Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a prospective single-center, open-label, phase II study evaluating the efficacy of sintilimab plus anlotinib as a neoadjuvant regimen in the treatment of IB-IIIB resectable non-small cell lung cancer.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sintilimab | Drug | 200mg, every 3 weeks, 3 cycles, in the neoadjuvant setting, and adjuvant 200mg,every 3 weeks no more than one year |
|
| Measure | Description | Time Frame |
|---|---|---|
| major pathological response (MPR) | Viable tumor cells are no more than 10% in the resected specimen | 10 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| pathological complete response (pCR) | Viable tumor cells are not found in the resected specimen | 10 days postoperatively |
| treatment-related adverse events (TRAEs) | TRAEs including immune-related adverse reaction are documented and graded based on the US National Cancer Institute's Common Terminology Criteria for Adverse Events 5.0 criteria. |
| Measure | Description | Time Frame |
|---|---|---|
| minimal residual disease (MRD) | MRD is evaluated by testing circulating tumor DNA (ctDNA) in peripheral blood sample using next-generation sequencing(NGS) method. Each participant will undergo a minium of 3 tests for MRD. | 5 years |
Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria as follows:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fajiu Wang, PhD | Contact | +86-574-83870605 | wfjwyt@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Guofang Zhao, MD | Ningbo No.2 Hospital | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000632826 | sintilimab |
| C000625192 | anlotinib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Anlotinib | Drug | 8mg, orally, D1-14, every 3 weeks, 2 cycles in only neoadjuvant setting |
|
| 90 days after the last dose of study drugs |
| disease-free survival (DFS) | DFS is defined as the duration between the date of surgery and the date on which tumor recurrence is confirmed | 5 years |
| rate of operative complications | The rate of surgical complications (such as bleeding, bronchopleural fistula,ect) are recorded and graded according to Clavien-Dindo criteria | 30 days postoperatively |
| overall survival(OS) | OS is defined as the duration between the date of surgery and the date of all-cause death | 5 years |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |