Chemoradiotherapy Plus Immunotherapy Followed by Surgery for Esophageal Cancer

Phase 2

Active, not recruiting

• Conditions: Neoadjuvant Therapy; Esophagus Cancer
• Interventions: Drug: Tislelizumab

• Registration Number: NCT04776590
• Lead Sponsor: Wuhan Union Hospital, China

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-28
• Study First Submitted: 2021-02-23
• Study First Submitted QC: 2021-02-26
• Study First Posted: 2021-03-01
• Primary Completion: 2023-03-11
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-12
• Study Completion: 2024-12-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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；
• KPS≥70
• Adequate organ function

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tislelizumab arm	Tislelizumab	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)

Primary Outcome Measures

Name	Time	Method
Pathologic complete response rate	1 day on which pathologic results is reported	Pathologic complete response rate

Secondary Outcome Measures

Name	Time	Method
Disease free survival	2 years after surgery	Disease free survival
overall survival	2 years after enrollment	overall survival

Trial Locations

Locations (1)

Union Hospital; 🇨🇳 Wuhan, Hubei, China