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A clinical trial for apatinib combination with nab-paclitaxel /cisplatin in the treatment of NSCLC

A clinical trial for apatinib combination with nab-paclitaxel /cisplatin in the treatment of NSCLC

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900023657
Enrollment
Unknown
Registered
2019-06-05
Start date
2019-06-03
Completion date
Unknown
Last updated
2019-06-11

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

Conditions

non small cell lung cancer

Interventions

Case series:Apatinib 250mg Po qd nab-paclitaxel: 100mg/m2 iv d1, 8, 15 cisplatin: 75mg/m2 d1 q3w, 4-6 cycles

Sponsors

Tangshan People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years old man or female; 2. Pathologically diagnosed with NSCLC; 3. Imageology diagnosed with locally advanced/metastatic or recurrent (stage IIIB - IV); 4. Histological or cytologic confirmed wild type of epidermal-growth-factor receptor (EGFR); 5. None previous chemotherapy or targeted therapy.(NOTE: neoadjuvant and/or adjuvant therapy is allowed which is completed before 6 months.); 6. None previous radiotherapy. If received radiation therapy, least 4 weeks have elapsed from the completion of radiation treatment, and the acute toxicity from radiation treatment had been recover; irradiated lesion is not including measurable lesions unless documented progress after radiation; 7. At least one measurable lesion (measuring=10mm on spiral CT scan, satisfying the criteria in RECIST1.1); 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; 9. Life expectancy greater than or equal to 3 months; 10. Major organ function has to meet the following certeria: (1) For results of blood routine test (without blood transfusion within 14 days): HB=100g/L; ANC=1.5×10^9/L; PLT=75×10^9/L; (2) blood biochemical test: TBIL45 ml/min(per the Cockcroft-Gault formula); 11. Women of childbearing age must have contraceptive measures or have test pregnancy (serum or urine) enroll the study before 7 days, and the results must be negative, and take the methods of contraception during the test and the last to have drugs after 8 weeks; 12. Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.

Exclusion criteria

Exclusion criteria: 1. Patients with symptomatic central nervous system metastases; 2. Have high blood pressure and antihypertensive drug treatment can not control (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); 3. Patients who suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QT interval male = 450 ms, female = 470 ms). Grade III-IV cardiac insufficiency according to New York Heart Association(NYHA) criteria or echocardiography check: left ventricular ejection fraction (LVEF) 1.5 ULN, APTT > 1.5 ULN), with bleeding tendency; 6. History of psychiatric drugs abuse and can't quit or patients with mental disorders; 7. A variety of factors influencing oral drugs (such as unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc); 8. According to the investigator's judgment, people with concomitant diseases that seriously endanger the safety of the patient or affect the patient's completion of the study; 9. Patients with pregnant or planning a pregnancy; 10. Patients with other malignant tumors within 5 years (except for the treated skin basal cell carcinoma and cervical carcinoma in situ); 11. Less than 4 weeks from the last clinical trial; 12. The researchers think inappropriate.

Design outcomes

Primary

MeasureTime frame
Progression free survival ;safety;

Secondary

MeasureTime frame
Disease control rate ;Overall survival;Objective response rate;

Countries

China

Contacts

Public ContactGuogui Sun
guogui_sun2013@163.com+86 13315532983

Outcome results

None listed

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