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Concurrent Chemoradiotherapy Combination With Anlotinib for Limited-stage Small Cell Lung Cancer | Clinical Trials | Clareo Health

UNKNOWNPHASE1

Concurrent Chemoradiotherapy Combination With Anlotinib for Limited-stage Small Cell Lung Cancer

An Exploratory Clinical Study to Investigate Concurrent Chemoradiotherapy Combination With Anlotinib for Limited-stage Small Cell Lung Cancer

NCT04882033•Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the tolerability and toxicity of different dose of anlotinib combination with concurrent chemoradiotherapy in the treatment of limited-stage SCLC patients.

Detailed Description

Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR1、VEGFR2、VEGFR3、FGFR1/2/3、PDGFRa/β c-Kit and MET. The purpose of this study is to determine the maximum tolerated dose of anlotinib when combination with concurrent chemoradiotherapy. From low dose group up to high dose group, each one had 3 patients at least. Primary group received anlotinib 8mg. The dose of anlotinib would increase gradually until MTD.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients voluntarily participate in this study, signed informed consent.
•2. Patients aged between 18 -75 years; According to the eighth edition of AJCC and the standard of the VALG two-stage staging method, the patient is confirmed by histology or cytology as limited-stage SCLC (stage I-III, any T, any N, M0) and cannot be operated on.
•3. Patients with ECOG PS Scoring: 0\~1 point
•4. Patients with concurrent chemoradiotherapy must comply with relevant regulations.
•5. PCI is given according to the judgment of the investigator.
•6. Patients with normal organ function, the following criteria are met: (1) blood routine examination criteria (without blood transfusion in 14 days) : a) hemoglobin (HB) ≥90g/L; b) absolute neutrophil count (ANC) ≥1.5×10e9/L; c) platelet (PLT) ≥80×10e9/L; (2) biochemical tests meet the following criteria: a) total bilirubin (TBIL) ≤1.5 times of upper limit of normal (ULN); b) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 ULN, if liver metastasis occurred, ALT and AST ≤5 ULN; c) serum creatinine (Cr) ≤1.5 ULN or creatinine clearance (CCr) ≥60mL/min.
•7. For women of child-bearing age, the pregnancy test results (serum or urine) within 1 week before enrolment must be negative. They will take appropriate methods for contraception during the study until the 6 months post the last administration of study drug. For men (previous surgical sterilization accepted), will take appropriate methods for contraception during the study until the 6 months post the last administration of study drug.

Exclusion Criteria

•1. Small cell and non-small cell mixed lung cancer
•2. Extensive stage small cell lung cancer
•3. Central lung tumors that imaging shows tumor lesions invade local large blood vessels; or with significant pulmonary cavum or necrotizing
•4. Less than 4 weeks from the last clinical trial or participating in other clinical studies.
•5. History:
•1\) Brain metastasis or spinal cord compression 2) Other active malignancies that require simultaneous treatment. 3) History of immunodeficiency, including HIV-positive or other acquired, congenital immunodeficiency disease, or history of organ transplantation.
•4\) History of mental drug abuse and cannot be cured or have mental disorders 6. Patients with any severe and/or uncontrolled disease, including:
•1. blood pressure control is not ideal (systolic blood pressure ≥ 150 mmHg, diastolic blood pressure ≥ 100 mmHg);
•2. Significant cardiac disease as defined as: grade I or greater myocardial infarction, unstable arrhythmia (including corrected QT interval (QTc ) period between male or greater 450 ms, female or greater 470 ms); New York Heart Association (NYHA) grade II or greater heart dysfunction , or Echocardiography reveal left ventricular ejection fraction (LVEF) less than 50%
•3. Decompensated diabetes or other remedies for high-dose glucocorticoid therapy.
+7 more criteria

Locations (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Key Dates

Start Date

May 7, 2021

Primary Completion Date

July 1, 2021

Completion Date

July 1, 2023

Last Updated

May 11, 2021

Enrollment

ESTIMATED participants

Conditions

Small Cell Lung Cancer Limited Stage

Interventions

Concurrent chemoradiotherapy plus anlotinib

DRUG

Contacts

Xiyan Nan, Doctor

CONTACT

+86 18811796429 18811796429@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 11, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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