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

NCT03547804 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2020-12-01

No results posted yet for this study

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

DRUG

Apatinib

500 mg qd/250mg

DRUG

chemotherapy

Chemotherapeutic agents are limited to irinotecan or docetaxel alone.

Sponsors & Collaborators

  • The First Hospital of Jilin University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-31
Primary Completion
2019-10-25
Completion
2020-09-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03547804 on ClinicalTrials.gov