Chemoradiotherapy Plus Immunotherapy Followed by Surgery for Esophageal Cancer

NCT ID: NCT04776590

Last Updated: 2024-04-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-28
• Study Completion Date: 2024-12-15

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.

Conditions

Esophagus Cancer; Neoadjuvant Therapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Tislelizumab

Intervention Type: DRUG

neoadjuvant immunotherapy

Interventions

Tislelizumab

neoadjuvant immunotherapy

Intervention Type: DRUG

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；
• KPS≥70
• Adequate organ function

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BeiGene

INDUSTRY

Sponsor Role: collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

kunyu yang

Director of Department of Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kunyu Yang, MD

Role: PRINCIPAL_INVESTIGATOR

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Locations

Union Hospital

Wuhan, Hubei, China

Countries

China

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Other Identifiers

ESC001

Identifier Type: -

Identifier Source: org_study_id