Combination of Toripalimab and Neoadjuvant Chemoradiotherapy in Esophageal Cancer

Last updated: December 22, 2019
Sponsor: Jianhua Fu
Overall Status: Active - Recruiting

Phase

2

Condition

Lung Cancer

Esophageal Disorders

Squamous Cell Carcinoma

Treatment

N/A

Clinical Study ID

NCT04006041
TORINEOEC
  • Ages 18-70
  • All Genders

Study Summary

Neoadjuvant chemoradiotherapy (CRT) followed by surgery has become the standard treatment option for locally advanced esophageal cancer (EC). However, only 20% to 40% of EC patients can achieve pathologic complete response (pCR) after neoadjuvant CRT with favorable prognosis. 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 neoadjuvant CRT in locally advanced esophageal squamous cell carcinoma (ESCC).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. A histopathological diagnosis of resectable thoracic esophageal squamous cellcarcinoma with a pre-treatment clinical stage of T1-4aN1-3M0 or T3-4aN0M0 according tothe 8th edition of the UICC staging system;

  2. Patients who are anti-tumor treatment-naive;

  3. Estimated life expectancy >6 months

  4. Aged 18 to 70 years old of either gender

  5. The function of important organs meets the following requirements: a. white blood cellcount (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 creatinineclearance rate >60 mL/min;

  6. PS score of 0-1;

  7. Ability to understand the study and sign informed consent.

Exclusion

Exclusion Criteria:

  1. Patients who have been treated previously with anti-tumor therapy (includingchemotherapy, radiotherapy, surgery, immunotherapy, etc.);

  2. Known or suspected allergy or hypersensitivity to monoclonal antibodies, anyingredients of Toripalimab, and the chemotherapeutic drugs paclitaxel or cisplatin;

  3. Patients who have a preexisting or coexisting bleeding disorder;

  4. Other uncontrollable inoperable patients;

  5. Female patients who are pregnant or lactating;

  6. Inability to provide informed consent due to psychological, familial, social and otherfactors;

  7. Presence of CTC grade ≥ 3 peripheral neuropathy;

  8. A history of malignancies other than esophageal cancer before enrollment, excludingnon-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 glucoselevels;

  10. Patients who cannot tolerate chemoradiotherapy or surgery 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 notlimited to these diseases or syndromes, such as colitis, hepatitis, hyperthyroidism),a history of immunodeficiency (including a positive HIV test result), or otheracquired or congenital immunodeficiency diseases, a history of organ transplantationor 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 ofactive pulmonary tuberculosis infection more than 1 year ago but without formalanti-tuberculosis treatment;

  14. Presence of active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL), hepatitis C (positive for hepatitis C antibody, and HCV-RNA levels higher than the lower limit ofthe assay).

Study Design

Total Participants: 44
Study Start date:
June 25, 2019
Estimated Completion Date:
December 31, 2020

Connect with a study center

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong 510060
    China

    Active - Recruiting

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