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Current studies confirmed that the immune perioperative treatment with combination chemotherapy curative effect and safety of resectable NSCLC, but its short-term curative effect and long-term survival benefit remains to be further improved to explore the new way of immune combination therapy.
Experimental study showed that the inhibition of PCSK9 could significantly increase in tumor cells of the immune response in mice, inhibit the PCSK9 enhanced anti-tumor immune response of mice can be further coordinate with immune checkpoint therapy, forming a lasting anti-tumor immune effect.
There are no reports on the peri-operative treatment of immune combined with chemotherapy and PCSK-9 inhibitors in patients with resectable NSCLC.
Based on the above, the aim of this study is to explore the efficacy and safety of Adebrelimab combined with recaticimab and chemotherapy in the perioperative treatment of patients with resectable NSCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adebrelimab plus albumin-bound paclitaxel, carboplatin and recaticimab | Experimental | Participants will receive Adebrelimab 1200mg IV on Day 1 of a 21-Day cycle plus albumin-bound paclitaxel 260 mg/m2, IV, divided by D1,8 of a 21-Day cycle plus Carboplatin AUC 5mg/mL/min, IV, and recaticimab 150 mg, SC on the Day 1 of a 21-Day cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adebrelimab plus albumin-bound paclitaxel, carboplatin and recaticimab | Drug | Adebrelimab (1200 mg,IV, D1, Q3W) + albumin-bound paclitaxel (260 mg/m2, IV, divided by D1,8,Q3W) + carboplatin (AUC 5mg/mL/min, IV, D1,Q3W) + recaticimab (150 mg, SC, D1,Q3W) 21-day cycle |
| Measure | Description | Time Frame |
|---|---|---|
| pCR | Pathological complete response; | 1.5 year |
| Measure | Description | Time Frame |
|---|---|---|
| MPR | major pathologic response | through study completion, an average of 2 year |
| ORR | Objective response rate | through study completion, an average of 2 year |
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Inclusion Criteria:
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinghui Wang | Contact | 13683128239 | jinghuiwang2006@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jinghui Wang | Director of Research Laboratory, Beijing Chest Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chest Hospital | Recruiting | Beijing | Beijing Municipality | 101125 | China |
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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 |
|---|---|
| D000068196 | Albumin-Bound Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 |
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| EFS | Event free survival | through study completion, an average of 2 year |
| DFS | Disease free survival | through study completion, an average of 2 year |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D056831 | Coordination Complexes |