Small Cell Lung Cancer Extensive Stage Clinical Trial
Official title:
Anti-PD-1 Antibody Sintilimab Combined With Anti-angeogensis Inhibitor Anlotinib in Treatment of Extensive-stage Disease Small Cell Lung Cancer After Failure of First Line Standard Therapy : a Single-arm Prospective Phase II Clinical Study
This is a the researchers launched, single-center, prospective, open-label, single arm ,Phase II clinical study of Sintilimab combined with anlotinib in patients with extensive-stage disease small-cell lung cancer to evaluate the efficacy and safety. 23 patients are expected to be enrolled in this study.
Status | Not yet recruiting |
Enrollment | 23 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Aged = 18, regardless of gender . - Histologically or cytologically confirmed small cell lung cancer . - The time after the end of first-line treatment was less than 6 months . - Subjects must have measurable diseases as defined in RECIST v1.1 . - Eastern Cooperative Oncology Group (ECOG) performance status scores are 0-2 . - Adequate hematologic and end organ function . - Capable of understanding the trial nature and voluntarily signing the written informed consent form . Exclusion Criteria: - Radiographic findings showed that the tumor involved large blood vessels or was poorly demarcated from them . - Radiographic findings showed significant pulmonary cavitation or necrotizing tumor . - Active brain metastasis or meningeal metastasis . - With other malignant tumors in the past 5 years, except cancers that have been cured significantly or can be focally cured, e.g. basosquamous carcinoma of skin, or carcinoma cervix in situ . - With Interstitial lung disease, including drug- induced Interstitial lung disease or radiation pneumonitis . - With clinically significant cardiovascular disorder . - Prior exposure to any immune checkpoint inhibitors, including but not limited to other anti-CTLA-4, anti-PD-1 or anti-PD-L1 antibodies . - Prior exposure to anti-VEGFR therapy . - Known hypersensitivity to study drug or any of its excipients . - Treatment with any other investigational agent or participation in another clinical trial within 4 weeks prior to first administration . - Other conditions that the investigator thinks unsuitable in this study . |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Zhejiang Cancer Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ORR | Objective response rate according to RECIST v1.1 | 12 month | |
Secondary | DCR | Disease control rate according to RECIST v1.1 | 12 months | |
Secondary | DoR | Duration of response according to RECIST v1.1 | 12 months | |
Secondary | PFS | Progression-free survival according to RECIST v1.1 | 12 months | |
Secondary | OS | Overall survival | on average of 2 years | |
Secondary | Adverse Event | Evaluation of adverse event rate according to CTCAE v4.03 | 12 months |
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