Atezolizumab Plus Chemotherapy Followed by Atezolizumab Plus Anlotinib in First-line Therapy for Extensive-stage Small Cell Lung Cancer: A real-world study
- Conditions
- SCLC
- Registration Number
- ChiCTR2400088866
- Lead Sponsor
- The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
(1) Age: =18 years old, regardless of gender;<br>(2) Patients with extensive-stage small cell lung cancer (according to the US Veterans Affairs criteria) confirmed by pathology or cytology, who have not received systemic anti-tumor treatment in the past, or whose previous treatment ended more than 6 months ago and whose disease is now progressing.<br>(3) At least one measurable lesion (the long diameter of the tumor lesion on CT scan is =10 mm, the short diameter of the lymph node lesion on CT scan is =15 mm, and the scanning layer thickness is not greater than 5 mm);<br>(4) The main organ functions are normal, that is, they meet the following criteria: (1) The blood routine examination criteria must meet (no blood transfusion or blood products within 14 days, no use of G-CSF and other hematopoietic stimulating factors for correction):<br>a. HB=80 g/L;<br>b. ANC=1.5×10^9/L;<br>c. PLT=90×10^9/L;<br>(5) Biochemical examinations must meet the following criteria:<br>a. TBIL<1.5ULN;<br>b. ALT and AST<2.5ULN, and for patients with liver metastasis, < 5ULN;<br>c. Serum Cr=1.5ULN;<br>d. Plasma albumin=30g/L;<br>(6) The subjects voluntarily join this study, sign the informed consent form, have good compliance, and cooperate with follow-up.<br>(7) Those who are considered unsuitable for inclusion by the researchers.
(1) Pregnant or lactating women;<br>(2) Those who have been confirmed to be allergic to the trial drug or its excipients.<br>(3) Patients with contraindications to immunotherapy;<br>(4) Subjects who are currently participating in and receiving other research treatments, or the time from the last dose of the previous clinical study to the first treatment of this study is expected to be less than 4 weeks (or 5 half-lives of the previous research drug);<br>(5) Subjects who the investigators believe have a clear bleeding tendency and: imaging (CT or MRI) shows that the tumor invades large blood vessels or surrounds blood vessels with unclear boundaries; or imaging shows obvious pulmonary cavitary or necrotic tumors (marginal adenocarcinoma with cavities can be considered for inclusion after careful discussion by the researchers);<br>(6) Subjects who the researchers believe are not suitable for inclusion.
Study & Design
- Study Type
- Observational study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival;
- Secondary Outcome Measures
Name Time Method Security;Overall Survival;