Chemoradiotherapy Plus Immunotherapy Followed by Surgery for Esophageal Cancer

Phase 2Active Not RecruitingNCT04776590

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Esophagus Cancer Neoadjuvant Therapy

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Main 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

Outcomes

Primary Outcomes

Pathologic complete response rate

Time frame: 1 day on which pathologic results is reported

Secondary Outcomes

Disease free survival

Time frame: 2 years after surgery

overall survival

Time frame: 2 years after enrollment