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Apatinib and Etoposide as the Maintenance Therapy in Extensive-stage Small Cell Lung Cancer After First-line Chemotherapy

NCT ID: NCT03135977

Last Updated: 2017-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2018-12-31

Brief Summary

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Although fist-line therapy with Cisplatin and etoposide(EP)or Carboplatin and etoposide(CE) has been given, patients with extensive small cell lung cancer(ED-SCLC) still relapse and the 2-year survival is extremely low. There is no standard maintenance treatment recommendation for ED-SCLC patients after the first-line therapy.Apatinib has been approved as a second-line treatment for advanced gastric cancer. Several phase III clinical studies of non small cell lung cancer, liver cancer, colorectal cancer and other tumors also showed apatinib has less toxic side effects and better patient tolerance. However, the clinical application of apatinib in small cell lung cancer is still lack of evidence-based medicine,so this clinical trial is designed to investigate the efficacy and safety of apatinib combine with etoposide as maintenance therapy in ED-SCLC patients after first-line chemotherapy in our center.

Detailed Description

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Conditions

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Extensive-stage Small Cell Lung Cancer Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Apatinib, Etoposide

Patients receive etoposide 50mg from day 1 to day 14 and apatinib 250mg/d from day 1 to day 21, repeated every 21 days until progressive Disease(PD) .

Group Type EXPERIMENTAL

Apatinib, Etoposide

Intervention Type DRUG

Patients receive etoposide 50mg from day 1 to day 14 and apatinib 250mg/d from day 1 to day 21, repeated every 21 days until progressive Disease(PD) .

Interventions

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Apatinib, Etoposide

Patients receive etoposide 50mg from day 1 to day 14 and apatinib 250mg/d from day 1 to day 21, repeated every 21 days until progressive Disease(PD) .

Intervention Type DRUG

Other Intervention Names

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VP-16

Eligibility Criteria

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Inclusion Criteria

* Histologic or cytologic diagnosis of extensive-stagesmall cell lung caner(SCLC) ,after first-line therapy
* Performance status of 0～2 on the ECOG criteria
* Expected survival is above three months
* Adequate hematologic (neutrophil count\>=1.5×109/L, hemoglobin\>=80g/L, platelets\>=80×109/L), hepatic function (aspartate transaminase (AST) \& alanine transaminase(ALT) =\<upper normal limit(UNL) x2, bilirubin level =\< UNL x 1.5)
* Patients have the ability to understand and voluntarily sign the informed consent, and allow adequate follow-up.

Exclusion Criteria

* suffered from other tumor within 5 years( Except: cervical carcinoma in situ, cured basal cell carcinoma, cured bladder epithelial tumor).
* Difficulties in taking pills (inability to swallow tablets,GI tract resection, chronic bacillary diarrhea and intestinal obstruction).
* Bleeding tendency or coagulation disorders.
* Uncontrolled hypertension (systolic pressure\>150 mmHg , or diastolic pressure\> 90 mmHg).
* Urine protein≥++, or urine protein in 24 hours≥2.0g.
* severe uncured wounds, ulcers or fracture.
* Pregnant or breast-feeding.
* Patients with epilepsy who need to take medicine (such as steroids or anti epilepsy agents).
* The researcher believe that the Patient is not suitable to participate in the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sichuan Cancer Hospital and Research Institute

OTHER

Sponsor Role lead

Responsible Party

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xionghong cai

epartment of Medical Oncology, Sichuan Cancer Hospital & Institute, Chengdu, Sichuan, PR China

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xionghong Cai, Doctor

Role: PRINCIPAL_INVESTIGATOR

Sichuan Cancer Hospital and Research Institute

Locations

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Sicchuan cancer hospital

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xionghong Cai, Doctor

Role: CONTACT

Phone: 8618036672884

Email: [email protected]

Facility Contacts

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xiaohong Cai, Doctor

Role: primary

Other Identifiers

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Ahead-SL-20170220

Identifier Type: -

Identifier Source: org_study_id