Esophageal small cell carcinoma
Conditions
Interventions
Treatment group:Tislelizumab combined with induction chemotherapy and concurrent chemoradiotherapy
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients must meet all of the following conditions to be included in this study: 1. Patients voluntarily participate in this study, sign informed consent, have good compliance, and cooperate with follow-up; 2. Age 18-75 years old, including 18 and 75 years old, both men and women; 3. Histologically confirmed esophageal small cell carcinoma; 4. Clinical stage is limited stage (8th edition AJCC TNM clinical staging cTanyNanyM0, stage I-IVa; and stage IVB with supraclavicular lymph node or abdominal lymph node metastasis); 5. A radiotherapy target plan can completely cover the primary tumor lesion, metastatic lymph nodes and lymphatic drainage area; 6. The presence of measurable and/or unmeasurable lesions defined in accordance with the Response Evaluation Criteria for Solid Tumors (RECIST1.1); 7. No previous systemic anti-tumor treatment (including but not limited to systemic chemotherapy, radiotherapy, molecular targeted drug therapy, immunotherapy, biological therapy, local therapy, and other research treatment drugs, etc.); 8. ECOG: 0-1 points; 9. Fresh or archived tumor tissue samples within 6 months (fresh samples are preferred) must be provided for biomarker (such as PD-L1) analysis. The sample type is FFPE tumor tissue block or at least 5 unstained FFPE tumor tissue sections with a thickness of 3-5µm. For subjects who cannot provide tissue samples that meet the above requirements, they can discuss with the sponsor to determine whether to be included in the group; 10. Expected survival period >= 6 months; 11. The function of important organs meets the following requirements (no blood components and cell growth factors are allowed 2 weeks before the start of the screening examination): • Absolute neutrophil count (ANC) >= 1.5×10^9/L; • Platelets >= 100×10^9/L; • Hemoglobin >= 9g/dL; • Serum albumin >= 2.8g/dL; • Total bilirubin = 60mL/min (calculated according to the Cockcroft-Gault formula, see Appendix 2); • International normalized ratio (INR) and activated partial thromboplastin time (APTT) <= 1.5 × ULN (screening is possible for patients using stable doses of anticoagulant therapy such as low molecular weight heparin or warfarin and INR is within the expected therapeutic range of the anticoagulant); 12. Female subjects of childbearing potential should have a urine or serum pregnancy test within 72 hours before the first dose of study drug, and the test result should be negative, and they should be willing to use effective contraceptive methods during the trial and within 3 months after the last dose. Male subjects whose partners are women of childbearing age should use effective contraceptive methods during the trial and within 3 months after the last dose;
Exclusion criteria
Exclusion criteria: Patients with any of the following are not eligible for this study 1. History of esophageal cancer surgery; 2. History of fistula caused by primary tumor infiltration; 3. Higher risk of gastrointestinal bleeding, esophageal fistula or esophageal perforation; 4. Subjects with poor nutritional status, BMI less than 18.5kg/m^2, or PG-SGA score >= 9 points; 5. Major surgery or severe trauma within 4 weeks before the first use of study drug; 6. Uncontrollable pleural effusion, pericardial effusion or ascites that requires repeated drainage; 7. Previously received or is receiving any of the following treatments: a. Anti-PD-1 or anti-PD-L1 antibody treatment, chemotherapy, radiotherapy, targeted therapy; b. Received any investigational drug within 4 weeks before the first use of study drug; c. Corticosteroids are required within 2 weeks before the first use of study drug (every Subjects who are receiving systemic treatment with steroids (prednisone equivalent dose > 10 mg/day) or other immunosuppressants, except for those who use corticosteroids for local esophageal inflammation and prevention of allergies, nausea, and vomiting. For other special cases, it is necessary to communicate with the sponsor. In the absence of active autoimmune diseases, inhaled or topical steroids and adrenocortical hormone replacement at a dose of >10mg/day prednisone are allowed; d. Patients who have received anti-tumor vaccines or live vaccines within 4 weeks before the first dose of the study drug; 8. Patients with any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonitis, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism); excluding vitiligo or asthma/allergy of the same age who have recovered and do not need any intervention as adults; patients with autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormones and type I diabetes mellitus treated with stable doses of insulin can be included; 9. Patients with a history of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation and allogeneic bone marrow transplantation; 10. Subjects with uncontrolled clinical cardiac symptoms or diseases, such as (1) NYHA grade II or above heart failure (2) unstable angina (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; 11. Subjects with severe infection (CTCAE> grade 2) within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, infectious complications, etc. requiring hospitalization; baseline chest imaging examinations indicate active lung inflammation, symptoms and signs of infection within 2 weeks before the first use of the study drug, requiring oral or intravenous antibiotic treatment, but excluding the use of prophylactic antibiotics; 12. Subjects with a history of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis or other uncontrolled acute lung diseases; 13. Subjects with active pulmonary tuberculosis infection found by medical history or CT examination, or a history of active pulmonary tuberculosis infection within 1 year before enrollment, or more than 1 Patients with a history of active pulmonary tuberculosis infection before 2000 years ago but without formal treatment; 14. Subjects with active hepati
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS assessed by independent review committee (IRC); | — |
Secondary
| Measure | Time frame |
|---|---|
| Investigator-assessed PFS;Overall survival (OS);Objective response rate (ORR);Duration of Remission (DoR);Safety: AEs, laboratory test indicators, vital signs, ECG and ECOG score; | — |
Countries
China
Contacts
Public ContactQifeng Wang
Sichuan Cancer Hospital
Outcome results
None listed