Definitive CCRT Combined With Durvalumab and Tremelimumab for Inoperable Esophageal Cancer

Samsung Medical Center40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

DurvalumabDRUG

concurrent radiotherapy

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Samsung Medical Center

Seoul, MA, South Korea

Outcomes

Primary Outcomes

Progression-free survival

Time interval from enrollment to disease progression or death

Time frame: 1 year

Data from ClinicalTrials.gov

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