huayu Recipe in reducing blood hypercoagulability of advanced gastric cancer mediated by tissue factor

Phase 1

Recruiting

• Conditions: gastric cancer

• Registration Number: ITMCTR2000003513
• Lead Sponsor: Jiangsu Province Hospital of Chinese Medicine

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: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients with pathological diagnosis of Gastric cancer;
2. The TNM stage was III-IV;
3. Patients with dysfunction of blood coagulation and meet the two following criteria:
(1) PT shortening > 3s;
(2) APTT shortening > 3s;
(3) FIB > 4g/L; 4.DD > 0.5mg/l; 5.PLT > 300 * 10^9 / L;
4. Patients with criteria of TCM syndrome of blood stasis and weakened spleen and stomach;
5. Patients aged from 18 to 80 years old;
6. KPS score > 50;
7. Patients with life expectancy of at least 3 months;
8. No hemostasis, thrombolysis, anticoagulation, antiplatelet, non steroidal anti-inflammatory drugs or traditional Chinese medicine which effected of promoting blood circulation has been taken in the two weeks before admission;
9. Patients who provide written informed consent to participate in the study according to the GCP criteria.

Exclusion Criteria

1. Patients who is unable to swallow oral medications including with digestive tract obstruction and jejunostomy;
2. Patients with symptomatic brain metastasis or mental disorder;
3. Patients with severe cardiovascular disease, chronic liver disease, kidney disease or blood disease;
4. Patients with active bleeding (massive bleeding) or bleeding tendency;
5. Patients with serious uncontrolled medical diseases or acute infection;
6. Patients whose laboratory examination before enrollment is abnormal according to the following criteria: Blood routine examination: ANC < 2.0 * 109 /L, Hb < 90g/L, PLT < 80 * 10^9 /L, Renal function: Cr > 1.5 * upper normal limit (UNL); CCr<50ml/minute, liver function: TBil > 1.5 * UNL, ALT(SGPT) and AST (SGOT) > 1.5 * UNL;
7. Patients who are pregnant, nursing;
8. Patients who are substance abuse, or with clinical, mental, and social features which is interference for the study and informed consent.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
inflammatory factors(IL-1ß\IL-8\IL-10\TNF-a\GM-CSF);VEGF;Tissue Factor;

Secondary Outcome Measures

Name	Time	Method
platelet aggregation test with turbidimetry;Seven Items of Blood Coagulation;Karnofsky;complete blood count;