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NCT03377400
Definitive CCRT Combined With Durvalumab and Tremelimumab for Inoperable Esophageal Cancer
Phase 2 trial testing Durvalumab in Esophageal Squamous Cell Carcinoma in 40 participants. Status unknown.
30 June 2021
Quick facts
| Lead sponsor | Samsung Medical Center |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 14 December 2017 |
| Primary completion | 30 June 2021 |
| Estimated completion | 30 December 2021 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- Durvalumab — full drug profile →
Conditions studied
- Esophageal Squamous Cell Carcinoma — all drugs for Esophageal Squamous Cell Carcinoma →
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):
-
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT03377400
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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- NCT07409441 — Korea Acute Myocardial Infarction Registry · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03377400 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Samsung Medical Center
- Last refreshed: 17 December 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03377400.
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