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Status unknownNCT03135977Updated Dec 7, 2017

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

A Phase 2 interventional study of Apatinib, Etoposide in Extensive-stage Small Cell Lung Cancer and Lung Cancer, sponsored by Sichuan Cancer Hospital and Research Institute. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-07.

Sponsored by Sichuan Cancer Hospital and Research Institute · Phase 2, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Dec 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
36
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Extensive-stage Small Cell Lung Cancer
  • Lung Cancer
03

In context

Small Cell Lung Carcinoma

1,234 studies on the registry are indexed under Small Cell Lung Carcinoma; 350 are open to participants now.

This study's planned enrollment of 36 is below the median of 56 across 1,058 interventional studies indexed under Small Cell Lung Carcinoma.

Browse Small Cell Lung Carcinoma studies →

Lead sponsor

Sichuan Cancer Hospital and Research Institute is the lead sponsor of 64 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
36 participants (estimated)

Study arms

  • Experimental
    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) .

    Drug: Apatinib, Etoposide

Interventions

  • DrugApatinib, Etoposide

    Drug pages: 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) .

    Also known as: VP-16

06

What researchers measure

Primary outcomes

  1. Progression-free survival

    The first day of treatment to the date that disease progression is reported

    Time frame: 6 months

Secondary outcomes

  1. Overall survival

    the first day of treatment to death or last survival confirm date

    Time frame: up to 24 months

  2. Duration of Response

    Duration of response is defined as time from the date of the first observed hematologic improvement to the date of the first subsequent documented disease progression or relapse

    Time frame: up to 24 months

  3. Tumor response rate

    The ratio between the number of responders and number of patients assessable for tumor response.

    Time frame: Time Frame: 3 month

  4. Quality of Life (QoL) questionnaire

    in cancer patients and survivors with dermatologic conditions. This is a nontherapeutic and nondiagnostic protocol to obtain quality of life assessments from cancer patients and survivors who have dermatologic conditions, whether related to cancer therapies, or directly related to the primary cancer diagnosis. Data will be collected by using one or more dermatology-specific QoL instruments based on the underlying skin condition/s.

    Time frame: up to 24 months

07

Study locations

1 of 1 sites recruiting
  • Sicchuan cancer hospital
    Chengdu, Sichuan 610000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03135977
Lead sponsor
Sichuan Cancer Hospital and Research Institute
Responsible party
xionghong cai (epartment of Medical Oncology, Sichuan Cancer Hospital & Institute, Chengdu, Sichuan, PR China, Sichuan Cancer Hospital and Research Institute) — Principal investigator
First posted
May 2, 2017
Start date
Mar 1, 2017
Primary completion
Dec 2018 (estimated)
Completion
Dec 2018 (estimated)
Last update
Dec 7, 2017

Study contacts

Xionghong Cai, Doctor
Contact
xionghong_cai@hotmail.com
8618036672884
Xionghong Cai, Doctor
principal investigator · Sichuan Cancer Hospital and Research Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Apatinib · Etoposide

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