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NCT03377400

Definitive CCRT Combined With Durvalumab and Tremelimumab for Inoperable Esophageal Cancer

Status unknown Phase 2 Last updated 17 December 2020
What this trial tests

Phase 2 trial testing Durvalumab in Esophageal Squamous Cell Carcinoma in 40 participants. Status unknown.

Timeline
14 December 2017
Primary endpoint
30 June 2021
30 December 2021

Quick facts

Lead sponsorSamsung Medical Center
PhasePhase 2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment40
Start date14 December 2017
Primary completion30 June 2021
Estimated completion30 December 2021
Sites1 location across South Korea

Drugs / interventions tested

Conditions studied

Sponsor

Samsung Medical Center

Who can join

19 and older, any sex, with Esophageal Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Characterization of cancer genomic heterogeneity by next-generation sequencing advances precision medicine in cancer treatment.
    Zhang J, Späth SS, Marjani SL, Zhang W, et al · · 2018 · cited 90× · PMID 30687561 · DOI 10.1093/pcmedi/pby007
  2. Enhance the Immune Checkpoint Inhibitors Efficacy with Radiotherapy Induced Immunogenic Cell Death: A Comprehensive Review and Latest Developments.
    Procureur A, Simonaggio A, Bibault JE, Oudard S, et al · · 2021 · cited 49× · PMID 33567530 · DOI 10.3390/cancers13040678
  3. The Combination Options and Predictive Biomarkers of PD-1/PD-L1 Inhibitors in Esophageal Cancer.
    Yang H, Wang K, Wang T, Li M, et al · · 2020 · cited 35× · PMID 32195194 · DOI 10.3389/fonc.2020.00300
  4. Immune evasion in esophageal squamous cell cancer: From the perspective of tumor microenvironment.
    Li R, Huang B, Tian H, Sun Z. · · 2022 · cited 33× · PMID 36698392 · DOI 10.3389/fonc.2022.1096717
  5. Immune Checkpoints Pathways in Head and Neck Squamous Cell Carcinoma.
    Veigas F, Mahmoud YD, Merlo J, Rinflerch A, et al · · 2021 · cited 30× · PMID 33804419 · DOI 10.3390/cancers13051018
  6. Immune checkpoint inhibitors for esophageal squamous cell carcinoma: a narrative review.
    Zhang W, Wang P, Pang Q. · · 2020 · cited 29× · PMID 33241042 · DOI 10.21037/atm-20-4625
  7. Current status and perspectives of esophageal cancer: a comprehensive review.
    Jiang W, Zhang B, Xu J, Xue L, et al · · 2025 · cited 28× · PMID 39723635 · DOI 10.1002/cac2.12645
  8. Immune checkpoint inhibitors in esophageal squamous cell carcinoma: progress and opportunities.
    Jiao R, Luo H, Xu W, Ge H. · · 2019 · cited 26× · PMID 31551657 · DOI 10.2147/ott.s214579

Verify or expand the search:

Other trials of Durvalumab

Trials testing the same drug.

Other recruiting trials for Esophageal Squamous Cell Carcinoma

Currently open trials in the same condition.

Other Samsung Medical Center trials

Trials by the same sponsor.

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Data sources for this page

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