Phase
Condition
Non-small Cell Lung Cancer
Treatment
Anlotinib
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The subjects voluntarily joined the study, signed the informed consent, and thecompliance was good;
≥18 years old (calculated by the date of signing the informed consent); Both men andwomen; ECOG score 0~1; Expected survival ≥3 months;
Patients with stage IIA-IIIA NSCLC who had previously received PD-1/PD-L1 inhibitorscombined with chemotherapy neoadjuvant therapy and underwent R0 resection forcurative purposes before surgery (note: the disease was presented in the AmericanJoint Committee on Cancer (AJCC)/Union International Against Cancer (UICC) 8thedition of lung cancer TNM staging);
For patients who did not achieve pathological complete response after PD-1/PD-L1inhibitor combined with chemotherapy neoadjuvant treatment, and the time between thefirst trial medication after surgery was required to be 4-12 weeks;
The main organs function well and meet the standards;
Women of reproductive age should agree that effective contraception must be usedduring the study period and for 6 months after the end of the study, and that serumor urine pregnancy tests are negative within 7 days prior to study enrollment; Menshould agree that effective birth control must be used during the study period andfor 6 months after the end of the study period.
Exclusion
Exclusion Criteria:
Have had or are currently suffering from other malignant tumors within 5 years. Thefollowing two conditions can be included: other malignancies treated with a singleoperation, achieving continuous 5-year disease-free survival (DFS); Cured cervicalcarcinoma in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (cancer in situ) and T1 (tumor infiltrating basalmembrane)];
Subjects are known to have genetic abnormalities that have been approved fortargeted drug therapy (non-squamous cell carcinoma subjects are required to haveEGFR or ALK gene tested or provide previous test reports during the screeningperiod)
Cardiovascular and cerebrovascular abnormalities:
Patients with past or existing heart failure, degree II or higher heart block;
Past or present myocardial infarction or unstable angina pectoris, clinicallysignificant supraventricular or ventricular arrhythmias requiring treatment orintervention;
Occurrence of arteriovenous thrombosis/cancer embolus events within 6 months,such as cerebrovascular accident (including transient ischemic attack, cerebralhemorrhage, cerebral infarction requiring clear diagnosis), vascular embolism (including deep vein thrombosis, arterial thrombosis, pulmonary embolism,etc.);
Participated in other drug clinical trials within the past 30 days;
Within 2 weeks before starting the administration, it has been treated with Chinesepatent medicines (including compound Cantharides capsule, Kangai injection,Kanglaite capsule/injection, Aidi injection, Bruceae oil injection/capsule,Xiaoaipingtablet/injection, hualbufatin capsule, etc.) with anti-tumor indicationsspecified in the NMPA approved drug instructions;
Received major surgery other than radical resection of lung cancer within 4 weeksprior to initiation of administration; According to the investigator, the patientwas not eligible to participate in this clinical study for other reasons.
Study Design
Connect with a study center
Tianiin Medical University Cancer Institute & Hospital
Tianjin,
ChinaSite Not Available
Tianjin Medical University Cancer Institute & Hospital
Tianjin 1792947,
ChinaActive - Recruiting

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