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NCT05103501: SINCERE
Salvage Immunotherapy and Chemotherapy in Esophageal Squamous Cell Carcinoma Patients Nonresponding to Initial Neoadjuvant Chemoradiotherapy
Phase 2 trial testing PF regimen (cis-platinum ; 5-fluorouracil ) combined with PD-1 inhibitors(pembrolizumab) in Esophageal Squamous Cell Carcinomas in 54 participants. Status unknown.
30 September 2023
Quick facts
| Lead sponsor | Shanghai Chest Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 54 |
| Start date | 1 December 2021 |
| Primary completion | 30 September 2023 |
| Estimated completion | 30 September 2024 |
Drugs / interventions tested
- PF regimen (cis-platinum ; 5-fluorouracil ) combined with PD-1 inhibitors(pembrolizumab) — full drug profile →
Conditions studied
- Esophageal Squamous Cell Carcinomas — all drugs for Esophageal Squamous Cell Carcinomas →
Sponsor
Shanghai Chest Hospital
Who can join
Adults 18 to 75, any sex, with Esophageal Squamous Cell Carcinomas. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is an investigator-initiated, single-arm, exploratory clinical study.The study population consisted of esophageal squamous cell carcinoma patients nonresponding to initial neoadjuvant chemoradiotherapy. The purpose of this study was to evaluate the efficacy and safety of immunotherapy combined with chemotherapy in the adjuvant treatment of esophageal squamous cell carcinoma after surgery.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
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 -
Opportunities and challenges in combining immunotherapy and radiotherapy in esophageal cancer.
Zhang X, Cai X, Yan C. · · 2023 · cited 6× · PMID 37985502 · DOI 10.1007/s00432-023-05499-z
Verify or expand the search:
- PubMed search for NCT05103501
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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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 NCT05103501 (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 Shanghai Chest Hospital
- Last refreshed: 2 November 2021
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/NCT05103501.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing