Locally advanced resectable esophageal squamous cell carcinoma
Conditions
Interventions
expeimental group:Sequential treatment of reduced chemotherapy and Pembeolizumab
Sponsors
Ethics Committee of the First Medical Center of PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Eligible patients for this study must meet all of the following criteria: 1. Aged 18-75 years, both male and female; 2. Patients with esophageal squamous cell carcinoma confirmed by histology or cytology; 3. Resectable tumor by surgical evaluation; 4. Patients who can be operated after preoperative evaluation 5. ECoG score 0-1; 6. TNM stage was stage II or stage IIIa; 7. The function of main organs was normal, and there was no serious abnormal function of blood, heart, lung, liver and kidney and immune deficiency diseases. The laboratory examination meets the following requirements: (1) Blood routine examination should be consistent with (no blood transfusion within 14 days) a. HGB >= 110g/L; b. WBC >= 4.0 * 10^9/L NEUT >= 2.0 * 10^9/L; c. PLT >= 100 * 10^9/L. (2) Biochemical tests should meet the following criteria: BIL = 50ml / min (Cockcroft Gault formula); (3) Fecal occult blood (-); (4) The urine routine test was normal, or the urine protein was < + +, or the 24-hour urine protein volume was less than 1.0 G; 8. Thyroid stimulating hormone (TSH) <= upper limit of normal value (ULN); if abnormal, T3 and 4 levels should be investigated, and if T3 and T4 levels are normal, they can be selected; 9. Coagulation function was normal, no active bleeding and thrombosis. a. International normalized ratio INR <= 1.5 * ULN; b. APTT <= 1.5 * ULN; c. Prothrombin time Pt <= 1.5uln. 10. Women of childbearing age should have a pregnancy test (serum or urine) negative within 14 days before enrollment. From the beginning of the screening period to the last use of the study drug, fertile women and men must voluntarily use recognized and effective contraceptive measures; 11. The patients voluntarily joined the study and signed the informed consent form (ICF). They had good compliance and could follow up the efficacy and adverse reactions according to the requirements of the protocol.
Exclusion criteria
Exclusion criteria: Subjects who met the following criteria were not eligible for this study: 1. In the past two years, there are known malignant tumors other than esophageal cancer that are developing or need active treatment, or are expected to need active treatment within two years; 2. Currently participating in the intervention clinical research treatment, or receiving other research drugs or using research instruments within 4 weeks before the first administration; 3. Have received the following therapies in the past: anti PD-1, anti-PD-L1 or anti-PD-L2 drugs, or another drug that stimulates or synergistically inhibits T-cell receptors (e.g., CTLA-4, OX-40, CD137); 4. Systematic systemic treatment with Chinese patent medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use of pleural effusion) with anti-tumor indications within 2 weeks before the first administration; 5. Active autoimmune diseases requiring systemic treatment (e.g. use of disease remission drugs, glucocorticoids or immunosuppressants) occurred within 2 years before the first administration. Replacement therapy (e.g. thyroxine, insulin or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) is not considered as systemic therapy; 6. The study was receiving systemic glucocorticoid therapy (excluding nasal, inhaled or other local glucocorticoids) or any other form of immunosuppressive therapy within 7 days prior to the first administration of the drug; Note: physiological dose of Glucocorticoid (<=10 mg / day of prednisone or equivalent drugs) is allowed; 7. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 8. Those who are known to be allergic to paclitaxel or paclitaxel in this study; 9. The toxicity and / or complications caused by any intervention have not been fully recovered before treatment (i.e. <= grade 1 or reaching baseline, excluding fatigue or alopecia); 10. Known history of HIV infection (i.e. HIV 1 / 2 antibody positive); 11. Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number greater than the upper limit of normal value in the laboratory of the research center); Note: subjects who meet the following criteria can also be included in the study: 1) Before the first administration, HBV viral load was less than 1000 copies / ml (200 IU / ml), and subjects should receive anti HBV treatment during the whole study chemotherapy drug treatment to avoid virus reactivation; 2) For subjects with anti HBC (+), HBsAg (-), anti HBS (-) and HBV viral load (-), preventive anti HBV treatment was not required, but virus reactivation was closely monitored. 12. Active HCV infected subjects (HCV antibody positive and HCV-RNA level higher than the detection limit); 13. Vaccinate live vaccine within 30 days before the first administration (cycle 1, day 1); Note: it is allowed to receive inactivated virus vaccine for seasonal influenza within 30 days before the first administration; however, live attenuated influenza vaccine for intranasal administration is not allowed. 14. Pregnant or lactating women; 15. The presence of any serious or uncontrollable systemic disease, suc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;MPR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serious drug-related adverse events (90 days after the first administration of Pembeolizumab or 30 days after operation, whichever occurs later);PCR;DFS;Occurrence of surgical complications (intraoperative and perioperative complications; | — |
Countries
China
Contacts
Public ContactYang Bo
The First Medical Center of PLA General Hospital
Outcome results
None listed