Radiotherapy Plus Anlotinib in LA-NSCLC Intolerable to cCRT
NCT ID: NCT07037680
Last Updated: 2025-07-09
Study Results
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Basic Information
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RECRUITING
PHASE2
44 participants
INTERVENTIONAL
2024-01-01
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Radiotherapy plus Anlotinib
Radiotherapy plus anlotinib in LA-NSCLC intolerable to cCRT
Anlotinib
For patients treated with conventional Intensity-Modulated Radiation Therapy (IMRT), the median prescribed dose was 60 Gy/30 fractions (range: 50.0-70.0 Gy, in 25-35 fractions) (median BED10 72 Gy, range: 60-84 Gy) to the planning target volume (PTV). As for patients with IMRT-based simultaneously integrated boost (SIB), the median prescribed dose was 59.92 Gy/28 fractions (range: 50.0-70.0 Gy, in 25-33 fractions) (median BED10 72.74 Gy, range: 60-84 Gy) to the planning gross tumor volume (PGTV), and 50.4 Gy/28 fractions (range: 45-59.4 Gy, in 25-33 fractions) (median BED10 59.47 Gy, range: 53.1-70.1 Gy) to the PTV. It should be noted that the PTV in the SIB group contains the PGTV.
Anlotinib was administered orally concurrently with the first day of radiotherapy, at a dose of 12 mg for a maximum of three cycles. Each cycle was defined as 2 weeks on-treatment followed by 1 week off-treatment. If intolerance occurs, the dose may be reduced to 8-10 mg/day or stopped.
Interventions
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Anlotinib
For patients treated with conventional Intensity-Modulated Radiation Therapy (IMRT), the median prescribed dose was 60 Gy/30 fractions (range: 50.0-70.0 Gy, in 25-35 fractions) (median BED10 72 Gy, range: 60-84 Gy) to the planning target volume (PTV). As for patients with IMRT-based simultaneously integrated boost (SIB), the median prescribed dose was 59.92 Gy/28 fractions (range: 50.0-70.0 Gy, in 25-33 fractions) (median BED10 72.74 Gy, range: 60-84 Gy) to the planning gross tumor volume (PGTV), and 50.4 Gy/28 fractions (range: 45-59.4 Gy, in 25-33 fractions) (median BED10 59.47 Gy, range: 53.1-70.1 Gy) to the PTV. It should be noted that the PTV in the SIB group contains the PGTV.
Anlotinib was administered orally concurrently with the first day of radiotherapy, at a dose of 12 mg for a maximum of three cycles. Each cycle was defined as 2 weeks on-treatment followed by 1 week off-treatment. If intolerance occurs, the dose may be reduced to 8-10 mg/day or stopped.
Eligibility Criteria
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Inclusion Criteria
2. Peripheral tumor, or central lung cancer with non-squamous tissue or a mixed tissue with less than 50% squamous carcinoma;
3. Eastern cooperative oncology group (ECOG) score ≤2 was required;
4. Received systemic chemotherapy or combined chemotherapy and immumitherapy for ≥ 4 weeks without progression;
5. .No cavity inside the tumor, and located ≥ 1 cm of the main pulmonary artery trunk;
6. No symptoms of hemoptysis;
7. Adequate hepatic and renal functions with a negative urine protein;
8. Expected survival of more than 6 months.
Exclusion Criteria
2. previous malignancy within five years;
3. thoracic radiotherapy history, hemoptysis, myocardial infarction or cerebrovascular accident within three months;
4. uncontrolled or active pulmonary inflammation;
5. participated in other clinical trials;
6. Pregnant women.
18 Years
ALL
No
Sponsors
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JIANYANG WANG
OTHER
Responsible Party
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JIANYANG WANG
Principal Investigator
Principal Investigators
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jianyang wang
Role: PRINCIPAL_INVESTIGATOR
National Cancer Center
Locations
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Department of Radiation Oncology,Cancer Institute and Hospital,Chinese
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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NCC2827
Identifier Type: -
Identifier Source: org_study_id
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