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| Name | Class |
|---|---|
| Jiangsu Hengrui Pharmaceutical Co., Ltd. | INDUSTRY |
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Postoperative adjuvant chemotherapy followed by immunotherapy for non-small cell lung cancer has become a new treatment recommendation, but there are still many clinical problems to be solved in postoperative adjuvant immunotherapy. This study aims to explore the efficacy and safety of adjuvant chemotherapy combined with immunotherapy in patients with stage IIA-IIIA non-small cell lung cancer after surgery. Patients who meet the protocol and sign the informed consent form received 4 cycles of chemotherapy combined with camrelizumab, followed by maintenance with camrelizumab until one year or the disease progressed or unacceptable toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Patients who meet the protocol and sign the informed consent form received 4 cycles of chemotherapy combined with camrelizumab, followed by maintenance with camrelizumab until one year or the disease progressed or unacceptable toxicity. The chemotherapy regimen is decided by the researcher. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | Patients received four 21-day cycles of chemotherapy (decided by the researcher) combined with camrelizumab (200 mg in day 1), followed by maintenance with camrelizumab (200 mg in day 1, q3w), until one year or the disease progressed or unacceptable toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| Two-years disease free survival (2y-DFS) | DFS, defined as the time from first dose of Camrelizumab to the first occurrence of disease recurrence as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first. According to the K-M curve, the proportion of disease-free progression in 2 years. | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Three-years disease free survival (3y-DFS) | According to the K-M curve, the proportion of disease-free progression in 3 years | Up to approximately 3 years |
| Five-years disease free survival (5y-DFS) |
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Inclusion Criteria:
Sign the informed consent form before starting the study;
For patients with non-small cell lung cancer who have undergone surgical resection, the TNM stage after surgery is IIA-IIIA;
Patients cannot receive targeted adjuvant therapy;
18-80 years old;
The patient can recover within 3-8 weeks after the operation, and receive postoperative adjuvant treatment;
The ECOG PS score is 0 or 1;
Have not received any chemotherapy for non-small cell lung cancer before enrollment;
Within 7 days before enrollment, the laboratory inspection must meet all the following requirements:
Female patients must meet: menopause or have undergone surgical sterilization. Women with fertility must take effective contraceptive measures. Do not breastfeed.
Male patients must agree to use appropriate contraceptive measures.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Di Lu | Contact | 020-62787240 | david_lu1989@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital, Southern Medical University | Recruiting | Guandong | Guangdong | 510515 | 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 |
|---|---|
| C000631724 | camrelizumab |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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Four cycles of chemotherapy combine with camrelizumab, followed by maintenance with camrelizumab until one year or the disease progressed or unacceptable toxicity
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|
According to the K-M curve, the proportion of disease-free progression in 5 years
| Up to approximately 5 years |
| Disease free survival (DFS) | DFS, defined as the time from first dose of Camrelizumab to the first occurrence of disease recurrence as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first. | Up to approximately 2 years |
| Overall survival (OS) | Defined as the time from randomization to death from any cause. | Up to approximately 5 years |
| Two-years overall survival(2y-OS) | According to the K-M curve, the proportion of OS in 2 years | Up to approximately 2 years |
| Three-years overall survival(3y-OS) | According to the K-M curve, the proportion of OS in 3 years | Up to approximately 3 years |
| Five-years overall survival(5y-OS) | According to the K-M curve, the proportion of OS in 5 years | Up to approximately 5 years |
| Treatment-related adverse events(TRAE) | The incidence of TRAE and the incidence of level 3-4 TRAE according to CTCAE v5.0 | Up to approximately 1 year |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D056831 |
| Coordination Complexes |
| D009930 | Organic Chemicals |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |