combination of toripalimab and chemoradiotherapy in esophageal cancer

Conditions: Unresectable Esophageal Cancer

Summary: definitive chemoradiotherapy (crt) is the standard treatment option for unresectable esophageal cancer (ec). however, as high as more than 40% of ec patients experienced locoregional recurrence after concurrent crt. immunotherapy targeting the pd-1/pd-l1 checkpoints has demonstrated promising activity in advanced ec. the aim of this study was to evaluate the efficacy and safety of the combination of toripalimab (an anti-pd-1 antibody) combined with definitive crt in locally advanced esophageal squamous cell carcinoma (escc).


Eligibility criteria:
inclusion criteria: 1. histologically confirmed squamous cell carcinoma of the esophagus; 2. absence of hematogenous metastasis disease, confirmed by endoscopic ultrasound (eus) and pet-ct scan (according to uicc tnm version 8); 3. not suitable for surgery (either for medical reasons or patient's choice); 4. age at diagnosis 18 to 70 years; 5. no prior cancer therapy; 6. estimated life expectancy \>6 months; 7. eastern cooperative oncology group performance status ≤ 2 8. no history of concomitant or previous malignancy; 9. the function of important organs meets the following requirements: a. white blood cell count (wbc) ≥ 4.0×109/l, absolute neutrophil count (anc) ≥ 1.5×109/l; b. platelets ≥ 100×109/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; 10. ability to understand the study and sign informed consent. exclusion criteria: 1. patients who have been treated previously with anti-tumor therapy (including chemotherapy, radiotherapy, surgery, immunotherapy, etc.); 2. patients with hematogenous metastasis disease at diagnosis; 3. known or suspected allergy or hypersensitivity to monoclonal antibodies, any ingredients of toripalimab, and the chemotherapeutic drugs paclitaxel or cisplatin; 4. patients who have a preexisting or coexisting bleeding disorder; 5. female patients who are pregnant or lactating; 6. inability to provide informed consent due to psychological, familial, social and other factors; 7. presence of ctc grade ≥ 3 peripheral neuropathy; 8. a history of malignancies other than esophageal cancer before enrollment, excluding non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer 9. a history of diabetes for more than 10 years and poorly controlled blood glucose levels; 10. patients who cannot tolerate chemoradiotherapy due to severe cardiac, lung, liver or kidney dysfunction, or hematopoietic disease or cachexia. 11. active autoimmune diseases, a history of autoimmune diseases (including but not limited to these diseases or syndromes, such as colitis, hepatitis, hyperthyroidism), a history of immunodeficiency (including a positive hiv test result), or other acquired or congenital immunodeficiency diseases, a history of organ transplantation or allogeneic bone marrow transplantation; 12. a history of interstitial lung disease or non-infectious pneumonia; 13. a history of active pulmonary tuberculosis infection within 1 year or a history of active pulmonary tuberculosis infection more than 1 year ago but without formal anti-tuberculosis treatment; 14. presence of active hepatitis b (hbv dna ≥ 2000 iu/ml or 104 copies/ml), hepatitis c hepatitis c antibody, and hcv-rna levels higher than the lower limit of the assay).

Keywords: esophageal squamous cell carcinoma definitive chemoradiotherapy toripalimab clinical complete response