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A prospective, randomized, controlled, multicenter clinical study of adjuvant therapy with apatinib combined with chemotherapy for locally advanced gastric cancer (T3-4aN+M0)

A prospective, randomized, controlled, multicenter clinical study of adjuvant therapy with apatinib combined with chemotherapy for locally advanced gastric cancer (T3-4aN+M0)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038900
Enrollment
Unknown
Registered
2020-10-09
Start date
2019-01-31
Completion date
Unknown
Last updated
2021-01-05

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

Conditions

Locally advanced gastric cancer

Interventions

experimental group:Dexamethasone+S-1++Apatinib
control group:Dexamethasone+S-1

Sponsors

The First Affiliated Hospital of Suzhou University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. The age of the patients ranged from 18 to 75 years; 2. Patients with gastric adenocarcinoma confirmed by histopathology and / or cytology and with locally advanced gastric cancer (t3-4an + M0); 3. Patients with ECoG score of 0-1; 4. Patients without previous anti-tumor therapy (radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.); 5. Patients with an estimated survival time of more than 6 months; No other patients with coronary heart disease can be controlled within half a year; 7. The subjects with normal function of main organs should meet the following requirements: (1) Blood routine examination should meet the following requirements: HGB >= 90g/L ANC >= 1.5 x 10^9/L PLT >= 100 x 10^9/L (2) Biochemical tests should meet the following standards: Bil = 50ml / min (Cockcroft Gault formula) four weeks before admission, ECG was basically normal, and there was no heart disease with obvious clinical symptoms; 8. Patients without other uncontrollable benign diseases before enrollment, such as lung, liver, kidney, infection, etc; 9. Patients who volunteered to join the study and signed the informed consent form (ICF).

Exclusion criteria

Exclusion criteria: 1. Patients with hypertension who can not be reduced to normal range after antihypertensive drug treatment (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); 2. Patients with severe cardiovascular diseases in the past: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmia (including QTc interval >= 450 ms for male and >= 470 MS for female); cardiac insufficiency of grade III-IV according to NYHA standard, or left ventricular ejection fraction (LVEF) 1.0g); 4. Patients with known HER2 positive ( or HER2 borderline results were excluded and confirmed as positive by FISH); patients with unknown HER2 Yin and Yang could be included in the study group; 5. Patients who the researchers think may have bleeding risk; 6. Long term use of aspirin, clopidogrel and other antiplatelet drugs, or warfarin and other anticoagulants; 7. Patients with abnormal coagulation function, with bleeding tendency.

Design outcomes

Primary

MeasureTime frame
DFS;

Countries

China

Contacts

Public ContactZhou Xiaojun

The First Affiliated Hospital of Soochow University

chowxj@126.com+86 13701411001

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026