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

NCT04128800 | Unknown Phase 2

• 1 other identifier: AHEAD-HBH
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Small Cell Lung Cancer

Keywords

apatinib S-1; Advanced lung cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate(ORR)

  one year

Secondary Outcomes (1)

• Disease Control Rate (DCR)

  one year

Other Outcomes (3)

• Progression free survival (PFS)

  one year

• Overall survival (OS)

  one year

• Quality of life (QoL)

  one year

Study Arms (1)

Apatinib and S-1 group

EXPERIMENTAL

Drug: Apatinib S-1

Interventions

Apatinib S-1 DRUG

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.

Also known as: apatinib mesylate tablets

Apatinib and S-1 group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

apatinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ning bo Liu, MD

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ning bo Liu, MD

CONTACT

15822117210; liuningbo@tjmuch.com

Ping Wang, MD

CONTACT

18622221112; wangping99999@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2019
• First Posted: October 16, 2019
• Study Start: October 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: October 16, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

CN (1)