Radiation Therapy Followed by Tislelizumab and Anlotinib Aeoadjuvant/Adjuvant Therapy for Stage II-IIIA NSCLC
NCT ID: NCT06379087
Last Updated: 2025-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
20 participants
INTERVENTIONAL
2024-05-01
2026-12-31
Brief Summary
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Detailed Description
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After completing all screening activities, eligible patients will enter the study and receive the following treatment and visits: First, receive 24 Gy (8 Gy\*3) of hypofractionated treatment on d1-3 after the start of the study, and then receive neoadjuvant therapy with tislelizumab combined with anlotinib within 1 week after radiotherapy. Each 3 weeks is a medication cycle, for a total of 2 cycles. Patients will undergo radical surgery after neoadjuvant treatment, and then receive tislelizumab and anlotinib adjuvant treatment after surgery. Each 3 weeks is a medication cycle, and it is maintained for 1 year. The 1-year event-free survival (EFS) rate, complete pathological response (pCR) and major pathological response (MPR) were evaluated to evaluate the safety of medical/surgical treatment for patients.
Neoadjuvant therapy regimen (2 cycles):
1. Receive 3-day hypofractionated treatment on Day 1, Day 2, and Day 3, with a total dose of 24Gy (8Gy\*3).
2. Within 1 week after radiotherapy, receive neoadjuvant tislelizumab (200 mg, intravenous drip, d1) combined with anlotinib (10 mg, oral, D1-14) . Each 3 weeks is a medication cycle.
Surgical protocol: The surgical approach was determined by the surgeon according to the patient's condition, including but not limited to thoracoscopic/open lobectomy/sleeve lobectomy/combined lobectomy/pneumonectomy. Lymph node dissection requires at least three stations of mediastinal lymph node dissection.
Adjuvant therapy regimen: tislelizumab (200 mg, intravenous drip, d1) combined with Anlotinib (10 mg, oral, D1-14). Each 3 weeks is a medication cycle, for 1 year.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single Arm
Neoadjuvant therapy regimen (2 cycles):
1. Receive 3-day hypofractionated treatment on Day 1, Day 2, and Day 3, with a total dose of 24Gy (8Gy\*3).
2. Within 1 week after radiotherapy, receive neoadjuvant tislelizumab (200 mg, intravenous drip, d1) combined with anlotinib (10 mg, oral, D1-14) . Each 3 weeks is a medication cycle.
Surgical protocol: The surgical approach was determined by the surgeon according to the patient's condition, including but not limited to thoracoscopic/open lobectomy/sleeve lobectomy/combined lobectomy/pneumonectomy. Lymph node dissection requires at least three stations of mediastinal lymph node dissection.
Adjuvant therapy regimen: tislelizumab (200 mg, intravenous drip, d1) combined with Anlotinib (10 mg, oral, D1-14). Each 3 weeks is a medication cycle, for 1 year.
Anlotinib Hydrochloride Capsule
Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor that inhibits both tumor angiogenesis and tumor cell proliferation by blocking VEGFR, FGFR, PDGFR, and c-Kit simultaneously.
Tislelizumab Injection
Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody.
Hypofractionated Radiotherapy
Hypofractionated Radiotherapy Extent of radiotherapy: Primary lesion in the lung. Radiotherapy technique: IGRT. Radiotherapy delivery equipment: linear accelerator or TOMO accelerator or CyberKnife.
Interventions
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Anlotinib Hydrochloride Capsule
Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor that inhibits both tumor angiogenesis and tumor cell proliferation by blocking VEGFR, FGFR, PDGFR, and c-Kit simultaneously.
Tislelizumab Injection
Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody.
Hypofractionated Radiotherapy
Hypofractionated Radiotherapy Extent of radiotherapy: Primary lesion in the lung. Radiotherapy technique: IGRT. Radiotherapy delivery equipment: linear accelerator or TOMO accelerator or CyberKnife.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* (2) Early stage II-IIIA NSCLC (AJCC 8th edition), NSCLC, confirmed in tissue (AJCC eighth edition);
* (3) All lesions are assessed to be eligible for surgical resection;
* (4) The primary tumor can be treated with hypofractionated radiotherapy after evaluation;
* (5) Epidermal growth factor receptor/anaplastic lymphoma kinase/ROS1 gene fusions mutation was negative in primary tumor or lymph node metastasis;
* (6) ECOG PS score: 0\~1;
* (7) Expected survival more than 1 year;
* (8) At least one measurable lesion (RECIST 1.1);
* (9) Females of childbearing potential should agree to use contraceptive measures (such as intrauterine device, contraceptives or condoms) during the study and within 3 months after the end of the study; have a negative serum or urine pregnancy test within 7 days before study enrollment and must be non-lactating subjects; and males should agree to use contraceptive measures during the study and within 3 months after the end of the study period;
* (10) Subjects voluntarily participate in this study, sign the informed consent form and had good compliance;
* (11) Subjects are suitable after MDT discussion.
Exclusion Criteria
* (1) The location of the primary tumor was assessed by the radiologist and considered unsuitable for hypofractionated therapy;
* (2) The pathological type is small cell lung cancer, or mixed tumor with small cell components;
* (3) A history of or concurrent with other malignancies;
* (4) Received any anti-tumor treatment before this study, including chemotherapy, radiotherapy, targeted therapy (including but not limited to monoclonal antibodies, small molecule tyrosine kinase inhibitors, etc.) and immunotherapy;
* (5) The Imaging (CT/MR/PET-CT) showed tumor invasion of great vessels or blurred boundary with blood vessels, or the presence of any pulmonary cavity or necrotic lesions;
* (6) Hemoptysis, active bleeding, ulcer, intestinal perforation, intestinal obstruction within 3 months before enrollment;
* (7) Previous interstitial lung disease, drug-induced interstitial disease or any clinical evidence of active interstitial lung disease; baseline CT scan found idiopathic pulmonary fibrosis;
* (8) According to the investigator's judgment, there are serious or uncontrollable systemic diseases (such as unstable or uncompensated respiratory, cardiac, hepatic or renal diseases) or any unstable systemic diseases (including active infection, grade III hypertension, unstable angina, congestive heart failure, liver and kidney or metabolic diseases);
* (9) Previous treatment with anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs acting on another co-inhibitory T cell receptor (e.g., CTLA-4, OX-40, CD137);
* (10) The presence of uncontrollable third space effusion, such as a large number of pleural effusion or ascites or pericardial effusion;
* (11) Urine routine showed urine protein ≥ + +, or 24h urine protein ≥ 1g or severe liver and kidney dysfunction;
* (12) Uncontrollable hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg);
* (13) Subjects requiring systemic treatment with corticosteroids (\> 10 mg/day prednisone or equivalent) or other immunosuppressive agents within 14 days before the first dose;
* (14) Hyperactive/venous thrombotic events occurred within 6 months, such as cerebrovascular accident (including cerebral hemorrhage, cerebral infarction, temporary ischemic attack, etc.);
* (15) Excessive surgery or significant trauma within 28 days before enrollment;
* (16) Pregnant or lactating women;
* (17) Subjects who are considered to be unsuitable for enrollment for other reasons according to the judgment of the investigators..
18 Years
75 Years
ALL
No
Sponsors
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Ji Yongling
OTHER
Responsible Party
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Ji Yongling
Physician
Principal Investigators
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YongLing Ji, PhD
Role: STUDY_DIRECTOR
Zhejiang Cancer Hospital
Locations
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Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Other Identifiers
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NEO-PIONEER
Identifier Type: -
Identifier Source: org_study_id
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