Status:
UNKNOWN
Camrelizumab Combined With Albumin-bound Paclitaxel and Platinum in Neoadjuvant Treatment of Resectable NSCLC
Lead Sponsor:
Tang-Du Hospital
Conditions:
Non-small-cell Lung Cancer (NSCLC)
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
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 paclitaxe...
Eligibility Criteria
Inclusion
- Age :18 Years to 70 Years (Adult, Older Adult)
- ECOG physical score status of 0 or 1 points;
- expected survival time ≥ 12 weeks;
- Pathological diagnosis with StageIIIA-IIIB NSCLC;
- According to the eighth edition of the AJCC/UICC TNM staging system, patients was pathological diagnosed with Stage III-N2 clinically resectable NSCLC.
- Patients with at least one evaluable or measurable lesions as per RECIST version 1.1 （CT scan length and diameter of tumor lesion≥10mm，CT scan of lymph node lesion was short diameter≥15mm；）
- Patients were newly diagnosed with non-small cell lung cancer, without radiotherapy, chemotherapy, surgery or molecule-targeted treatment.
- Patients must have enough cardiopulmonary function for the expected pulmonary resections for lung cancer.
- The main organ function meets the following criteria:1) blood routine:a. ANC ≥ 1.5×109/L; b. PLT ≥ 100×109/L; c. HB ≥ 90 g/L; 2) Blood biochemistry:TBIL ≤ 1.5×ULN;ALT、AST≤ 2.5×ULN;sCr≤1.5×ULN; 3) Blood coagulation: INR≤1.5×ULN and APTT≤1.5×ULN，endogenous creatinine clearance rate≥50ml/min(Cockcroft-Gault formula);
- Pregnancy test (serum or urine) has to be performed for woman of childbearing age within 7 days before enrolment and the test result must be negative. They shall take appropriate methods for contraception during the study until the 3 months post the last administration of study drug. For men, (previous surgical sterilization accepted), shall agree to take appropriate methods of contraception during the study until the 3 months post the last administration of study drug;
- Patient has to voluntarily join the study and sign the Informed Consent Form for the study.
Exclusion
- The subject must be excluded from participating in the trial if the subject:
- Patients with brain metastasis
- Patients with autoimmune disease, or a history of autoimmune disease including but not limited to the following: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism which can be included after hormone replacement therapy; Subjects with childhood asthma have been completely alleviated and without any intervention or vitiligo in adulthood can be included.
- Subjects who need medical intervention with bronchodilators cannot be included.
- Subjects with congenital or acquired immunodeficiency such as HIV infection, active hepatitis B (HBV DNA ≥ 2000 IU/mL), hepatitis C (hepatitis C antibody is positive);
- Subjects with a condition requiring other immunosuppressive medications before 14 days of study drug administration firstly, not including inhaled corticosteroids or physiological doses of systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents).
- Has received a live vaccine within 4 weeks of planned start of study therapy.
- Other malignancies have been diagnosed within 3 years prior to the first use of the study drug; 8. Patients with a current or history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiologic pneumonia, drug-induced pneumonia and severe impairment of lung function.
- Patients with hypertension that is difficult to control (systolic blood pressure ≥140 mmHg and diastolic blood pressure ≥90 mmHg);
- patients with myocardial ischemia and myocardial infarction above class II (including QT interval prolongation, for man ≥ 450 ms, for woman ≥ 470 ms);
- Severe infection within 4 weeks before the first administration (such as intravenous drip of antibiotics, antifungal drugs or antiviral drugs), or fever of unknown origin (\> 38.5 ℃) within 4 weeks before the first administration.
- allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation.
- Pregnant or nursing women; 14. Patients with a history of hypersensitivity to any of the study drugs, similar drugs, or excipients.
- Participated in other clinical trials within 4 weeks; 16. Patients with the history of drug abused or alcohol.
- The investigator believes that there are any conditions that may damage the subject or result in the subject being unable to meet or perform the research request;
Key Trial Info
Start Date :
April 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2023
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT04338620
Start Date
April 7 2020
End Date
November 1 2023
Last Update
March 6 2023
Active Locations (1)
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1
The Fourth Military Medical University Tangdu Hospital
Xi'an, Shaanxi, China, 710038