Combination of Toripalimab and Chemoradiotherapy in Esophageal Cancer

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    42
  • sponsor
    Mian XI
Updated on 22 January 2021

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).

Details
Condition Unresectable Esophageal Cancer
Treatment Intensity-modulated radiotherapy, Toripalimab, Paclitaxel/cisplatin
Clinical Study IdentifierNCT04005170
SponsorMian XI
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 70 yrs?
Gender: Male or Female
Do you have Unresectable Esophageal Cancer?
Do you have any of these conditions: Do you have Unresectable Esophageal Cancer??
Histologically confirmed squamous cell carcinoma of the esophagus
Absence of hematogenous metastasis disease, confirmed by endoscopic ultrasound (EUS) and PET-CT scan (according to UICC TNM version 8)
Not suitable for surgery (either for medical reasons or patient's choice)
Age at diagnosis 18 to 70 years
No prior cancer therapy
Estimated life expectancy >6 months
Eastern Cooperative Oncology Group performance status 2
No history of concomitant or previous malignancy
The function of important organs meets the following requirements: a. white blood cell count (WBC) 4.0109/L, absolute neutrophil count (ANC) 1.5109/L; b. platelets 100109/L; c. hemoglobin 9g/dL; d. serum albumin 2.8g/dL; e. total bilirubin 1.5ULN, ALT, AST and/or AKP 2.5ULN; f. serum creatinine 1.5ULN or creatinine clearance rate >60 mL/min
Ability to understand the study and sign informed consent

Exclusion Criteria

Patients who have been treated previously with anti-tumor therapy (including chemotherapy, radiotherapy, surgery, immunotherapy, etc.)
Patients with hematogenous metastasis disease at diagnosis
Known or suspected allergy or hypersensitivity to monoclonal antibodies, any ingredients of Toripalimab, and the chemotherapeutic drugs paclitaxel or cisplatin
Patients who have a preexisting or coexisting bleeding disorder
Female patients who are pregnant or lactating
Inability to provide informed consent due to psychological, familial, social and other factors
Presence of CTC grade 3 peripheral neuropathy
A history of malignancies other than esophageal cancer before enrollment, excluding non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer
A history of diabetes for more than 10 years and poorly controlled blood glucose levels
Patients who cannot tolerate chemoradiotherapy due to severe cardiac, lung, liver or kidney dysfunction, or hematopoietic disease or cachexia
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
A history of interstitial lung disease or non-infectious pneumonia
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
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)
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