patients with locally advanced esophageal squamous cell carcinoma who are potentially or marginally resectable
Conditions
Interventions
Low-dose radiotherapy combined with immuno-chemotherapy:Low-dose radiotherapy combined with chemotherapy and immunotherapy
Sponsors
Army Medical Center of PLA
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Ages 18 to 80, both genders; 2.confirmed primary squamous cell carcinoma of the thoracic esophagus; 3.The multidisciplinary team (MDT) concluded that the initial diagnosis was esophageal squamous cell carcinoma (ESCC) that could not be resected radically (R0). The specific staging was: primary tumor not resectable R0 (cT3-4NxM0), and/or lymph node not resectable R0 (cT2-4N+M0), stages II-IVA. 4.No prior local or systemic antitumor therapy for esophageal cancer; 5.The function of vital organs meets the following requirements: Absolute neutrophil count >= 1.5 × 10 ^ 9/L; platelet >= 80 × 10 ^ 9/L; hemoglobin >= 80 × 10 ^ 9/L; total bilirubin <= 1.5 upper limit of normal value; Serum creatinine is within normal value; Alanine aminotransferase and aspartate aminotransferase <= 2.5 upper limit of normal value; No serious complications or other major diseases that have not been cured in the past; 6.Fertile female participants, and male participants whose partners are of childbearing age, need to use a medically approved contraceptive during the study treatment and for at least 6 months after the last chemotherapy; 7. Female subjects with fertility and male subjects with reproductive age partners need to use a medically approved contraceptive measure during the study treatment and at least 6 months after the last chemotherapy; 8. The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1.Patients with esophagotracheal or esophageal mediastinal fistula within 6 months before first medication; 2.Patients with poor lung function or chronic interstitial lung disease; 3.Known hypersensitivity or hypersensitivity reactions to any component of biologics or PD-1 monoclonal antibody preparations produced by China hamster ovary (CHO) cells; 4.history of allergy to albumin-bound paclitaxel, paclitaxel, carboplatin, and other platinum-based drugs; 5.Participants were also enrolled in another clinical study, unless it was an observational (non-interventional) clinical study or an intervention clinical study with follow-up; 6.Participants who received systemic treatment with corticosteroids (equivalent to 10mg of prednisone per day) or immunosuppressants within 2 weeks before first use of the study drug; 7.those who have received an antitumor vaccine or a live vaccine within 4 weeks before the first dose of the study drug; 8.active autoimmune disease, history of autoimmune disease;Except for patients with vitiligo or recovered childhood asthma/allergy, who do not need any intervention after adulthood; Autoimmune mediated hypothyroidism treated with a stable dose of thyroid hormone replacement therapy; Type 1 diabetes mellitus treated with a stable dose of insulin 9.History of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation and allogeneic bone marrow transplantation; 10.patients with poorly controlled cardiovascular symptoms or disease; 11.Patients with active hepatitis B or C; 12.Patients with active tuberculosis; 13.Serious infection within 4 weeks before first use of study drug;Such as severe pneumonia, bacteremia and infection complications requiring hospitalization; Baseline chest imaging showed active pulmonary inflammation, symptoms and signs of infection within 2 weeks before the first use of the study drug, or the need for oral or intravenous antibiotic treatment, except for the prophylactic use of antibiotics 14.had undergone major surgery within 28 days before treatment;Or expected to undergo major surgery during the study 15.diagnosed with any other malignancy within 5 years before first use of study drug;Nausea tumors with low risk and death risk (5-year survival rate>90%) are excluded, such as well treated basal cell or squamous cell skin cancer or cervical cancer in situ. 16.Women who are pregnant or breastfeeding and who refuse or are unable to use contraception; 17.The investigator determined that the subject had other factors that could have led to forced discontinuation of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event (AE);Overall Survival (OS);Objective Response Rate (ORR);Disease-free survival (DFS);Pathological complete response rate (pCR);Major Pathological response;Surgical conversion rate; | — |
Countries
China
Contacts
Public ContactMengxia Li
Army Medical Center of PLA
Outcome results
None listed