Appatinib Combined With S-1 in the Treatment of Small Cell Lung Cancer

A Single-center, Single-arm Exploratory Clinical Study of Apatinib Mesylate Tablets Combined With S-1 in the Treatment of Second-line or More Advanced Small Cell Lung Cancer

To evaluate the objective remission rate and disease control rate of apatinib mesylate tablets combined with S-1 in the treatment of advanced small cell lung cancer patients with failed or dangerous radiotherapy or chemotherapy

Study Overview

Status

Unknown

Intervention / Treatment

Detailed Description

Lung cancer is one of the malignant tumors with the highest morbidity and mortality in the world. Small cell lung cancer accounts for about 15-20% of all lung cancer. Although the initial treatment is sensitive to radiotherapy and chemotherapy, patients with small cell lung cancer are prone to recurrence and metastasis in the early stage, and ultimately lead to death due to the lack of effective treatment after the disease progresses. Patients with relapsed small cell lung cancer had a poor prognosis; untreated patients had only two to three months of expected survival.Therefore, it is urgent to find a method to treat SCLC.

Two single-arm phase II clinical studies on small cell lung cancer have evaluated the efficacy and safety of bevacizumab combined with first-line chemotherapy for extensive SCLC. Two phase II single arm studies showed good efficacy and safety. Apatinib and bevacizumab are both antiangiogenic agents. S-1 is a new oral fluoropyrimidine anticancer agent, but S-1 has shown a high remission rate for metastatic NSCLC and relapsed NSCLC.

In view of the good efficacy and tolerability of oral chemotherapeutic agent S-1, and the lack of suitable targeted drugs after NGS treatment in relapsed S LCL patients after previous multithreaded treatment, this clinical trial is to study the efficacy and safety of combination of anti-angiogenesis drugs and S-1 in patients with failed or dangerous SCLC after second-line or more radiotherapy and chemotherapy.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Recruiting
        • Tianjin Medical University Cancer Institute and Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. The informed consent of the patient must be obtained before any research steps are carried out.
  2. Confirmation of SCLC: Histological diagnosis or two imaging diagnoses must be made.
  3. Late stage of SCLC, failure of second-line radiotherapy and chemotherapy or dangerous type of patients
  4. Male or female subjects > 18 years old, < 75 years old
  5. There are objective lesions that can be measured by CT.
  6. The activity status of KPS was above 80 points.
  7. Within 14 days before admission, the bone marrow, liver and kidney functions detected by the central laboratory should meet the following laboratory data requirements:

    Hemoglobin ≥ 9.0 g/dl; absolute neutrophil count (ANC)1,500 /mm3 ; platelet count ≥ 50,000 /ul; total bilirubin < 2 mg/dL (3 mg/dL, Child B); ALT and AST < 5-fold normal value upper limit; alkaline phosphatase < 4-fold normal value upper limit; PT > 50% or PT-INR < 2.3, or greater than the control value < 6 seconds.

  8. For subjects taking warfarin, the subjects were closely monitored at least once a week until the INR measurement of the subjects was stable at the time of each administration according to the local treatment standards.
  9. The upper limit of normal serum creatinine < 1.5 times is
  10. For pregnant women, the results of serum pregnancy test must be negative within 14 days before the start of treatment.
  11. All male and female patients participating in this study must adopt reliable contraceptive measures during the trial and within two week.

Exclusion Criteria:

  1. KPS < 60 points, or expected survival < 3 months.
  2. Severe cardiovascular diseases .
  3. Uncontrollable hypertension .
  4. History of human immunodeficiency virus (HIV) infection .
  5. Active clinical severe infections (Grade 2, NCI-CTCAE Version 3.0) .
  6. Epilepsy patients requiring medication (e.g. steroids or antiepileptic drugs) .
  7. History of allogeneic organ transplantation .
  8. Patients with signs of hemorrhage or history of disease.
  9. Patients undergoing renal dialysis.
  10. Chronic obstructive pulmonary emphysema .
  11. Gastrointestinal bleeding within 30 days before admission .
  12. Patients have a history of esophageal varices bleeding, and subsequently did not receive effective treatment or treatment to prevent recurrence of bleeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Apatinib and S-1 group
apatinib 250 mg PO qd; S-1 40 mg PO in the morning and 60 mg PO in the evening; 14 days in combination, 21 days in a cycle.
Other Names:
  • apatinib mesylate tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate(ORR)
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Disease Control Rate (DCR)
Time Frame: one year
one year

Other Outcome Measures

Outcome Measure
Time Frame
Progression free survival (PFS)
Time Frame: one year
one year
Overall survival (OS)
Time Frame: one year
one year
Quality of life (QoL)
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ning bo Liu, MD, Tianjin Medical University Cancer Institute & Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

October 1, 2019

Primary Completion (ANTICIPATED)

December 1, 2020

Study Completion (ANTICIPATED)

December 1, 2021

Study Registration Dates

First Submitted

October 15, 2019

First Submitted That Met QC Criteria

October 15, 2019

First Posted (ACTUAL)

October 16, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 16, 2019

Last Update Submitted That Met QC Criteria

October 15, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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