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Clinical study for Fu-Zheng-Jie-Du method combined with apatinib in the treatment of advanced gastric cancer experienced radiochemotherapy and failed

Clinical study ofClinical study for Fu-Zheng-Jie-Du method combined with apatinib in the treatment of advanced gastric cancer experienced radiochemotherapy and failed

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800019521
Enrollment
Unknown
Registered
2018-11-16
Start date
2017-10-01
Completion date
Unknown
Last updated
2018-11-19

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

Conditions

Gastric Cancer

Interventions

Group 2:Apatinib Mesylas combine with Xiaoyan Tang
Group 1:Apatinib 500 mg q.d.

Sponsors

First Affilicated Hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years old, male or female; 2. The histological and / or cytological diagnosis of late gastric cancer; 3. surgery and / or radiotherapy and chemotherapy treatment failed for late gastric cancer; 4. ECOG PS: 0-2 minutes 5. major organs functioning properly, meet the following requirements: (1) blood tests, subject to (not transfusion within 14 days): HB=90g/L; ANC =1.5×10^9/L; PLT =80×10^9/L; (2) biochemical tests must meet the following criteria: BIL <1.5 times the upper limit of normal (ULN); ALT and AST <2.5 × ULN; if liver metastases, the ALT and AST <5 × ULN; Serum Cr=1 × ULN, creatinine clearance rate =50ml / min (Cockcroft-Gault formula); 6. The expected survival =3 months; 7. The treating physician plans to use the APA imatinib mesylate tablets therapy; 8. The patient voluntarily joined the study, and informed consent (ICF); 9. Women of childbearing age must be enrolled in the 7 days before a pregnancy test (serum or urine) results were negative, and the voluntary during the observation period and after the last administration for Nepalese Apa sheet 8 weeks using appropriate methods of contraception; for men, surgical sterilization should be, or agreed during the observation period and after the last administration for Nepalese Apa sheet 8 weeks using appropriate methods of contraception.

Exclusion criteria

Exclusion criteria: 1. suffering from hypertension, the antihypertensive drug therapy can not be reduced to the normal range (systolic blood pressure> 140 mmHg / diastolic blood pressure> 90 mmHg), with =level II of coronary heart disease, arrhythmia (including QTc interval prolongation men> 450 ms, female> 470 ms) and heart failure; 2. With a variety of factors influence oral absorption (such as inability to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction); 3. Special Note: The patient has a risk of gastrointestinal bleeding can not be enrolled, including the following: (1) with active peptic ulcer lesions and fecal occult blood (+); with black stools; (2) 3 months, vomiting a history; (3) for fecal occult blood (+) - and the primary gastric tumor lesions did not undergo surgery, the need for endoscopy, such as gastric ulcer, and the treating physician believes it may cause bleeding lesions; 4. coagulopathy (INR> 1.5 × ULN, APTT> 1.5 × ULN), have bleeding tendencies; 5. The transfer of the central nervous system with symptoms; 6. A pregnant or lactating women; 7. Other treating physicians considered unsuitable for patients included.

Design outcomes

Primary

MeasureTime frame
PFS;The rate of advers reactions;

Secondary

MeasureTime frame
os;ORR;DCR;

Countries

China

Contacts

Public ContactJia Yingjie

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

yingjie_jia@126.com+86 022-27986556

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026