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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04128800
Recruitment Status : Recruiting
First Posted : October 16, 2019
Last Update Posted : October 16, 2019
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital

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

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Drug: Apatinib S-1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Apatinib and S-1 group Drug: Apatinib S-1
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 Name: apatinib mesylate tablets

Primary Outcome Measures :
  1. Objective Response Rate(ORR) [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Disease Control Rate (DCR) [ Time Frame: one year ]

Other Outcome Measures:
  1. Progression free survival (PFS) [ Time Frame: one year ]
  2. Overall survival (OS) [ Time Frame: one year ]
  3. Quality of life (QoL) [ Time Frame: one year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04128800

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Contact: Ning bo Liu, MD 15822117210
Contact: Ping Wang, MD 18622221112

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China, Tianjin
Tianjin Medical University Cancer Institute and Hospital Recruiting
Tianjin, Tianjin, China, 300060
Contact: Ning bo Liu, MD    15822117210   
Contact: Ping Wang, MD    18622221112   
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
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Principal Investigator: Ning bo Liu, MD Tianjin Medical University Cancer Institute & Hospital

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Responsible Party: Tianjin Medical University Cancer Institute and Hospital Identifier: NCT04128800     History of Changes
Other Study ID Numbers: AHEAD-HBH
First Posted: October 16, 2019    Key Record Dates
Last Update Posted: October 16, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tianjin Medical University Cancer Institute and Hospital:
apatinib S-1
Advanced lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action