Who is sponsoring NCT03914443?

NCT03914443 is sponsored by National Cancer Center, Japan.

What drugs are being tested in NCT03914443?

Interventions in NCT03914443: Nivolumab, 5-FU, CDDP, DTX.

What condition does NCT03914443 study?

NCT03914443 studies Locally Advanced Esophageal Squamous Cell Carcinoma.

Is NCT03914443 still recruiting?

NCT03914443 is currently completed. Last updated 31 May 2025.

Last reviewed 2025-05-31 · How we verify

NCT03914443

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Feasibility Trial of Nivolumab With Neoadjuvant CF or DCF Therapy for Locally Advanced Esophageal Carcinoma

Completed Phase 1 Last updated 31 May 2025

What this trial tests

Phase 1 trial testing Nivolumab in Locally Advanced Esophageal Squamous Cell Carcinoma in 37 participants. Completed in 31 March 2025.

Timeline

7 May 2019

Primary endpoint
31 March 2025

31 March 2025

Quick facts

Lead sponsor	National Cancer Center, Japan
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	37
Start date	7 May 2019
Primary completion	31 March 2025
Estimated completion	31 March 2025
Sites	1 location across Japan

Drugs / interventions tested

Nivolumab (nivolumab) — full drug profile →
5-FU (5-fu) — full drug profile →
CDDP — full drug profile →
DTX — full drug profile →

Conditions studied

Locally Advanced Esophageal Squamous Cell Carcinoma — all drugs for Locally Advanced Esophageal Squamous Cell Carcinoma →

Sponsor

National Cancer Center, Japan

Who can join

Adults 20 to 75, any sex, with Locally Advanced Esophageal Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The main purpose of this study is to evaluate the safety of the neoadjuvant therapy, nivolumab with CF (5-FU, CDDP) or nivolumab with DCF (5-FU, CDDP, DTX), for locally advanced esophageal carcinoma.

Publications & conference data

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

Feasibility study of nivolumab as neoadjuvant chemotherapy for locally esophageal carcinoma: FRONTiER (JCOG1804E).
Yamamoto S, Kato K, Daiko H, Kojima T, et al · · 2020 · cited 56× · PMID 32396014 · DOI 10.2217/fon-2020-0189
Transcriptomic datasets of cancer patients treated with immune-checkpoint inhibitors: a systematic review.
Kovács SA, Győrffy B. · · 2022 · cited 45× · PMID 35641998 · DOI 10.1186/s12967-022-03409-4
Neoadjuvant immunotherapy for resectable esophageal cancer: A review.
Li Q, Liu T, Ding Z. · · 2022 · cited 43× · PMID 36569908 · DOI 10.3389/fimmu.2022.1051841
Combining serum inflammation indexes at baseline and post treatment could predict pathological efficacy to anti‑PD‑1 combined with neoadjuvant chemotherapy in esophageal squamous cell carcinoma.
Zhang X, Gari A, Li M, Chen J, et al · · 2022 · cited 40× · PMID 35109887 · DOI 10.1186/s12967-022-03252-7
Recent Advances in Combination of Immunotherapy and Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma.
Wang R, Liu S, Chen B, Xi M. · · 2022 · cited 35× · PMID 36291954 · DOI 10.3390/cancers14205168
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
Immunotherapy for Esophageal Cancer: State-of-the Art in 2021.
Teixeira Farinha H, Digklia A, Schizas D, Demartines N, et al · · 2022 · cited 33× · PMID 35158822 · DOI 10.3390/cancers14030554

Verify or expand the search:

Other trials of Nivolumab

Trials testing the same drug.

NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem · Phase 2, PHASE3 · not yet recruiting
NCT07444619 — A Phase I Study of Pazopanib in Combination With Trabectedin, Ipilimumab and Nivolumab (TraPIN) in Pediatric and Young A · Phase 1 · not yet recruiting
NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer · Phase 3 · not yet recruiting
NCT07420439 — Treatment in Patients With Advanced Non-Small Cell Lung Carcinoma and Interstitial Lung Disease · Phase 2 · not yet recruiting
NCT07510334 — VSV-IFNβ-NIS With Ipilimumab and Nivolumab for the Treatment of Advanced or Metastatic Clear Cell Renal Cell Carcinoma · Phase 2 · not yet recruiting

Other recruiting trials for Locally Advanced Esophageal Squamous Cell Carcinoma

Currently open trials in the same condition.

NCT06356688 — A Clinical Study on the Efficacy and Safety of Paclitaxel Polymeric Micelles and Cisplatin Combined With Cadonilimab as · Phase 2 · recruiting
NCT06843889 — A Phase II Study of Toripalimab Combined With Sequential Neoadjuvant Chemoradiotherapy in Patients With Esophageal Squam · Phase 2 · recruiting
NCT06342167 — Efficacy and Safety of Concurrent PD-1 Inhibitor and Radiotherapy With Immunonutrition for Esophageal Squamous Cell Carc · Phase 2 · active not recruiting
NCT06187597 — Consolidation of Toripalimab After Chemoradiotherapy in Elderly Esophageal Cancer (EC-CRT-007) · Phase 2 · recruiting
NCT06907602 — Optimizing Neoadjuvant Treatment Regimens for Locally Advanced Esophageal Squamous Cell Carcinoma · Phase 2, PHASE3 · recruiting

Other National Cancer Center, Japan trials

Trials by the same sponsor.

NCT07347314 — Enfortumab Vedotin in Patients With Advanced Small Bowel Adenocarcinoma Refractory or Intolerant to Platinum-based Combi · Phase 2 · recruiting
NCT06854939 — A Prospective Study Investigating the Relationship Between Minimal Residual Disease Detection, Monitoring Frequency, and · not yet recruiting
NCT06673628 — Pembrolizumab Plus Lenvatinib in Unresectable Cutaneous Angiosarcoma Patients · Phase 2 · recruiting
NCT05832827 — First-line CBDCA/PTX/LEN/Pembrolizumab Combination for Previously Untreated Advanced or Recurrent Thymic Carcinomas (Art · Phase 2 · recruiting
NCT06159478 — Binimetinib in Patients With BRAF Fusion-positive Low-grade Glioma or Pancreatic Cancer (Perfume) · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03914443 (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 National Cancer Center, Japan
Last refreshed: 31 May 2025

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/NCT03914443.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing