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

Primary Purpose

Small Cell Lung Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Apatinib S-1

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring apatinib S-1, Advanced lung cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The informed consent of the patient must be obtained before any research steps are carried out.
Confirmation of SCLC: Histological diagnosis or two imaging diagnoses must be made.
Late stage of SCLC, failure of second-line radiotherapy and chemotherapy or dangerous type of patients
Male or female subjects > 18 years old, < 75 years old
There are objective lesions that can be measured by CT.
The activity status of KPS was above 80 points.
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.
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.
The upper limit of normal serum creatinine < 1.5 times is
For pregnant women, the results of serum pregnancy test must be negative within 14 days before the start of treatment.
All male and female patients participating in this study must adopt reliable contraceptive measures during the trial and within two week.

Exclusion Criteria:

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

Sites / Locations

Tianjin Medical University Cancer Institute and HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Apatinib and S-1 group

Arm Description

Outcomes

Primary Outcome Measures

Objective Response Rate(ORR)

Secondary Outcome Measures

Disease Control Rate (DCR)

Full Information

NCT ID

NCT04128800

First Posted

October 15, 2019

Last Updated

October 15, 2019

Sponsor

Tianjin Medical University Cancer Institute and Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04128800

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Unknown status

Study Start Date

October 2019 (Anticipated)

Primary Completion Date

December 2020 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Small Cell Lung Cancer

Keywords

apatinib S-1, Advanced lung cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Apatinib and S-1 group

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Apatinib S-1

Other Intervention Name(s)

apatinib mesylate tablets

Intervention Description

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.

Primary Outcome Measure Information:

Title

Objective Response Rate(ORR)

Time Frame

one year

Secondary Outcome Measure Information:

Title

Disease Control Rate (DCR)

Time Frame

one year

Other Pre-specified Outcome Measures:

Title

Progression free survival (PFS)

Time Frame

one year

Title

Overall survival (OS)

Time Frame

one year

Title

Quality of life (QoL)

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The informed consent of the patient must be obtained before any research steps are carried out. Confirmation of SCLC: Histological diagnosis or two imaging diagnoses must be made. Late stage of SCLC, failure of second-line radiotherapy and chemotherapy or dangerous type of patients Male or female subjects > 18 years old, < 75 years old There are objective lesions that can be measured by CT. The activity status of KPS was above 80 points. 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. 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. The upper limit of normal serum creatinine < 1.5 times is For pregnant women, the results of serum pregnancy test must be negative within 14 days before the start of treatment. All male and female patients participating in this study must adopt reliable contraceptive measures during the trial and within two week. Exclusion Criteria: KPS < 60 points, or expected survival < 3 months. Severe cardiovascular diseases . Uncontrollable hypertension . History of human immunodeficiency virus (HIV) infection . Active clinical severe infections (Grade 2, NCI-CTCAE Version 3.0) . Epilepsy patients requiring medication (e.g. steroids or antiepileptic drugs) . History of allogeneic organ transplantation . Patients with signs of hemorrhage or history of disease. Patients undergoing renal dialysis. Chronic obstructive pulmonary emphysema . Gastrointestinal bleeding within 30 days before admission . Patients have a history of esophageal varices bleeding, and subsequently did not receive effective treatment or treatment to prevent recurrence of bleeding.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ning bo Liu, MD

Phone

15822117210

liuningbo@tjmuch.com

First Name & Middle Initial & Last Name or Official Title & Degree

Ping Wang, MD

Phone

18622221112

wangping99999@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ning bo Liu, MD

Organizational Affiliation

Tianjin Medical University Cancer Institute & Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tianjin Medical University Cancer Institute and Hospital

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ning bo Liu, MD

Phone

15822117210

liuningbo@tjmuch.com

First Name & Middle Initial & Last Name & Degree

Ping Wang, MD

Phone

18622221112

wangping99999@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

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

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