Neoadjuvant Chemoradiotherapy Plus Tislelizumab Followed by Surgery for Thoracic Esophageal Squamous Cell Cancer: A Prospective, Single Arm, Pilot Study
Overview
- Phase
- Phase 2
- Intervention
- Tislelizumab
- Conditions
- Esophagus Cancer
- Sponsor
- Wuhan Union Hospital, China
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Pathologic complete response rate
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
Neoadjuvant chemoradiotherapy is recommended as standard therapy for resectable esophageal cancer. The recurrence rate after surgery following neoadjuvant chemoradiotherapy is about 35%. Whether achieving pathological complete response after neoadjuvant chemoradiotherapy is significantly associated with recurrence after surgery. It is reported that immunotherapy combined with chemotherapy improved survival compared with chemotherapy alone in first line therapy of advanced esophageal cancer. We hypothesize that the addition of immunotherapy to neoadjuvant chemoradiotherapy is helpful to improving pathologic complete response and survival.
Investigators
kunyu yang
Director of Department of Oncology
Wuhan Union Hospital, China
Eligibility Criteria
Inclusion Criteria
- •Pathologically diagnosed as esophageal squamous cell carcinoma
- •Initially diagnosed as thoracic esophageal cancer
- •resectable or potantially resectable
- •II-IVA according to AJCC 8th edition；
- •Adequate organ function
Exclusion Criteria
- Not provided
Arms & Interventions
Tislelizumab arm
Radiotherapy: PTV 41.4Gy in 23 Fractions，5 days per week; Chemotherapy: Paclitaxel (Albumin bound) (100mg per square meter of body-surface area weekly) and Caboplatin (area under the curve of 2 mg per milliliter per minute weekly) for 5 weeks, concurrent with radiotherapy; Immunotherapy: Tislelizumab (200mg per 3 weeks)
Intervention: Tislelizumab
Outcomes
Primary Outcomes
Pathologic complete response rate
Time Frame: 1 day on which pathologic results is reported
Pathologic complete response rate
Secondary Outcomes
- overall survival(2 years after enrollment)
- Disease free survival(2 years after surgery)