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To evaluate the safety and effect of neoadjuvant chemotherapy and immunotherapy combined with probiotics for early resectable NSCLC patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | 3 cycles of nivolumab+Paclitaxel (albumin-bound type)+ Carboplatin AUC5 (21 days/cycle); as well as BiFico (oral taking, 4 capsules/time, 2 times per day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nivolumab 4.5mg/kg+Paclitaxel (albumin-bound type) 260mg / m2+ Carboplatin AUC5 | Drug | 3 cycles of nivolumab+Paclitaxel (albumin-bound type)+ Carboplatin AUC5 (21 days/cycle); as well as BiFico (oral taking, 4 capsules/time, 2 times per day) |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete response | The percentage of participants with 0% residual viable tumor cells in the primary tumor and sampled lymph nodes after neoadjuvant therapy, as assessed by a blinded independent pathological review. | Within 3 days after the operation |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | The percentage of participants who achieved complete response or partial response after 3 cycles of neoadjuvant therapy according to the RECIST 1.1 criteria. | 28 days after the completion of three cycles of neoadjuvant therapy and before the operation |
| Major Pathologic Response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yang Gao, Doctor | Xiangya Hospital of Central South University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Hospital of Central South University | Changsha | Hunan | 410008 | China |
all IPD that underlie results in a publication
IPD will be shared when the clinical trail is finished
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|
The percentage of participants with no more than 10% residual viable tumor cells in the primary tumor and sampled lymph nodes after neoadjuvant therapy, as assessed by a blinded independent pathological review. |
| Within 3 days after the operation |
| Disease free survival | The time (month) from the completion of lung cancer radical surgery to the recurrence or metastasis of the disease. | 1 year, 3 years and 5 years after the operation |
| Recurrence rate | The percentage of participants who have recurrence or metastasis of lung cancer at certain time points after radical surgery. | 1 year, 3 years and 5 years after the operation |
| Overall survival | The time (month) from the completion of lung cancer radical surgery to all-cause death. | 1 year, 3 years and 5 years after the operation |
| Adverse effects | The number of participants with treatment-related adverse events as assessed by CTCAE v5.0. | Treatment-related adverse events were assessed between the first neoadjuvant dose and 30 days after the last dose of neoadjuvant study treatment. |
| Surgical complications (intra-operative and peri-operative) | The number of participants with surgery-related adverse events that occur during or after a surgical procedure. | 90 days after the first medication or 30 days after the operation, whichever is later |
| R0 surgical events | The number of participants who have lung cancer completely resected. It is defined as the removal of negative margins, encompassing bronchial, arterial, venous peribronchial, and surrounding tissues near the tumor. In addition, at least 6 groups of lymph nodes must be removed, including at least 3 groups of intrapulmonary lymph nodes and 3 groups of mediastinal lymph nodes (station 7 lymph node must be included). The resected lymph nodes should be negative upon microscopic examination. | 28 days after the completion of three cycles of neoadjuvant therapy |
| Clinical TNM downstaging | The number of participants who achieve a decrease in the clinical TNM stage of lung cancer following neoadjuvant therapy before surgery. | 28 days after the completion of three cycles of neoadjuvant therapy and before the operation |
| 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 |
|---|---|
| D000077594 | Nivolumab |
| D017239 | Paclitaxel |
| D020086 | Short Interspersed Nucleotide Elements |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D018626 | Retroelements |
| D020071 | Interspersed Repetitive Sequences |
| D012091 | Repetitive Sequences, Nucleic Acid |
| D001483 | Base Sequence |
| D015394 | Molecular Structure |
| D001669 | Biochemical Phenomena |
| D055598 | Chemical Phenomena |
| D040342 | Genetic Structures |
| D055614 | Genetic Phenomena |
| D040481 | Genome Components |
| D016678 | Genome |
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