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NCT05394740
Clinical Study of Regorafenib and Nivolumab Plus Chemotherapy
Phase 1, PHASE2 trial testing Regorafenib in Gastric Adenocarcinoma in 30 participants. Completed in 25 August 2025.
14 April 2024
Quick facts
| Lead sponsor | National Cancer Center Hospital East |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 6 June 2022 |
| Primary completion | 14 April 2024 |
| Estimated completion | 25 August 2025 |
| Sites | 1 location across Japan |
Drugs / interventions tested
- Regorafenib — full drug profile →
- Nivolumab (nivolumab) — full drug profile →
- CapeOX — full drug profile →
- FOLFOX regimen
Conditions studied
- Gastric Adenocarcinoma — all drugs for Gastric Adenocarcinoma →
- Gastroesophageal Junction Adenocarcinoma — all drugs for Gastroesophageal Junction Adenocarcinoma →
- Esophageal Adenocarcinoma — all drugs for Esophageal Adenocarcinoma →
Sponsor
National Cancer Center Hospital East
Who can join
20 and older, any sex, with Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is an open-label, single-arm, single-center Phase Ib/II study to exploratorily evaluate the tolerability, safety, and efficacy of regorafenib and nivolumab plus chemotherapy in patients with unresectable advanced/recurrent gastric/ gastroesophageal junction/esophageal adenocarcinoma.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Current state of the art: immunotherapy in esophageal cancer and gastroesophageal junction cancer.
Li N, Sohal D. · · 2023 · cited 22× · PMID 37995002 · DOI 10.1007/s00262-023-03566-5
Verify or expand the search:
- PubMed search for NCT05394740
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Regorafenib
Trials testing the same drug.
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- NCT07392866 — A Clinical Study of SH006 Injection in Combination Therapy Versus Regorafenib in the Treatment of Advanced Hepatocellula · Phase 2, PHASE3 · not yet recruiting
- NCT06820957 — Testing a New Combination of Anti-cancer Drugs in Patients Newly Diagnosed With Ewing Sarcoma Who Have Cancer That Has S · Phase 2, PHASE3 · active not recruiting
- NCT07223567 — A Trial of Regorafenib Plus Lorigerlimab in Patients With Locally Recurrent or Regrowing pMMR/MSS Localized Rectal Cance · Phase 2 · withdrawn
- NCT07134205 — The Study of JMT101 Combined With Irinotecan as a ≥3rd-Line Treatment in Metastatic Colorectal Cancer · Phase 3 · not yet recruiting
Other recruiting trials for Gastric Adenocarcinoma
Currently open trials in the same condition.
- NCT07277413 — A Study of IDE892 as Monotherapy and Combination in MTAP-deleted Advanced Solid Tumors · Phase 1 · recruiting
- NCT07522320 — Costs of Opportunistic Upper Gastrointestinal Endoscopy and the Economic Burden of Gastric Cancer Management · active not recruiting
- NCT07182149 — A Phase 1 Study of NRM-823 in Participants With Locally Advanced or Metastatic Refractory Solid Tumors · Phase 1 · recruiting
- NCT07001748 — Testing the Addition of Paclitaxel Administered Into the Abdominal Cavity Combined With Chemotherapy for Patients With G · Phase 2, PHASE3 · recruiting
- NCT07103668 — A Phase III Randomized Study in CLDN18.2-positive Unresectable Locally Advanced Gastric Cancer Patients · Phase 3 · recruiting
Other National Cancer Center Hospital East trials
Trials by the same sponsor.
- NCT07100704 — Recurrent/Metastatic Olfactory Neuroblastoma: Evaluating the Efficacy and Safety of Nivolumab · Phase 2 · recruiting
- NCT07529613 — Trastuzumab Deruxtecan Plus Nivolumab Plus Capecitabine Plus Oxaliplatin for HER2 Low Gastric and Gastroesophageal Junct · Phase 1, PHASE2 · completed
- NCT05646511 — TNT of SCRT+CAPOX vs SCRT+CAPOXIRI for Locally Advanced Rectal Cancer · Phase 3 · recruiting
- NCT05034887 — Phase 2 Study of Trastuzumab Deruxtecan in the Neoadjuvant Treatment, or Trastuzumab Deruxtecan Plus Capecitabine Plus D · Phase 2 · active not recruiting
- NCT04417192 — Olaparib Monotherapy and Olaparib + Pembrolizumab Combination Therapy for Ovarian Cancer · Phase 2 · completed
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 NCT05394740 (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 Hospital East
- Last refreshed: 9 April 2026
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/NCT05394740.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing