Apatinib in Combination With Docetaxel for Patients With Advanced NSCLC

NCT ID: NCT03411967

Last Updated: 2018-01-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2021-12-01

Brief Summary

In order to explore a new treatment strategy for patients with failed NSCLC platinum-containing double-drug therapy, this study was to investigate the clinical efficacy of apatinib in combination with docetaxel for patients with advanced NSCLC after failure of platinum-based regime

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

apatinib combine with docetaxel

Docetaxel, 60 mg / m2, d1, iv + apatinib 500mg, po, qd

Group Type: EXPERIMENTAL

Apatinib

Intervention Type: DRUG

apatinib mesylate tablets 500mg, po, qd, continued until the next cycle, taking on an empty stomach (daily taken at the same time), every 3 weeks For one cycle, a total of 4 to 6 cycles of treatment, apatinib has been taken until the disease progresses, intolerable toxicity.

Docetaxel

Intervention Type: DRUG

Docetaxel, 60 mg / m2, d1, iv ,every 3 weeks For one cycle, a total of 4 to 6 cycles of treatment

Interventions

Apatinib

apatinib mesylate tablets 500mg, po, qd, continued until the next cycle, taking on an empty stomach (daily taken at the same time), every 3 weeks For one cycle, a total of 4 to 6 cycles of treatment, apatinib has been taken until the disease progresses, intolerable toxicity.

Intervention Type: DRUG

Docetaxel

Docetaxel, 60 mg / m2, d1, iv ,every 3 weeks For one cycle, a total of 4 to 6 cycles of treatment

Intervention Type: DRUG

Other Intervention Names

Aitan

Eligibility Criteria

Inclusion Criteria

1. ECOG 0-2;

2. Expected survival of not less than 12 weeks;

3. The first line of platinum-containing chemotherapy, pathologically confirmed IIIB, IV non-small cell lung cancer, with measurable lesions (according to the RECIST 1.1 standard, CT lesion tumor diameter ≥ 10mm, lymph node lesion CT scan diameter ≥ 15mm, measurable lesions have not received radiotherapy, local treatment such as freezing)

4. The main organs function properly

5. Women of childbearing age must have had reliable contraception or have had a pregnancy test (serum or urine) within 7 days prior to enrollment with a negative result and are willing to take appropriate measures 8 weeks after and during the last administration of the test drug contraception. In the case of males, consent is to be given to contraception or surgical sterilization 8 weeks after and during the last administration of the test drug;

6. Participants volunteered to join the study and signed informed consent form, with good compliance and follow-up.

Exclusion Criteria

1. Imaging (CT or MRI) showed tumor lesions away from the large blood vessels ≤ 5mm, or the presence of invasive central local blood vessels of the central tumor; or showed the presence of significant lung empty or necrotic tumors;

2. Uncontrolled hypertension (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg, despite optimal drug therapy);

3. Has the following cardiovascular disease: Myocardial ischemia or myocardial infarction with grade II or higher, poorly controlled arrhythmia (including QTc intercourse men ≥ 450ms, women ≥ 470ms); NYHA class III-IV cardiomyopathy, Or cardiac ultrasound examination prompted left ventricular ejection fraction (LVEF) <50%;

4. Hemoptysis (INR> 1.5 or Prothrombin Time (PT)> ULN + 4 seconds or APTT> 1.5ULN) with bleeding tendency or undergoing thrombolytic or anticoagulant therapy;

5. In the first 2 months before enrollment, there is obvious slightly blood, or daily hemoptysis volume of 2.5ml or more;

6. Within 3 months prior to enrollment, significant clinically significant bleeding symptoms or definite bleeding tendencies such as gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood ++ at baseline, and above, or vasculitis;

7. Incidence of arterial / venous thrombosis within the first 12 months of enrollment such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism;

8. Known hereditary or acquired bleeding and thrombophilia (eg hemophilia, coagulopathy, thrombocytopenia, hypersplenism, etc);

9. Factors that significantly affect the absorption of oral drugs, such as non-swallowing, chronic diarrhea and intestinal obstruction;

10. Urine routine urinary protein ≥ ++, or confirmed 24-hour urinary protein content ≥ 2.0g;

11. Previous or concurrent with other unhealed malignancies, except for those having had a cure for cutaneous basal cell carcinoma, carcinoma of the cervix, and superficial bladder cancer;

12. Pregnant or lactating women; Reproductive patients who are unwilling or unable to take effective contraception;

13. The investigators determine other situations that may affect clinical research and outcome decisions.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Zigong No.1 Peoples Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

132100694 132100694, M.D.

Role: PRINCIPAL_INVESTIGATOR

Zigong No.1 People's Hospital

Central Contacts

Jun Yan, M.D.

Role: CONTACT

13210069400@163.com

868132100694

Other Identifiers

APTN-L201712

Identifier Type: -

Identifier Source: org_study_id