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A single-center, single-arm exploratory study based on AI imaging to evaluate the efficacy of toripalimab combined with albumin-paclitaxel and nedaplatin neoadjuvant therapy for esophageal cancer

A single-center, single-arm exploratory study based on AI imaging to evaluate the efficacy of toripalimab combined with albumin-paclitaxel and nedaplatin neoadjuvant therapy for esophageal cancer

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106521
Enrollment
Unknown
Registered
2025-07-24
Start date
2025-07-28
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal cancer

Interventions

Neoadjuvant Therapy Group for Esophageal Cancer:Toripalimab 240 mg administered via intravenous infusion every three weeks. Albumin-bound paclitaxel 260 mg/m2 administered via intravenous infusion onc

Sponsors

Gansu Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: - Age between 18 and 75 years, regardless of gender. - Histologically confirmed locally advanced esophageal squamous cell carcinoma (Stage II–III). - ECOG performance status score of 0 or 1. - Planned surgical intervention following neoadjuvant therapy. - The baseline and post-treatment CT image data were of sufficient quality for evaluation.

Exclusion criteria

Exclusion criteria: - Presence of concomitant malignant tumors or severe comorbidities. - Prior receipt of immunotherapy or neoadjuvant treatment. - Incomplete or unsuitable imaging data for omics analysis.

Design outcomes

Primary

MeasureTime frame
Develop an artificial intelligence model based on radiomics to predict the pathological complete response (pCR) rate following neoadjuvant therapy.;

Secondary

MeasureTime frame
The Predictive Value of Radiomic Features in Assessing Tumor Downstaging;The Association Between Radiomic Features and Long-Term Survival Outcomes (Overall Survival and Progression-Free Survival) in Patients;The Predictive Value of Imaging Features in Assessing Treatment-Related Adverse Reactions;

Countries

China

Contacts

Public ContactYunjiu Gou

Gansu Provincial People's Hospital

gouyunjiu@163.com+86 139 1912 7670

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026