Status:
UNKNOWN
Neoadjuvant Chemoradiotherapy Combined With Perioperative Toripalimab in Locally Advanced Esophageal Cancer
Lead Sponsor:
RenJi Hospital
Conditions:
Advanced Esophageal Squamous Cell Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 a...
Eligibility Criteria
Inclusion
- 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) ≥ 3.0×109/L；b. neutrophil count (ANC) ≥ 1.5×109/L; c. platelets ≥ 85×109/L; d. hemoglobin ≥ 9g/dL; e. total bilirubin ≤ 14.4µmol/L; f. ALT ≤ 75U/L; g. serum creatinine ≤ 104µmol/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
- 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 immunodeficiency，including 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.
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04437212
Start Date
July 1 2020
End Date
December 31 2023
Last Update
June 26 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Renji Hospital
Shanghai, Shanghai Municipality, China, 200127