Neoadjuvant Chemoradiotherapy Combined With Perioperative Toripalimab in Locally Advanced Esophageal Cancer

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    20
  • sponsor
    RenJi Hospital
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Updated on 25 January 2021
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Summary

Neoadjuvant chemoradiotherapy (CRT) followed by surgery has become the standard treatment option for locally advanced esophageal squamous cell cancer (ESCC). However, only 20% to 40% of patients can achieve pathologic complete response (pCR) after neoadjuvant CRT with favorable prognosis and about 10% of patients have disease progression after chemoradiotherapy. How to improve the the efficacy of neoadjuvant therapy is an important clinical problem to be solved.

Immunotherapy targeting the PD-1/PD-L1 checkpoints has demonstrated promising activity in advanced EC especially in ESCC. In Keynote181 study, for patients with metastatic esophageal squamous cell carcinoma, regardless of PD-L1 expression, pembrolizumab significantly improved overall survival compared with chemotherapy. However, the efficacy and safety of immunotherapy therapy in surgery-based multidisciplinary treatment of local advanced esophageal cancer still need a lot of clinical studies to further confirm.

The aim of this study was to evaluate the efficacy and safety of the neoadjuvant chemoradiotherapy combined with perioperative toripalimab in patients with locally advanced esophageal squamous cell cancer.

Details
Condition Advanced Esophageal Squamous Cell Cancer
Treatment Toripalimab, tpripalimab
Clinical Study IdentifierNCT04437212
SponsorRenJi Hospital
Last Modified on25 January 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Aged 18 to 75 years old of either gender
Patients with histopathological confirmed resectable thoracic esophageal squamous cell carcinoma who are anti-tumor treatment-naive
Clinical stage of T1-4aN1-2M0 or T3-4aN0M0 according to the 8th edition of the UICC staging system
ECOG PS score of 0-1
The indexes of hematology, biochemistry and organ function meet the following requirements: a. white blood cell count (WBC) 3.0109/Lb. neutrophil count (ANC) 1.5109/L; c. platelets 85109/L; d. hemoglobin 9g/dL; e. total bilirubin 14.4mol/L; f. ALT 75U/L; g. serum creatinine 104mol/L and creatinine clearance rate >60 mL/min
Women of childbearing age must undergo a pregnancy test within 7 days before enrolling in the treatment, and those who are negative can be enrolled. Patients of childbearing age and their sexual partners agree to use reliable methods of contraception before entering the study, during the study, and at least 180 days after the end of the study
Ability to understand the study and sign informed consent

Exclusion Criteria

Patients with active infection within 2 weeks before the first use of the study drug or need to be treated with oral or intravenous antibiotics
A history of interstitial lung disease or non-infectious pneumonia
Patients whose clinician judges surgery as the first choice for the best treatment
A history of autoimmune diseases or abnormal immune system
Patients who cannot tolerate chemoradiotherapy or surgery due to severe cardiac, lung dysfunction
Patients diagnosed with any other malignant tumor within 5 years before enrollment, except for malignant tumors with low risk of recurrence and risk of death, such as fully treated basal cell or squamous cell skin and carcinoma in situ of the cervix
Known or suspected allergy or hypersensitivity to monoclonal antibodies, any ingredients of Toripalimab, and the chemotherapeutic drugs paclitaxel or cisplatin
A history of immunodeficiencyincluding a positive HIV test result or other acquired or congenital immunodeficiency diseases, a history of organ transplantation or allogeneic bone marrow transplantation
Women during pregnancy or lactation
Other situations not suitable for enrollment
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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