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primary purpose:Observe the pathological complete response rate (PCR) of postoperative tumor tissue resection and evaluate the safety of the treatment process.
primary purpose:Observe the pathological complete response rate (PCR) of postoperative tumor tissue resection and evaluate the safety of the treatment process.
Description of the study design This is a single-center, prospective, open-label, single-arm clinical study to preliminarily explore the single-arm clinical study administration and drug management of Sintilimab, anlotinib combined with neoadjuvant chemotherapy in stage IIA-IIIB NSCLC
Dosing regimen Sintilimab (200mg fixed dose) iv, d1, q3w + anlotinib 10mg, po, qd1-14, q3w, was evaluated after 3 cycles of chemotherapy and stopped for 3 weeks (21 days) after surgery for 4-6 weeks (21-42 days) after the last dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| neoadjuvant therapy | Experimental | Sintilimab (200mg fixed dose) iv, d1, q3w,anlotinib 10mg, po, qd1-14, q3w combine with Chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoadjuvant therapy 1 | Drug | Dosing regimen Sintilimab (200mg fixed dose) iv, d1, q3w + anlotinib 10mg, po, qd1-14, q3w, was evaluated after 3 cycles of chemotherapy and stopped for 3 weeks (21 days) after surgery for 4-6 weeks (21-42 days) after the last dose. |
| Measure | Description | Time Frame |
|---|---|---|
| pathological complete response (PCR) | pathological complete response (PCR) | up to 4 months |
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Inclusion Criteria:
Exclusion Criteria:
1 . Presof locally advanced unresectable or metastatic disease;
2.. peripheral neuropathy;
3.Active, known or suspected autoimmune diseases, type I diabetes, hypothyroidism that requires only hormone replacement therapy, skin diseases that do not require systemic treatment (such as vitiligo, psoriasis or alopecia), or diseases not expected to recur without external stimulus factors can be selected;
4. Systemic treatment with corticosteroids (an equivalent dose of> 10 mg prednisone per day) or other immunosuppressive drugs within 14 days before randomization.Inhalor topical steroids are permitted without active autoimmune disease.
5.Active Hepatitis B / hepatitis C infection and known HIV;
6.Patients who have previously received chemotherapy or any other anti-tumor therapy;
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tangdu Hospital, the Air Force Military University | Xi'an | 710038 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39465257 | Derived | Duan H, Shao C, Luo Z, Wang T, Tong L, Liu H, Yao X, Lei J, Zhao J, Gao Y, Jiang T, Yan X. Perioperative sintilimab and neoadjuvant anlotinib plus chemotherapy for resectable non-small-cell lung cancer: a multicentre, open-label, single-arm, phase 2 trial (TD-NeoFOUR trial). Signal Transduct Target Ther. 2024 Oct 28;9(1):296. doi: 10.1038/s41392-024-01992-0. |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000625192 | anlotinib |
| D004358 | Drug Therapy |
| C000632826 | sintilimab |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Sintilimab (200mg fixed dose) iv, d1, q3w + anlotinib 10mg, po, qd1-14, q3w, was evaluated after 3 cycles of chemotherapy and stopped for 3 weeks (21 days) after surgery for 4-6 weeks (21-42 days) after the last dose.
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|
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |