Esophageal squamous cell carcinoma
Conditions
Interventions
experimental group:Chemoradiotherapy combined with TQB2450
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Adult patients (18 to 70 years old). Eastern Cooperative Oncology Group performance status = 1. Patients with oligorecurrent or oligometastatic diseases and pathologically confirmed esophageal squamous cell carcinoma after initial radical treatment [i.e., completely resected surgery or radical (chemo)radiotherapy]. Definition of oligorecurrence: regional lymph node recurrence and/or anastomotic/esophageal recurrence, the total number of recurrent lesions is 3 or less. Definition of oligometastasis: 1 distant organ with = 3 metastases or 1 extra-regional lymph node station with metastasis. All oligorecurrent or oligometastatic diseases did not receive radiotherapy before enrollment. The measurable lesion was determined by the investigator based on the RECIST 1.1 assessment. The function of vital organs meets the following requirements: white blood cell count (WBC) = 4.0×10^9/L, neutrophil absolute count (ANC) = 1.5 × 10^9 / L; platelets = 100 × 10^9 / L; hemoglobin = 90g / L; total bilirubin = 1.5 × ULN, ALT and AST = 2.5 × ULN; serum creatinine = 1.5×ULN; prothrombin time = 1.5 × ULN, activated partial thromboplastin time = 1.5 × ULN. Estimated life expectancy > 3 months. The patient is voluntarily enrolled and obtained the informed consent form signed by the patient or his legal representative.
Exclusion criteria
Exclusion criteria: A history of malignancies other than esophageal cancer before enrollment, excluding non-melanoma skin cancer or in situ cervical cancer. Female patients who are pregnant or during lactation. Active autoimmune diseases or a history of autoimmune diseases (including but not limited to these diseases or syndromes, such as colitis, hepatitis, hyperthyroidism). A history of organ transplantation or allogeneic bone marrow transplantation. The patient has any symptoms that required systemic corticosteroid therapy or other immunosuppressive therapy within two weeks. Active infection [active hepatitis B (HBV DNA = 500 IU/mL), hepatitis C (positive for hepatitis C antibody, and HCV-RNA levels higher than the lower limit of the assay), a positive HIV test result]. A history of interstitial lung disease. Patients with uncontrolled pleural or peritoneal effusion. The patient is allergic to any investigational drug and its excipients. The investigator judged that patients could not cooperate with the treatment or have other factors that might cause them to be forced to terminate the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Local control;Objective response rate;Overall survival;Duration of response;Toxicity; | — |
Countries
China
Contacts
Public ContactChengcheng Fan
Henan Cancer Hospital
Outcome results
None listed