- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04882033
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Xiyan Nan, Doctor
- Phone Number: +86 18811796429
- Email: 18811796429@163.com
Study Locations
-
-
Tianjin
-
Tianjin, Tianjin, China, 300060
- Recruiting
- Tianjin Medical University Cancer Institute and Hospital
-
Contact:
- Dingzhi Huang, M.D.
- Phone Number: +86-22-23340123-1031
- Email: dingzhih72@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients voluntarily participate in this study, signed informed consent.
- 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.
- Patients with ECOG PS Scoring: 0~1 point
- Patients with concurrent chemoradiotherapy must comply with relevant regulations.
- PCI is given according to the judgment of the investigator.
- 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.
- 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:
- Small cell and non-small cell mixed lung cancer
- Extensive stage small cell lung cancer
- Central lung tumors that imaging shows tumor lesions invade local large blood vessels; or with significant pulmonary cavum or necrotizing
- Less than 4 weeks from the last clinical trial or participating in other clinical studies.
- 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:
- blood pressure control is not ideal (systolic blood pressure ≥ 150 mmHg, diastolic blood pressure ≥ 100 mmHg);
- 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%
- Decompensated diabetes or other remedies for high-dose glucocorticoid therapy.
- Exacerbation of chronic obstructive pulmonary disease (COPD) or other serious respiratory diseases that require hospitalization
- Active or uncontrollable serious infection (≥CTC AE Level 2 infection);
- Uncontrolled pleural effusion, pericardial effusion and abdominal effusion requiring repeated drainage.
- Urine routine test protein≥++, and confirmed 24 hours urine protein>1.0 g; 7. Imaging shows that the tumor has been violated around important vascular or the researchers determine the tumor is likely to invade important blood vessels caused by fatal bleeding during the follow-up.
8. Patients who received a major surgical treatment or severe trauma, the effects of surgery or trauma have been eliminated in less than 2 weeks before being enrolled 9. Patients with clinically significant hemoptysis occurred within 3 months prior to enrollment (greater than 1/2 teaspoon of bright red blood). History of clinically relevant major bleeding event (e.g. gastrointestinal hemorrhage, hemorrhagic acne, bleeding gastric ulcer, occult blood test ≥ ++, or vasculitis, etc.) 10. Patients who have arterial/venous thromboembolism events within 6 months before being enrolled, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.
11. Coagulation disfunction(INR>1.5 or PT>upper limit of normal(ULN)+4s or activated partial thromboplastin time (APTT) >1.5 upper limit of normal (ULN)), hemorrhagic tendency or receiving the therapy of thrombolysis or anticoagulation.
12. At the discretion of the investigator, the patient may have other factors that may cause the study to be terminated midway.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Concurrent chemoradiotherapy plus anlotinib
Concurrent chemoradiotherapy plus anlotinib for 4-6 cycles This study will include a sequential evaluation of 3 subjects per dose group.
Low-dose groups: anlotinib 8mg per day with concurrent chemoradiotherapy.
Middle-dose groups: anlotinib 10mg per day with concurrent chemoradiotherapy.
High-dose groups: anlotinib 12mg per day with concurrent chemoradiotherapy.
|
Anlotinib: for cycle 1-6. P.O; QD; from days 1 to 14 in a 21-day cycle. 8mg in low-dose groups (3 subjects). 10mg in middle-dose groups (3 subjects). 12mg in high-dose groups (3 subjects). Chemotherapy: For cycle 1/4/5/6. Etoposide 100mg/m2, d1-3, q3w; Cisplatin 25mg/m2 d1-3, q3w. For cycle 2/3. Etoposide 50mg/m2, d1-3, q4w; Cisplatin 25mg/m2 d1-3, q4w. Radiotherapy: For cycle 2/3.Thoracic radiotherapy dose will be 2.0Gy per day, given 5 days a week, to cumulative dose of 60~66Gy. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Tolerance Dose (MTD) is the dose of treatment in the cohort where there are 2 cases of DLT reported.
Time Frame: From enrollment to completion of study. Estimated about 18months
|
Dose Limiting Toxicity (DLT) is referred to grade 3 non-hematological toxicity or grade 4 hematological toxicity according to NCI CTCAE 4.03 criteria
|
From enrollment to completion of study. Estimated about 18months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
OS(Overall Survival)
Time Frame: From enrollment until death (up to 24 months)
|
OS was defined as time from date of enrollment to date of death due to any cause.
|
From enrollment until death (up to 24 months)
|
PFS(Progress free survival)
Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
|
The PFS time is defined as time from enrollment to locoregional or systemic
|
each 42 days up to intolerance the toxicity or PD (up to 24 months)
|
ORR(Objective Response Rate)
Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
|
Objective Response Rate (ORR) is defined as participants who had complete response (CR) or partial response(PR) divided by the total number of patients.
|
each 42 days up to intolerance the toxicity or PD (up to 24 months)
|
DCR(Disease Control Rate)
Time Frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
|
Disease Control Rate (DCR) defined as the percentage of participants with Disease Control best overall response (complete response, partial response or stable disease).
|
each 42 days up to intolerance the toxicity or PD (up to 24 months)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALTER-L039
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
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
Studies a U.S. FDA-regulated device product
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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