NCT03547804

A Prospective, Single-center, One-arm Clinical Study of Apatinib Combined With Chemotherapy for Pretreated Patients With Advanced Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: The First Hospital of Jilin University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

At present, with the increasing intensities of the tobacco industry and air pollution in China, the incidence and mortality of lung cancer have become the most important issue that threatens human health.Over the past two decades, the treatment of SCLC still stays in the mode of treatment based on radiotherapy and chemotherapy. This is a prospective, single-center, one-arm clinical study designed to evaluate the efficacy and safety of apatinib plus chemotherapy for second-line and above treatment of advanced SCLC. 30 patients will receive apatinib 500mg qd orally, if the patient has a grade 3/4 adverse reaction during apatinib treatment, it can be reduced to apatinib 250mg qd orally.The dose was later reduced from 500 mg to 250 mg per day based on a recommendation of the principal investigator to reduce the adverse events. Chemotherapeutic agents are limited to irinotecan or docetaxel alone.The primary outcome endpoint was progression-free survival

Conditions

• Small-cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Apatinib	500 mg qd/250mg
DRUG	chemotherapy	Chemotherapeutic agents are limited to irinotecan or docetaxel alone.

Timeline

• Start date: 2018-05-31
• Primary completion: 2019-10-25
• Completion: 2020-09-01
• First posted: 2018-06-06
• Last updated: 2020-12-01

Locations

1 site across 1 country: China