Last reviewed · How we verify
NCT04054518: DESC
Durvalumab as Maintenance Following Chemoradiation for Unresectable Esophageal Squamous Cell Carcinoma
Phase 2 trial testing Durvalumab in Esophageal Squamous Cell Carcinoma in 22 participants. Status unknown.
1 October 2022
Quick facts
| Lead sponsor | Tiago Biachi |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 22 |
| Start date | 1 October 2019 |
| Primary completion | 1 October 2022 |
| Estimated completion | 1 October 2022 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- Durvalumab — full drug profile →
Conditions studied
- Esophageal Squamous Cell Carcinoma — all drugs for Esophageal Squamous Cell Carcinoma →
Sponsor
Tiago Biachi
Who can join
18 and older, any sex, with Esophageal Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Single arm phase II trial designed to assess the efficacy of durvalumab treatment in terms of 6-month progression-free survival. We will include 22 patients who will receive 1500 mg durvalumab (MEDI4736) via IV infusion Q4W \<\<for up to a maximum of 12 months (up to 13 doses/cycles) with the last administration on week 48\>\> or \<\<until confirmed disease progression\>\> unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met. If a patient's weight falls to 30 kg or below for 1 week or longer ( ≥ 7 days) durvalumab will be permanently discontinued.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
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 -
Radiotherapy combined with immune checkpoint inhibitors in locally advanced/metastatic esophageal squamous cell carcinoma: clinical trials, efficacy and future directions.
Jiang M, Hu Y, Lin G, Chen C, et al · · 2023 · cited 18× · PMID 37325652 · DOI 10.3389/fimmu.2023.1177085 -
Efficacy and safety of radiotherapy/chemoradiotherapy combined with immune checkpoint inhibitors for locally advanced stages of esophageal cancer: A systematic review and meta-analysis.
Wu J, Deng R, Ni T, Zhong Q, et al · · 2022 · cited 15× · PMID 35992797 · DOI 10.3389/fonc.2022.887525 -
Challenges and perspectives for immunotherapy in oesophageal cancer: A look to the future (Review).
Lampis A, Ratti M, Ghidini M, Mirchev MB, et al · · 2021 · cited 5× · PMID 33846775 · DOI 10.3892/ijmm.2021.4930 -
Mathematical Modeling Predicts Optimal Immune Checkpoint Inhibitor and Radiotherapy Combinations and Timing of Administration.
Sakai SA, Saeki K, Chi S, Hamaya Y, et al · · 2025 · cited 3× · PMID 39666379 · DOI 10.1158/2326-6066.cir-24-0610
Verify or expand the search:
- PubMed search for NCT04054518
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Esophageal Squamous Cell Carcinoma
Currently open trials in the same condition.
- NCT07503808 — A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types · Phase 1 · recruiting
- NCT07385001 — A Prospective, Multicenter, Phase Ib/II Trial of Ivonescimab (AK112) Combined With Albumin-Paclitaxel and Cisplatin as N · Phase 1, PHASE2 · recruiting
- NCT07217171 — A Study Evaluating the Safety, Efficacy, and Pharmacokinetics (PK) of EVOLVE104 in Participants With Advanced Urothelial · Phase 1 · recruiting
- NCT07109726 — A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations · Phase 1, PHASE2 · recruiting
- NCT07090499 — A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors · Phase 1 · 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 NCT04054518 (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 Tiago Biachi
- Last refreshed: 13 August 2019
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/NCT04054518.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing