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Exploratory clinical study of apatinib mesylate tablets in the treatment of EGFR negative patients with non squamous non-small cell lung cancer.

Exploratory clinical study of apatinib mesylate tablets in the treatment of EGFR negative patients with non squamous non-small cell lung cancer.

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPC-16009894
Enrollment
Unknown
Registered
2016-11-17
Start date
2016-11-20
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

lung cancer

Interventions

observation group: Apatinib + cisplatin + docetaxel
control group:cisplatin + docetaxel

Sponsors

The First Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged more than 18 years old; 2. histologically confirmed advanced (B III, IV), non squamous non-small cell lung cancer with measurable disease (tumor CT scan length diameter greater than 10 mm, lymph node lesions CT scan short diameter greater than 15 mm, the slice thickness is less than 5 mm, measurable disease not received radiotherapy, freezing and other local treatment); 3. ECOG score: 0-2 points; 4. after EGFR mutation detection was confirmed as EGFR mutation negative (EGFR wild type); 5. meet the standard of blood routine examination (blood transfusion and blood products, 14 days without the use of G-CSF and other hematopoietic stimulating factor correction): (1) HB = 90 g/L; (2) ANC = 1.5 * 10^9/L; (3) PLT = 80 * 10^9/L; (4) TBIL 45 ml/min (Cockcroft-Gault formula); 6. more than the expected survival time in March; 7. women of childbearing age must be a pregnancy test in 7 days before entering the group (in serum), and the results were negative, and willing to contraception during the study period and the last 8 weeks after giving drug test using appropriate; for men, for surgical sterilization, or to contraceptive methods during the test and the last time to test drug after 8 weeks by appropriate; 8. subjects volunteered to join the study, signed informed consent, good compliance, with follow-up.

Exclusion criteria

Exclusion criteria: 1. with severe heart, liver and kidney disease, the symptoms of brain metastases failed to control; nervous, mental disorders; with serious infections; 2. people with high blood pressure and the antihypertensive drug treatment can not be reduced to the normal range (systolic mmHg >140, diastolic blood pressure mmHg >90); 3. patients with I or above coronary heart disease, arrhythmia (including QTc interval prolongation of male > 450 ms, female > 470 MS) and heart function is not complete; 4. abnormal coagulation function (INR>1.5, ULN APTT>1.5), with bleeding tendency; 5. patients with a previous history of cardiac and cerebral vascular disease or peripheral thrombosis, who are still oral thrombolytic drugs or anticoagulant drugs; 6. urinary protein positive patients (urinary protein detected by 2+ or more, or 24 hours urinary protein quantitative >1.0g); 7. according to the investigator's judgment, there are other serious hazards to patients who are safe or affected by the patient to complete the study of patients with concomitant disease; 8. patients with central nervous system metastasis; 9. pregnant or lactating women; 10. the researchers think that is not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
PFS;ORR;DCR;Qol;

Countries

China

Contacts

Public ContactQin Sida

The First Affiliated Hospital of Xi'an Jiaotong University

414565918@qq.com+86 15829916265

Outcome results

None listed

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