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Explorative study, which evaluates the effect of Camrelizumab combined with albumin-bound paclitaxel and platinum in neoadjuvant treatment of resectable non-small-cell lung carcinoma.
This is a multicenter, randomized, open parallel controlled trial to evaluate the efficacy and safety of camrelizumab combined with albumin-bound paclitaxel and platinum versus albumin-bound paclitaxel combined with platinum in resectable stage IIIA -IIIB NSCLC (IIIB is limited toT3N2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: Experimental Group | Experimental | Participants receive totally 3 cycles of camrelizumab combined with albumin-bound paclitaxel and Cisplatin/carboplatin/Nedaplatin treatment during preoperative period, every 3 weeks for up to 3 cycles. |
|
| B: Control group | Active Comparator | Participants receive totally 3 cycles of albumin-bound paclitaxel combined with Cisplatin/carboplatin/Nedaplatin treatment during preoperative period, every 3 weeks for up to 3 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| camrelizumab、albumin-bound paclitaxel and platinum | Drug | Experimental Group:camrelizumab、albumin-bound paclitaxel and platinum. Camrelizumab will be administered as a 30-minute IV infusion Q3W at a dose of 200mg on day1 of each cycle. Albumin-bound paclitaxel will be administered as a 30-minute IV infusion Q3W at a dose of 130 mg/m2 on day1 and day8 of each cycle. Platinum included Cisplatin/carboplatin/Nedaplatin |
| Measure | Description | Time Frame |
|---|---|---|
| pathological complete response (pCR) | no residual tumor cells in the surgically resected tumor specimen and all sampled regional lymph nodes after neoadjuvant treatment. | The day of the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| main pathology rate (MPR) | Major pathological response rate (MPR): defined as ≤ 10% of residual tumor cells in the surgically resected tumor specimen and sampled regional lymph nodes after neoadjuvant treatment. | The day of the surgery |
| Objective Response Rate (ORR) |
| Measure | Description | Time Frame |
|---|---|---|
| type of surgery、R0 Resection、Surgical approach、Duration from final treatment to surgery、Duration of surgery、Length of hospital stay and rate of peri- and post-operative complications | enumeration data:type of surgery、R0 Resection、Surgical approach measurement data:Duration from final treatment to surgery、Duration of surgery、Length of hospital stay. Peri- and post-operative complications reported up to 30 days after surgery. The Clavien-Dindo scale classifies peri- and post-operative complications into 5 grades.complications (within 30 days of surgery) in subjects treated with camrelizumab plus chemotherapy compared to those treated with chemotherapy alone. |
Inclusion Criteria:
Exclusion Criteria:The subject must be excluded from participating in the trial if the subject:
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| Name | Affiliation | Role |
|---|---|---|
| Jiang Tao, PhD | The Fourth Military Medical University Tangdu Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fourth Military Medical University Tangdu Hospital | Xi'an | Shaanxi | 710038 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37535377 | Derived | Lei J, Zhao J, Gong L, Ni Y, Zhou Y, Tian F, Liu H, Gu Z, Huang L, Lu Q, Wang X, Sun J, Yang E, Wang T, Zhong D, Wang J, Zhao Z, Liu Z, Wang C, Wang X, Lei G, Yan X, Jiang T. Neoadjuvant Camrelizumab Plus Platinum-Based Chemotherapy vs Chemotherapy Alone for Chinese Patients With Resectable Stage IIIA or IIIB (T3N2) Non-Small Cell Lung Cancer: The TD-FOREKNOW Randomized Clinical Trial. JAMA Oncol. 2023 Oct 1;9(10):1348-1355. doi: 10.1001/jamaoncol.2023.2751. |
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This is a multicenter, randomized, open-label, parallel controlled trial.
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|
| albumin-bound paclitaxel and platinum | Drug | Control group:albumin-bound paclitaxel and platinum. Albumin-bound paclitaxel will be administered as a 30-minute IV infusion Q3W at a dose of 130 mg/m2 on day1 and day8 of each cycle. Platinum included Cisplatin/carboplatin/Nedaplatin |
|
Objective response rate (ORR): defined as the proportion of patients whose tumor size shrinks to predefined values,which including cases of CR and PR. Objective tumor response will be assessed using RECIST 1.1. Subjects must have measurable tumor lesions at baseline, and the response evaluation criteria are classified as complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) according to RECIST 1.1. |
| pre-operation |
| Event-free Survival (EFS) | Event-free survival (EFS): defined as the time from the randomization to the first occurrence of disease progression or recurrence, or death (due to any cause). | Event-free survival (EFS): defined as the time from the randomization until the date of first documented progression or recurrence or date of death from any cause, whichever came first, assessed up to 100 months |
| Assess adverse events | Assess all adverse events according to the NCI Common Terminology Criteria for (NCI CTCAE) v5. | 90 days |
| within 30 days of surgery |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D010984 | Platinum |
| D000068196 | Albumin-Bound Paclitaxel |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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