NCT03651219

Mesylate Apatinib Combined With Irinotecan in Treatment of Recurrent Small Cell Lung Cancer

Mesylate Apatinib Combined With Irinotecan in Treatment of Recurrent Small Cell Lung Cancer: A Randomized Controlled Clinical Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Beijing Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to evaluate the safety and efficacy of apatinib mesylate tablets and chemotherapy drug Irinotecan in treatment of recurrent SCLC stage IIIB\&IV patients. It is a randomized controlled clinical trial.

Detailed description

Apatinib mesylate is a new inhibitor of VEGFR-2 tyrosine kinase targeting the intracellular ATPbinding site of the receptor. This research needs participants satisfied following criteria: 1. Aged between 18 and 70； 2. Locally advanced/metastatic small lung cancer (IIIB/IV) confirmed by pathology with measurable lesions； 3. Patients who was treated by platinum chemotherapy drugs（including sensitive recurrency and resistant recurrency） 4. ECOG：0-2； 5. the function of primary organs is normal. 6. Patients voluntarily entered the study and signed informed consent form (ICF). The primary goal of this research choose ORR, DCR and adverse effects as main curative effect criteria. PFS, OS and QoL as secondary curative effect criteria.

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Apatinib	Apatinib Mmesylate tablets 250mg/d, po, there's totally 4-6 cycles(21days per cycle)
DRUG	Irinotecan	Irinotecan 80mg/m2 d1, d8, vi, there's totally 4-6 cycles(21days per cycle)

Timeline

• Start date: 2018-09-08
• Primary completion: 2019-08-08
• Completion: 2020-08-08
• First posted: 2018-08-29
• Last updated: 2018-08-29