About this trial
This is an investigator-initiated, single-arm, exploratory clinical study.The study population consisted of treatment naive advanced esophageal squamous cell carcinoma patients. The purpose of this study was to evaluate the efficacy and safety of immunotherapy combined with chemotherapy and residual lesions irradiation of esophageal squamous cell carcinoma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed with Stage IV esophagus squamous cell carcinoma.
Expected survival time ≥3 months
Enrolled patients must have at least one measurable lesion conforming to the RECIST V1.1 definition.
Physical fitness ECOG score of 0 or 1
Disqualifiers
Known or suspected history of active autoimmune diseases, autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes)
Have a history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency disease, or history of organ transplantation and bone marrow transplantation;Interstitial lung disease, drug-induced pneumonia,requiring steroid therapy or active pneumonia with clinical symptoms or severe pulmonary dysfunction;
There are clinical symptoms or diseases of the heart that are not well controlled, such as: (1) heart failure of NYHA class 2 or higher (2) unstable angina (3) myocardial infarction within 24 weeks (4) clinical need for treatment or Interventional supraventricular or ventricular arrhythmia;
Have a tendency to hereditary bleeding or coagulopathy. Clinically significant bleeding symptoms or clear bleeding tendency within 3 months prior to enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood++ and above;
Trial design
Single group
Treatments tested in this trial
TP regimen (cis-platinum ; Tocetaxel ) combined with PD-1 inhibitors(Sintilimab)
DrugTP regimen (cis-platinum ; Tocetaxel ) combined with PD-1 inhibitors(Sintilimab)for 4 cycles, then irradiation of the residual lesions for 50Gy/2Gy/25f. After complete irradiation, sintilimab is administered every 21 days a cycle for additional 13 cycles.
Treatment groups
Trial outcomes
Primary outcomes
Overall survival (OS)
time from enrollment to patients death
Progression-free survival (PFS)
time from disease progression or patient death
Secondary outcomes
overall response rate (ORR)
complete response plus partial response
toxicities
toxicities according to CTCAE 5.0
Sponsors and contacts
Click on the lead sponsor to view all of their trials.