Esophageal cancer
Conditions
Interventions
Experimental group: For the primary esophageal lesion, radiotherapy is administered using IMRT (Intensity-Modulated Radiation Therapy) technology, DT (Dose per Treatment) 1.8-2Gy/f, with a total of 50
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age 18-75, both men and women are eligible; (2) Initially diagnosed with esophageal squamous carcinoma through histology or cytology; (3) Imaging confirmed single organ =3 metastatic foci or 1 extra-regional lymph node metastasis; (4) Assessed by a thoracic surgeon as inoperable; (5) No prior systemic antitumor treatment after diagnosis; (6) Participants willingly join this study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up; (7) Female participants of childbearing potential and male participants with partners of childbearing age must use a medically approved contraceptive method during the study treatment period and for at least 6 months after the last chemotherapy; (8) The function of vital organs must meet the following requirements: 1) Absolute neutrophil count =1.5×10^9/L; 2) Platelets =80×10^9/L; 3) Hemoglobin =80×10^9/L; 4) Total bilirubin =1.5 times the upper limit of normal; 5) Serum creatinine within normal limits; 6) Alanine aminotransferase, aspartate aminotransferase =2.5 times the upper limit of normal; 7) No unhealed serious comorbidities or other major diseases in the past.
Exclusion criteria
Exclusion criteria: (1) Received any kind of systemic anticancer treatment before the first use of the investigational drug; (2) Concurrent enrollment in another clinical study, unless it's an observational (non-interventional) clinical study; (3) Need for systemic treatment with corticosteroids (more than 10 mg Prednisone equivalent daily) or other immunosuppressants within 2 weeks prior to the first use of the investigational drug; (4) Vaccinated with a tumor vaccine or received a live vaccine within 4 weeks prior to drug administration; (5) Has an active autoimmune disease, or a history of autoimmune disease; exceptions are cured childhood asthma/allergies with no interventions needed in adulthood; autoimmune-mediated hypothyroidism being stably treated with hormone replacement therapy; Type I diabetes treated with a stable dose of insulin; (6) Experienced severe interference (CTCAE= Grade 3) within 4 weeks before the first use of the investigational drug; baseline chest imaging indicating active pulmonary inflammation, or symptoms and signs of infection needing oral or intravenous antibiotics within 2 weeks prior to the first use; (7) History of interstitial lung disease; (8) Active Hepatitis B (HBV DNA=2000 IU/ml or 104 copies/ml) or Hepatitis C (positive for HCV antibody and HCV-RNA above the analytical method's lower limit); (9) Pregnant or lactating women; (10) Unhealed serious comorbidities or other major diseases in medical history; (11) Considered by the thoracic surgeon eligible for curative surgery; (12) Participant withdrawal or discontinuation of the study treatment criteria include: 1) Participant withdraws informed consent, refusing further follow-up; 2) Participant's death; 3) Toxicity intolerable, occurrence of a serious AE; 4) Clinician's judgment of noticeable clinical worsening or significant decline in physical condition; 5) Researcher considers other necessary cases to terminate study drug treatment; 6) Pregnancy; 7) Loss to follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free-Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Overall Survival;Treatment-related adverse events (AEs) ; | — |
Countries
China
Contacts
Public ContactShisuo Du
Zhongshan Hospital, Fudan University
Outcome results
None listed