To Evaluate the Efficacy and Safety of Anlotinib Hydrochloride Capsule in Postoperative Non-pCR Patients With Non-small Cell Lung Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

To explore the effectiveness of anlotinib hydrochloride capsule in postoperative non-pCR non-small cell lung cancer patients with adjuvant intensive therapy

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• The subjects voluntarily joined the study, signed the informed consent, and the compliance was good;

• ≥18 years old (calculated by the date of signing the informed consent); Both men and women; ECOG score 0\

⁃ 1; Expected survival ≥3 months;

• Patients with stage IIA-IIIA NSCLC who had previously received PD-1/PD-L1 inhibitors combined with chemotherapy neoadjuvant therapy and underwent R0 resection for curative purposes before surgery (note: the disease was presented in the American Joint Committee on Cancer (AJCC)/Union International Against Cancer (UICC) 8th edition of lung cancer TNM staging);

• For patients who did not achieve pathological complete response after PD-1/PD-L1 inhibitor combined with chemotherapy neoadjuvant treatment, and the time between the first 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 used during the study period and for 6 months after the end of the study, and that serum or urine pregnancy tests are negative within 7 days prior to study enrollment; Men should agree that effective birth control must be used during the study period and for 6 months after the end of the study period.

Locations
Other Locations
China
Tianjin Medical University Cancer Institute & Hospital
RECRUITING
Tianjin
Contact Information
Primary
Zhansheng
18526812877@163.com
008618526812877
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2027-06-01
Participants
Target number of participants: 64
Treatments
Experimental: experiment
Sponsors
Leads: Tianjin Medical University Cancer Institute and Hospital

This content was sourced from clinicaltrials.gov

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