ClinicalTrials.gg
Status unknownNCT03377400Updated Dec 17, 2020

Definitive CCRT Combined With Durvalumab and Tremelimumab for Inoperable Esophageal Cancer

A Phase 2 interventional study of Durvalumab in Esophageal Squamous Cell Carcinoma, sponsored by Samsung Medical Center. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2020-12-17.

Sponsored by Samsung Medical Center · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2020), so the status shown — last known as Active, not recruiting — may be out of date.

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Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
19 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 44 studies in Esophageal Squamous Cell Carcinoma with a site in Korea, Republic of — 9 open to participants now, 11 under way, 2 of them phase 3. Esophageal Squamous Cell Carcinoma · Korea, Republic of.

Planned enrollment
36th of 43
40 · median 138
Started
2017
with 2 others
Phase 2
17 of 44
1 open now
Registered
14th of 44
by date
Lead sponsor
7 of 44
Samsung Medical Center

Among the 44 studies in Esophageal Squamous Cell Carcinoma with a site in Korea, Republic of, this one is the 36th largest by planned enrollment of the 43 interventional ones that give a count, is one of 3 that started in 2017, is one of 17 in phase 2, and was the 14th registered.

Esophageal Squamous Cell Carcinoma

676 studies on the registry are indexed under Esophageal Squamous Cell Carcinoma; 267 are open to participants now.

Browse Esophageal Squamous Cell Carcinoma studies →

Open to participants now

9 of the 44 studies in Esophageal Squamous Cell Carcinoma with a site in Korea, Republic of are open now. Recruiting first, the newest first:

4 more — sign in →

All 9 open studies →

A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →

Who these studies take

Of the 180 Esophageal Squamous Cell Carcinoma studies recruiting now, 83 (46%) set no upper age limit and 76 (42%) stop at 75 or younger; 3 take children under 18; 8 take healthy volunteers.

This study: 19 Years and older · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 44 studies in Esophageal Squamous Cell Carcinoma with a site in Korea, Republic of, or all of them as a file.
02

Study summary

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.

03

Conditions studied

  • Esophageal Squamous Cell Carcinoma
04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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
  • PS of 0 to 1

Exclusion criteria

Exclusion Criteria:

  • clinical T4 disease (for example, invasion to aorta, vertebral body, or trachea/bronchus) or distant (M1)
  • previously received radiotherapy for esophageal cancer
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    study arm

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

    Drug: Durvalumab

Interventions

  • concurrent radiotherapy

    Also known as: tremelimumab, 5FU, Cisplatin

This study also gives Tremelimumab. No intervention listed here names it: that was found by reading the record.

06

What researchers measure

Primary outcomes

  1. Progression-free survival

    Time interval from enrollment to disease progression or death

    Time frame: 1 year

07

Study locations

1 site
  • Samsung Medical Center
    Seoul, MA 06351, Korea, Republic of
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2017 (actual). Primary completion is estimated for Jun 2021, 42 months after the start.

Of 153 non-industry phase 2 interventional studies under Esophageal Squamous Cell Carcinoma, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 55. This study's planned 42 months is close to that.

Counting every sponsor, half of 173 studies reached it within 40 months; a quarter within 28 and three quarters within 52.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 14, 2017
First posted
Dec 19, 2017
StartActual
Dec 14, 2017
Primary completionEst.
Jun 30, 2021
CompletionEst.
Dec 30, 2021
Last update
Dec 17, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03377400
Responsible party
Jong-Mu Sun (Associated Professor, Samsung Medical Center) — Principal investigator
First posted
Dec 19, 2017
Start date
Dec 14, 2017
Primary completion
Jun 30, 2021 (estimated)
Completion
Dec 30, 2021 (estimated)
Last update
Dec 17, 2020

Study contacts

Jong-Mu Sun, MD
principal investigator · Samsung Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Tremelimumab

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