esophageal cancer
Conditions
Interventions
DT=4000cGy/20f/28d radiotherapy regimen group:The patients radiotherapy regimen was DT=4000cGy/20f/28d with IMRT/VMAT±IGRT radiation therapy technique. Evaluation was performed by barium esophageal me
DT=3000cGy/15f/21d radiotherapy regimen group:The patients radiotherapy regimen wasDT=3000cGy/15f/21d with IMRT/VMAT±IGRT radiation therapy technique. Evaluation was performed by barium esophageal mea
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Inclusion criteria: all patients with tumor infiltration depth exceeding the intrinsic muscular layer of the mucosa but not breaching the submucosal layer who were considered T1 superficial esophageal squamous cell carcinoma and were seen and treated in the outpatient oncology clinic, outpatient gastroenterology clinic, and gastrointestinal endoscopy center of West China Hospital. 1)18-75 years of age; 2) Histopathologic diagnosis of esophageal squamous carcinoma; 3) Patient refuses surgical esophagectomy; 4) Clinical stage T1N0M0 (AJCC, 8th edition, 2017); 5) not having received tumor-related treatment; 6) Evaluation based on the Active Status Scale developed by the Eastern Cooperative Oncology Group (ECOG) and inclusion of patients with an ECOG score of 0-1; 7)Adequate organ function: a) Blood count (not transfused, not on granulocyte colony-stimulating factor (G-CSF), not corrected with other medications within 14 days prior to treatment) i.Neutrophil count (NE) >1500/µL; ii.Hemoglobin count (HGB) > 8.0 g/dL; iii. platelet count (PLT) >100,000/µL. b) Blood biochemistry (liver and kidney function) i. Serum creatinine (Cr) = 1.5×upper limit of normal (ULN); ii.Total bilirubin (TBIL) = 1.5 x ULN; Total bilirubin (TBIL) = 1.5 x ULN; iii. Glutamine aminotransferase (AST) or alanine aminotransferase (ALT) levels = 2 x ULN; 8) Sign the informed consent form to participate in this clinical trial.
Exclusion criteria
Exclusion criteria: Exclusion criteria: patients with low-grade intraepithelial neoplasia, high-grade intraepithelial neoplasia, mucosal lamina propria, mucosal muscularis propria, and submucosal superficial invasive carcinoma that could be curatively resected by endoscopic consideration; patients with invasive esophageal squamous cell carcinoma of the intrinsic muscularis propria and deeper levels that were considered by a comprehensive evaluation of the gastroscopy, ultrasonography, and CT of the thorax prior to the surgery; and patients who were unable to tolerate the endoscopic surgery and the follow-up after the surgery. 1) Patients who have received the following medical interventions within four weeks prior to treatment: a) Drug therapy participating in other clinical studies; b) History of live attenuated vaccination. 2) Previously received anti-programmed death-1 (PD-1)/PD-1 ligand (PD-L1) monoclonal antibody, cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibody or other immunotherapy, radiation therapy, molecular targeted therapy or chemotherapy. 3) Patients who are completely unable to eat; 4) Pre-existing esophageal perforation or high risk of esophageal perforation 5) Patients with combined interstitial pneumonia, non-infectious pneumonia or pulmonary fibrosis; 6) Prior use of immunosuppressive drugs glucocorticoids within 7 days prior to initiation of therapy; 7) Presence of any active autoimmune disease or history of autoimmune disease (including, but not limited to: autoimmune hepatitis, interstitial pneumonitis, uveitis, enterocolitis, hepatitis, pituitary gland inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism), or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 8) Active infection prior to treatment (e.g., requiring intravenous antibiotics, antifungal or antiviral medications), or unexplained fever >38.5°C during screening/prior to first dose; 9) Any other malignancy diagnosed prior to treatment; 10) Pregnant or lactating women and women of childbearing age not using reliable contraception. 11) Presence of concomitant diseases that, in the investigator's judgment, seriously jeopardize the safety of the subject, may confound the results of the study, or interfere with the subject's ability to complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Local recurrence rate;Adverse event rate; | — |
Countries
China
Contacts
Public ContactBingwen Zou
West China Hospital, Sichuan University
Outcome results
None listed