Consolidation of Toripalimab and Capecitabine After Chemoradiotherapy in ESCC

Inclusion criteria

• Histologically confirmed squamous cell carcinoma of the esophagus;
• Locally advanced esophageal cancer classified as stage I-IVA (inoperable or patient declined surgery) or stage IVB thoracic esophageal cancer with supraclavicular lymph node metastasis only (AJCC 8th edition) prior to treatment;
• Completion of definitive concurrent chemoradiotherapy without disease progression; radiotherapy dose of 50-50.4 Gy using conventional fractionation and IMRT technique; concurrent platinum- or taxane-based doublet chemotherapy during radiotherapy; ≤4 cycles of induction chemotherapy allowed prior to radiotherapy; PD-1/PD-L1 antibody therapy permitted during induction chemotherapy and radiotherapy; no adjuvant therapy received;
• Enrollment window: within 1-42 days after completion of chemoradiotherapy;
• Age 18-75 years;
• Estimated life expectancy >6 months;
• Eastern Cooperative Oncology Group performance status ≤ 2;
• The function of important organs meets the following requirements: a. white blood cell count (WBC) ≥3.5×109/L, absolute neutrophil count (ANC) ≥1.5×109/L; b. platelets ≥75×109/L; c. hemoglobin ≥9g/dL; d. serum albumin ≥2.8g/dL; e. total bilirubin ≤1.5×ULN, ALT, AST and/or AKP ≤2.5×ULN; f. serum creatinine ≤1.5×ULN or creatinine clearance rate >60 mL/min;
• Ability to understand the trial details and has provided written informed consent.

Exclusion criteria

• Patients who have received antitumor therapy (including adjuvant chemotherapy, surgery, immunotherapy, targeted therapy, etc.) after completion of chemoradiotherapy;
• Stage IVb patients with metastasis to solid organs (e.g., liver, bone, lung, brain, adrenal gland, peritoneum, etc.) at initial diagnosis;
• Known or suspected allergy to the investigational drug(s) or any agent related to the trial regimen;
• Presence of esophageal fistula and/or esophageal hemorrhage prior to enrollment;
• Disease progression after chemoradiotherapy;
• ≥Grade 2 radiation pneumonitis prior to enrollment;
• History of ≥ Grade 3 immune-related adverse events prior to enrollment;
• Prior treatment with targeted drugs;
• History of other malignant tumors besides esophageal cancer, except for non-melanoma skin cancer, carcinoma in situ of the cervix, papillary thyroid carcinoma, or cured early-stage prostate cancer;
• Patients with severe cardiac, pulmonary, hepatic, or renal dysfunction, hematopoietic system diseases, cachexia, or other conditions that make them unfit for chemotherapy;
• Female patients who are pregnant or breastfeeding;
• Inability to provide informed consent due to psychological, familial, social, or other factors;
• Presence of CTC grade ≥2 peripheral neuropathy;
• Patients with a history of diabetes for more than 10 years and poorly controlled blood glucose levels;
• History of autoimmune disease or autoimmune disorders (e.g., colitis, systemic lupus erythematosus, rheumatoid arthritis, uveitis, hypophysitis, hyperthyroidism; not limited to these diseases or syndromes), immunodeficiency history, including HIV positivity, or other acquired/congenital immunodeficiency disorders, or history of organ transplantation or allogeneic bone marrow transplantation;
• History of interstitial lung disease or non-infectious pneumonia;
• Active hepatitis B (HBV DNA ≥2000 IU/mL or 10⁴ copies/mL) or hepatitis C (HCV antibody positive with HCV-RNA above the lower limit of detection);
• Any unstable condition that may jeopardize patient safety or compliance.