Esophageal small cell carcinoma
Conditions
Interventions
Adebrelimab plus chemotherapy group:adebrelimab: 1200 mg, ivgtt d1, Q3W
EP regimen: etoposide 100 mg/m2 intravenous infusion d1-3, cisplatin 25 mg/m2 intravenous infusion d1-3, Q3W
or EC regimen: etoposide 100 mg/m2 intravenous infusion d1-3, carboplatin AUC 5-6 intravenous infusion d1, Q3W.
After 4 cycles of administration, adebrelimab 1200 mg, IVGTT D1, 21 days as a cycle of m
Sponsors
Anyang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18~75 years old, male or female; 2. Pathologically confirmed esophageal small cell carcinoma; 3. Unresectable or metastatic esophageal small cell carcinoma; 4. Have not received prior systemic therapy for esophageal small cell carcinoma; 5. Have at least one measurable lesion (according to RECIST 1.1 criteria); 6. ECOG score of 0-1 points; 7. Estimated survival time> 3 months; 8. Laboratory tests performed within 7 days prior to the first dose meet the following conditions: (1) White blood cell count (WBC) >= 3.0 × 10^9/L, absolute neutrophil count (ANC) >= 1.5 × 109/L, platelet count (PLT) >= 100× 10^9/L, hemoglobin (HGB) >= 90 g/L, and no transfusion or other hematopoietic factor therapy within the previous 14 days; (2) alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) = 30 g/L; (3) serum creatinine (CRE) = 60 mL/min (Cockcroft-Gault formula); (4) International normalized ratio (INR) 1.2L, FEV1%>40%; c) Liver function: Child-Pugh grade 5-6 points; 10. For premenopausal females (postmenopausal females must have been postmenopausal for at least 12 months to be considered non-childbearing potential), with a negative serum pregnancy test result, male subjects (including female spouses of male subjects of childbearing potential) as well as female subjects of childbearing potential must have contraception from the first dose of study drug to 6 months after the last dose of study drug; 11. Obtain informed consent signed by the subject or his/her legal representative; 12. Can cooperate with the completion of study procedures and follow-up examinations.
Exclusion criteria
Exclusion criteria: 1. Allergy to the study drug or excipients or their analogues, severe allergic reaction to any kind of monoclonal antibody; 2. Previous presence of active, likely to recur or undiagnosed autoimmune diseases, skin diseases (vitiligo, psoriasis, alopecia), well-controlled type I diabetes mellitus, hypothyroidism (thyroid hormone replacement therapy only), and other diseases that are not expected to recur without external stimuli are allowed to be enrolled; 3. History of allogeneic stem cell transplantation or organ transplantation; 4. Combined with interstitial pneumonia or interstitial lung disease, non-infectious pneumonia; 5. History of gastrointestinal perforation and/or fistula, intra-abdominal abscess, visceral fistula, history of intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), inflammatory bowel disease or extensive bowel resection (including partial colectomy or extensive small bowel resection complicated by chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea within 10 mg/day prednisone or equivalent) or other immunosuppressants within 14 days = grade 2 heart failure, b) severe/unstable angina, c) myocardial infarction within 6 months =2+ and 24-hour urine protein quantification >= 1.0 g; 11. Pulmonary tuberculosis (TB) requiring to receive/receive/receive anti-tuberculosis therapy within 1 year prior to the first study dose; 12. Human immunodeficiency virus infection (HIV1/2 antibody positive); 13. Acute or chronic active hepatitis B and/or hepatitis C: hepatitis B virus surface antigen (HBsAg) positive/hepatitis B virus core antibody (HBcAb) positive and hepatitis B virus DNA positive (HBV DNA >200 IU/ml or 103 copies/ml), if HBsAg/HBcAb positive, HBV DNA <= 200 IU/ml or 103 copies/ml can be enrolled, but entecavir or other
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;OS;AEs; | — |
Countries
China
Contacts
Public ContactCao Heng
Anyang Cancer Hospital
Outcome results
None listed