Last reviewed · How we verify

NCT06843889

A Phase II Study of Toripalimab Combined With Sequential Neoadjuvant Chemoradiotherapy in Patients With Esophageal Squamous Cell Carcinoma

Recruiting now Phase 2 Last updated 16 April 2025
What this trial tests

Phase 2 trial testing Toripalimab (240mg day1, Q3W*3cycle) in Locally Advanced Esophageal Squamous Cell Carcinoma in 34 participants. Currently enrolling.

Timeline
3 April 2025
Primary endpoint
1 August 2027
1 August 2028

Quick facts

Lead sponsorNanfang Hospital, Southern Medical University
PhasePhase 2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment34
Start date3 April 2025
Primary completion1 August 2027
Estimated completion1 August 2028
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Nanfang Hospital, Southern Medical University

Who can join

Adults 18 to 75, any sex, with Locally Advanced Esophageal Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This was a single-center, open phase II clinical study. 34 patients with resectable local middle and advanced esophageal squamous cell carcinoma were treated with anti-PD-1 antibody combined with sequential chemoratherapy regimen: Phase I:Toripalimab (240mg day1, Q3W\*2cycle) + clinical routine chemotherapy regimen selected by the investigator; The second stage: Toripalimab (240mg day1, Q3W\*1cycle) + radiotherapy (intensity modulated radiotherapy, 40Gy/20F, 2Gy/F); Surgery was performed 4-6 weeks after completion, and subsequent treatment options were considered after surgery according to MDT discussion. According to the postoperative pathological results, the pathological complete response (pCR) and major response (MPR) were evaluated. The disease-free survival (DFS), overall survival (OS), 1 or 2 years survival rate and adverse reactions were recorded.

Publications & conference data

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

  1. Divergent immuno-landscapes: comparing the tumor microenvironment of Indian and Western HNSCC patients.
    Kumar Rai P, Choudhary B. · · 2026 · PMID 42111272 · DOI 10.3389/fcell.2026.1725978
  2. The safety and efficacy of neoadjuvant immunochemotherapy in locally advanced esophageal squamous cell carcinoma: a meta-analysis and systematic review.
    Shen Q, Liu H, Xue H, Yilixiati A, et al · · 2026 · PMID 41743735 · DOI 10.3389/fimmu.2026.1687326

Verify or expand the search:

Other trials of Toripalimab (240mg day1, Q3W*3cycle)

Trials testing the same drug.

Other recruiting trials for Locally Advanced Esophageal Squamous Cell Carcinoma

Currently open trials in the same condition.

Other Nanfang Hospital, Southern Medical University 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/NCT06843889.

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