Last reviewed · How we verify

NCT05103501: SINCERE

Salvage Immunotherapy and Chemotherapy in Esophageal Squamous Cell Carcinoma Patients Nonresponding to Initial Neoadjuvant Chemoradiotherapy

Status unknown Phase 2 Last updated 2 November 2021
What this trial tests

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.

Timeline
1 December 2021
Primary endpoint
30 September 2023
30 September 2024

Quick facts

Lead sponsorShanghai Chest Hospital
PhasePhase 2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment54
Start date1 December 2021
Primary completion30 September 2023
Estimated completion30 September 2024

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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:

Other Shanghai Chest Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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