Definitive CCRT Combined With Durvalumab and Tremelimumab for Inoperable Esophageal Cancer

Samsung Medical Center

Status and phase: Unknown; Phase 2

Conditions: Esophageal Squamous Cell Carcinoma

Treatments: Drug: Durvalumab

Study type: Interventional

Funder types: Other

Identifiers

NCT03377400

SMC 2017-06-138

Details and patient eligibility

About

This is a single arm phase II study, in which 2 cycles of chemotherapy (5FU/CDDP) and immunotherapy (durvalumab and tremelimumab) are administered every 3 weeks with concurrent radiotherapy for inoperable locally advanced esophageal squamous cell carcinoma. Four weeks after completion of CCRT combined with immunotherapy, 2 cycles of durvaluma and tremelimumab will be administered every 4 weeks and thereafter durvalumab monotherapy Q4W will be maintained until unacceptable toxicity or disease progression, or for maximum 2 years after enrollment.

Enrollment: 40 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed squamous esophageal cancer
• The clinical stage T2-3N0M0 or T1-3N1-3M0
• Inoperable case: it refers to medically inoperable status and/or patient's refusal to surgery and/or cervical location and/or locoregionally recurrent tumor after primary surgery
• ECOG PS of 0 to 1

Exclusion criteria

• clinical T4 disease (for example, invasion to aorta, vertebral body, or trachea/bronchus) or distant metastasis (M1)
• previously received radiotherapy for esophageal cancer

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

study arm

Experimental group

Description:

Concurrent radiotherapy with chemotherapy (5FU/CDDP) and immune checkpoint inhibitors (durvalumab/tremelimumab), and followed by consolidation immune checkpoint inhibitors

Treatment:

Drug: Durvalumab