esophageal squamous cell carcinoma
Conditions
Interventions
Group1:Tislelizumab combined with chemotherapy
Sponsors
Peking University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Patients aged 18-75 years; 2.Esophageal squamous cell carcinoma was diagnosed by histological or cytological examination; 3.ESCC patients with AJCC version 8 stage T3-T4A, operable or N+ (note: supravian lymph node metastasis is not excluded), tumor is located in thoracic esophageal cancer, the lesion is more than 5 cm away from the annular pharyngeal muscle; 4.Complete imaging examination without distant metastasis; 5.No previous treatment related to tumor disease (including radiotherapy and chemotherapy, targeted, immunization or traditional Chinese medicine therapy); 6.The quality of life was evaluated according to the activity status scale developed by Eastern Cooperative Oncology Group (ECOG), and patients with ECOG score 0-1 were included; 7.Adequate organ and bone marrow function; 8.With the consent and informed consent signed by the applicant, he/she shall comply with the planned visit, research treatment, laboratory examination and other test procedures.
Exclusion criteria
Exclusion criteria: 1.Participate in drug therapy for other clinical studies; Vaccination history of live attenuated vaccines; 2.Radiotherapy for esophageal squamous cell carcinoma is planned during the study period; 3.Patients with esophageal squamous cell carcinoma complicated with interstitial pneumonia or pulmonary fibrosis; 4.Prior use of immunosuppressive drugs or glucocorticoids within 2 weeks before the start of treatment; 5.Any active autoimmune disease or a history of autoimmune diseases (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, the pituitary gland inflammation, vasculitis, nephritis, thyroid function, thyroid function decrease), or a known history of history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 6.A known history of human immunodeficiency virus (HIV); 7.Patients with active viral hepatitis B and C. Hepatitis B virus (HBV) DNA > 1000 copies/mL in patients with acute or chronic active hepatitis B or C; Hepatitis C virus RNA > 10^3 copies/mL; Hepatitis B surface antigen (HbsAg) and anti-HCV antibody positive; 8.Subjects with prior malignancies are excluded unless complete elimination has been achieved at least 5 years prior to study entry and no additional treatment is required or expected during the study period (exceptions include, but are not limited to, basal or squamous cell skin cancer, superficial bladder cancer, or prostate, cervical, or breast carcinoma in situ); 9.Known allergy to the study drug or any of its excipients, or severe allergic reaction to other monoclonal antibodies; 10.Pregnant or lactating women and women of childbearing age do not take reliable contraceptive measures; 11.The presence, in the investigator's judgment, of comorbid diseases (e.g., poorly controlled hypertension, poorly controlled diabetes, poorly controlled neurological or psychiatric diseases) or any other conditions that seriously endanger the safety of the subjects, may confuse the study results, or may interfere with the completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete response rate, pCR rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| major pathological response rate, MPR rate;R0 resection rate;Objective response rate, ORR;Disease-free survival, DFS;Overall survival, OS; | — |
Countries
China
Contacts
Public ContactNan wu
Peking University Cancer Hospital
Outcome results
None listed