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| Name | Class |
|---|---|
| Guangdong Provincial People's Hospital | OTHER |
| Third Affiliated Hospital, Sun Yat-Sen University | OTHER |
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This prospective, single-arm, multicenter, phase II trial enrolled 40 patients who underwent surgery after three cycles of neoadjuvant therapy with camrelizumab, nab-paclitaxel, and carboplatin. The MPR is the primary endpoint, and the pCR, the complete resection rate, the objective response rate, the disease-free survival, adverse events, and quality of life are the secondary endpoints. The exploratory endpoints will be used to establish a multiomics artificial intelligence system for neoadjuvant therapy effect prediction and decision-making assistance based on radiomics, metabolism, genetic, and clinic-pathological characteristics and to explore drug resistance mechanisms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camrelizumab + Nab-paclitaxel + Carboplatin | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab + Nab-paclitaxel + Carboplatin | Drug | The patients will receive three cycles (one cycle is defined as every 21 days +/- 3 days) of neoadjuvant therapy with camrelizumab 200 mg, nab-paclitaxel 260 mg/m2, and carboplatin AUC 5. This will then be followed by surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Major pathologic response (MPR) Rate | MPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy. | After surgery (approximately 10 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the pathological complete response (pCR) | pCR rate is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy. | After surgery (approximately 10 weeks) |
| Evaluation of complete resection (R0) rate |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Herui Yao, PhD | Contact | 18218018525 | yaoherui@mail.sysu.edu.cn | |
| Yunfang Yu, MD | Contact | yuyf9@mail.sysu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-Sen Memorial Hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510120 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34992825 | Derived | Zhou H, Lin L, Qin T, Ren W, Tan Y, Yang Q, Xu H, Xie X, Chen Y, Liu S, Li X, Li Z, Hu H, Yu Y, Yao H. Neoadjuvant camrelizumab, nab-paclitaxel, and carboplatin in patients with stage IB-IIIA non-small cell lung cancer (NANE-LC): a study protocol of prospective, single-arm, multicenter, phase II study. J Thorac Dis. 2021 Nov;13(11):6468-6475. doi: 10.21037/jtd-21-1022. |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| C520255 | 130-nm albumin-bound paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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Proportion of patients with no residual resection margin under the microscope after tumor resection |
| After surgery (approximately 10 weeks) |
| Disease free survival (DFS) | From the date of surgery to any of the following events: disease progression, disease recurrence or death from any cause. | 36 months |
| Overall survival (OS) | From the date of participated in study to the date of death. | 36 months |
| Objective response rate(ORR) | The proportion of patients achieved complete or patial remission(Imageological) according to RECIST 1.1 prior to definitive surgery | approximately 9 weeks |
| Adverse events (AEs) | The number of participants experiencing an AE will be assessed.An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy can be determined | approximately 9 weeks |
| Serious adverse events (SAEs) | The number of participants experiencing an serious AE will be assessed | approximately 9 weeks |
| Qol Quality of Life | Quality of life asscesed by Quality of Life Questionnare-Core 30(EORTC QLQ-C30)of The European O-rganization for Reasearch and Functional Assessment of Cancer Therapy-Lung (FACT-L) | 36 months |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |