Esophageal squamous cell carcinoma
Conditions
Interventions
anlotinib plus ICIs:None
chemotherapy alone:None
Sponsors
Shengjing Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years; 2. Histopathologically confirmed esophageal squamous cell carcinoma (ESCC); 3. Unresectable locally advanced, recurrent, or metastatic disease; 4. Prior to the index line, the patient had received at least one prior exposure to an immune checkpoint inhibitor (ICI), defined as programmed cell death protein 1/programmed death-ligand 1 (PD-1/PD-L1)-based systemic therapy; 5. After discontinuation or completion of the previous ICI-containing regimen, the first subsequent systemic therapy was anlotinib plus ICIs or chemotherapy alone, and the patient met the definitions of the exposure group or control group specified in this protocol; 6. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0–2 at the index date; the most recent record within 7 days before the index date is acceptable; 7. Imaging data available within 28 days before the index date for disease status assessment, including computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography-computed tomography (PET-CT), or other routine clinical examinations; 8. Availability of survival follow-up information sufficient for analysis of the primary endpoint.
Exclusion criteria
Exclusion criteria: 1. Non-squamous histology, or mixed pathology involving esophageal cancer and other tumors that makes efficacy attribution difficult; 2. The index-line treatment strategy cannot be clearly classified as anlotinib plus ICIs or chemotherapy alone; 3. In the exposure group, the interval between initiation of anlotinib and initiation of the ICI was >21 days; 4. Concomitant use of systemic antitumor agents other than the study strategy within 21 days after initiation of the index line, such as other targeted agents, other antiangiogenic agents, or investigational drugs, resulting in unclear exposure attribution; 5. Active gastrointestinal perforation, esophago-airway fistula or mediastinal fistula, or active grade 3 or higher bleeding requiring urgent intervention within 28 days before the index date; 6. Missing key time information, such as the index date, date of death, or date of last follow-up, making analysis of the primary endpoint impossible; 7. Concurrent active malignancy requiring systemic therapy within the past 2 years, except for cured basal cell carcinoma of the skin, carcinoma in situ, or other conditions judged by the investigator not to affect the study outcomes; 8. Medical records considered by the investigator to be severely incomplete and insufficient to support basic baseline assessment, treatment-course assessment, and outcome determination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety profile;Objective response rate;Progression Free Survival; | — |
Countries
China
Contacts
Public ContactYuxiao He
Shengjing Hospital of China Medical University
Outcome results
None listed