Esophageal small cell cancer
Conditions
Interventions
Treatment group:Adebrelimab combined with etoposide and platinum
Sponsors
Shandong Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-85 years old, male and female; 2. Histologically or cytologically confirmed extensive stage small cell esophageal cancer; 3. ECOG physical condition score 0~2; 4. No previous first-line systematic therapy for small cell esophageal cancer; 5. Estimated survival time >=8 weeks; 6. Measurable lesions as defined by the RECIST standard v1.1 exist: A previously irradiated lesion can be considered a measurable lesion only if it shows clear disease progression after radiotherapy and is not the only lesion. 7. Adequate organ function; 8. To provide tumor tissue specimens, either archived within 6 months prior to the first dose of the investigational drug, or freshly obtained. The specimens should meet the requirements of formalin fixed and paraffin-embedded (FFPE) tumor tissue blocks, which can be cut into no less than 20 5µm thick slices for staining and detection (if less than 20 slices need to be negotiated with the sponsor and agreed to be included in the group). The samples without fine needle biopsy and the cell smear with pleural effusion drainage and centrifugation are not sufficient for biomarker detection. 9. Patients joined the study, signed informed consent, had good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1.BMI 10 mg prednisone per day) or other immunosuppressants within 2 weeks prior to initial use of the study drug, except for corticosteroids for local esophageal inflammation and prevention of allergy, nausea, and vomiting. Other special cases require communication with the researcher. In the absence of active autoimmune disease, inhaled or topical steroids and adrenocortical hormone replacement at doses > 10mg/ day of prednisone efficacy are permitted; f. Those who have received anti-tumor vaccine or have received live vaccine within 4 weeks prior to the first administration of the investigational drug; g. Major surgery or severe trauma within 4 weeks prior to the first use of the study drug; 7. The toxicity of previous anti-tumor therapy did not return to Class 2), such as severe pneumonia, bacteremia, and infection complications requiring hospitalization, occurred within 4 weeks prior to the first use of the study drug; Baseline chest imaging findings indicate active lung inflammation, sig
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;OS; | — |
Countries
China
Contacts
Public ContactWei Huang
Shandong Cancer Hospital and Institute, Shandong First Medical University, Shandong Academy of Medical Sciences
Outcome results
None listed