Immunotherapy in Combination With Chemoradiotherapy in Unresectable Locally Advanced Esophageal Cancer
Trial Parameters
Brief Summary
SCR-ESCC-02 is a multicenter, phase I/II clinical study to investigate the safety and efficacy of induction immunochemotherapy followed by concurrent chemoradiotherapy with anti-PD-1 therapy in patients diagnosed with locally advanced, unresectable esophageal cancer.
Eligibility Criteria
Inclusion Criteria: 1. Age between 18 and 75 years. 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 3. Clinical stage meeting the criteria of T1N+M0 or T2-4aN0-3M0 based on the 8th UICC-TNM classification. 4. Ineligibility for surgical resections due to patients' unwillingness for surgery, technically unresectable disease, or being medically unfit for surgery. 5. No prior anti-tumor treatment, including surgery, radiotherapy, chemotherapy, immunotherapy, or targeted therapy. 6. Adequate hematological, pulmonary, cardiac, hepatic, renal, and thyroid function. 7. Willingness to use contraception with an adequate method throughout the study. 8. Documented informed consent. Exclusion Criteria: 1. History of malignant disease within the 5 years preceding enrollment or presence of other malignant tumors or non-squamous cell carcinoma components. 2. High risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation as determined by the investigators.