Chemoradiotherapy Plus Immunotherapy Followed by Surgery for Esophageal Cancer (CRISEC)

Huazhong University of Science and Technology

Status and phase: Active, not recruiting; Phase 2

Conditions: Esophagus Cancer; Neoadjuvant Therapy

Treatments: Drug: Tislelizumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04776590

ESC001

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Tislelizumab arm

Experimental group

Description:

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)

Treatment:

Drug: Tislelizumab