Adjuvant Chemotherapy Combined With Camrelizumab for ⅡA -ⅢA NSCLC Patients

Официальное название

Efficacy and Safety of Postoperative Adjuvant Chemotherapy Combined With Camrelizumab for Patients With ⅡA -ⅢA Non-small Cell Lung Cancer：a Phase II , Single-arm Clinical Study

Обзор

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.

Вмешательства

• Препарат Camrelizumab
  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.

Первичные конечные точки

• Two-years disease free survival (2y-DFS) [Срок оценки: Up to approximately 2 years]

Вторичные конечные точки (8)

• Three-years disease free survival (3y-DFS) [Срок оценки: Up to approximately 3 years]
• Five-years disease free survival (5y-DFS) [Срок оценки: Up to approximately 5 years]
• Disease free survival (DFS） [Срок оценки: Up to approximately 2 years]
• Overall survival (OS) [Срок оценки: Up to approximately 5 years]
• Two-years overall survival（2y-OS) [Срок оценки: Up to approximately 2 years]
• Three-years overall survival（3y-OS) [Срок оценки: Up to approximately 3 years]
• Five-years overall survival（5y-OS) [Срок оценки: Up to approximately 5 years]
• Treatment-related adverse events（TRAE） [Срок оценки: Up to approximately 1 year]

Критерии участия

Критерии включения

• 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:

• Absolute neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L, hemoglobin ≥ 9g/dL;
• Total bilirubin ≤ 1.5 ULN; AST and ALT ≤ 2.5 ULN;
• Serum creatinine ≤ 1.25 ULN, or serum creatinine clearance ≥ 60ml/min;
• 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.

Критерии исключения

• Known or suspected to be allergic to the drug or any component of the drug related to the test;
• Patients who can receive targeted treatment;
• Other malignant tumors in five years before enrollment, excluding the cured cervical carcinoma in situ, the cured skin basal cell carcinoma, and other types of tumors that were cured only after surgical treatment;
• Myocardial infarction, unstable angina pectoris and grade II congestive heart failure in six months before enrollment; New angina pectoris occurred within 3 months; Ventricular arrhythmia requiring medication;
• Uncontrolled hypertension after treatment with antihypertensive drugs, i.e. systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥ 90mmHg;
• History of HIV infection, active period of HCV infection, active period of HBV infection (HBV-DNA>1000 copies/ml);
• The researcher judged that there was a risk of bleeding;
• Active severe clinical infection (≥ grade 3 CTCAE V5.0);
• Epilepsy patients who need medication;
• Allogeneic organ transplantation;
• Patients who need kidney dialysis;
• Thrombotic or embolic venous or arterial events occurred within six months before enrollment;
• Serious uncured wounds, ulcers or fractures;
• Interstitial pneumonia;
• Any malabsorption disease;
• Any disease that is unstable or may endanger the patient's safety;
• Drug abuse, medical, psychological or social diseases;
• Participate in other clinical studies within 3 months before enrollment;
• During pregnancy or lactation;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Nanfang Hospital, Southern Medical University — Guandong

Идентификаторы

NCT: NCT05825443 · NFEC-2023-031

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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