Overview

Combination of Toripalimab and Chemoradiotherapy in Esophageal Cancer

Status:
Active, not recruiting
Trial end date:
2021-12-31
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mian XI
Treatments:
Albumin-Bound Paclitaxel
Cisplatin
Paclitaxel
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).