Esophagus cancer
Conditions
Interventions
Experimental group:Enrolled patients will initially receive 4 cycles of "immunotherapy plus chemotherapy" as initial treatment. The specific regimen is as follows: the immunotherapy agent is an PD-1 i
the chemotherapy agents are selected from Paclitaxel (175mg/m2, d1, q3w), or Docetaxel (75mg/m2, d1, q3w), or Irinotecan (270mg/m2, d1, q3w). Then, they will receive immunotherapy alone as maintenance
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Voluntary participation and written informed consent obtained. 2.Aged >= 18 years, regardless of gender. 3.Histologically or pathologically confirmed local recurrence of esophageal squamous cell carcinoma (ESCC) after prior definitive radiotherapy or chemoradiotherapy. 4.With or without regional lymph node metastasis, but absence of distant metastasis. 5.Medically inoperable or unwilling to undergo surgery. 6.Eligible for and able to tolerate chemotherapy, radiotherapy, and immunotherapy. 7.Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2. 8.Life expectancy >= 3 months. 9.No severe dysfunction of hematopoietic system, heart, lung, liver, kidney, or immunodeficiency.
Exclusion criteria
Exclusion criteria: 1.Presence of esophageal perforation or hematemesis. 2.Development of distant metastasis in patients with locally recurrent esophageal squamous cell carcinoma after prior definitive radiotherapy or chemoradiotherapy. 3.History of drug abuse, chronic alcoholism, or diagnosed with AIDS. 4.History of myocardial infarction within = 6 months. Patients with a history of myocardial infarction > 6 months prior can only be enrolled if a myocardial thallium scan shows no evidence of myocardial ischemia and approval for chemotherapy is granted by a cardiologist. 5.Uncontrolled seizures or psychiatric illness that compromises the ability to provide informed consent or comply with the study protocol. 6.History of severe allergic reactions or known hypersensitivity to any components of the proposed treatments. 7.Any other condition deemed by the investigator as inappropriate for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the 2-year post-recurrence survival of patients with locally recurrent esophageal squamous cell carcinoma after radical chemoradiotherapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the progression-free survival (PFS) of patients with locally recurrent esophageal squamous cell carcinoma (ESCC) after radical chemoradiotherapy; | — |
Countries
China
Contacts
Public ContactYe Jinjun
Jiangsu Cancer Hospital
Outcome results
None listed