Esophageal Squamous Cell Carcinoma
Conditions
Brief summary
This study is aimed to evaluate the efficacy and safety of short-course radiotherapy combined with sintilimab in neoadjuvant treatment of stage III, locally advanced esophageal squamous cell carcinoma.
Detailed description
This study was designed as a single arm, phase II trial. Subjects will receive short-course radiotherapy combined with sintilimab as neoadjuvant therapy of stage III, locally advanced esophageal squamous cell carcinoma. The primary endpoint is pathologic complete response(pCR).
Interventions
DRUGsintilimab，programmed death 1 monoclonal antibody
short-course radiotherapy +sintilimab (200mg, iv, D1, Q3W)
Sponsors
Fujian Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 18 years old and ≤75 years old * Esophageal squamous cell carcinoma diagnosed biopsy histopathology * Patients with resectable esophageal squamous cell carcinoma confirmed by pathology (including histology or cytology) , with pathological stage T3-4 or N+ * At least one measurable lesion * Eastern cooperative oncology group (ECOG) performance status of 0 to 1 * With adequate organs function
Exclusion criteria
* Patients with active malignancy within 5 years other than the tumor studied in this study or a localized tumor that has been cured such as resected basal or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or breast cancer * Patients who have a higher risk of bleeding or perforation due to the tumor's obvious invasion of the adjacent organs (aorta or trachea) of the esophageal lesion, or patients who have formed a fistula * Patients who have received any anti-tumor therapy for the research disease in the past, including radiotherapy, chemotherapy, immunotherapy (including but not limited to interleukin, interferon, thymus hormone) and traditional Chinese medicine therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate of adverse events | 3 years | The ratio of the number of cases with adverse events to the total number of cases available for evaluation. |
| Pathological complete response | 4 weeks after surgery | Total tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | 3 years | the time from randomization to death |
| Disease-free survival | 3 years | the time from treatment until the recurrence of disease (or death) after undergoing curative-intent treatment |
Contacts
Primary ContactJiancheng Li
Outcome results
None listed