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Definitive CCRT Combined With Durvalumab and Tremelimumab for Inoperable Esophageal Cancer

NCT ID: NCT03377400

Last Updated: 2020-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-14

Study Completion Date

2021-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Esophageal Squamous Cell Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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study arm

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

Group Type EXPERIMENTAL

Durvalumab

Intervention Type DRUG

concurrent radiotherapy

Interventions

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Durvalumab

concurrent radiotherapy

Intervention Type DRUG

Other Intervention Names

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tremelimumab 5FU Cisplatin

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jong-Mu Sun

Associated Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jong-Mu Sun, MD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, MA, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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SMC 2017-06-138

Identifier Type: -

Identifier Source: org_study_id