Short-course Radiotherapy Combined With Sintilimab for Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- sintilimab，programmed death 1 monoclonal antibody
- Conditions
- Esophageal Squamous Cell Carcinoma
- Sponsor
- Fujian Cancer Hospital
- Enrollment
- 30
- Primary Endpoint
- Pathological complete response
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
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).
Investigators
Eligibility Criteria
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
Arms & Interventions
short-course radiotherapy+sintilimab
Intervention: sintilimab，programmed death 1 monoclonal antibody
Outcomes
Primary Outcomes
Pathological complete response
Time Frame: 4 weeks after surgery
Total tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell
Incidence rate of adverse events
Time Frame: 3 years
The ratio of the number of cases with adverse events to the total number of cases available for evaluation.
Secondary Outcomes
- overall survival(3 years)
- Disease-free survival(3 years)