NCT07530094

Short-Course Definitive Chemoradiotherapy Combined With Adjuvant or Concurrent Plus Adjuvant Camrelizumab for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma

Short-Course Definitive Chemoradiotherapy Combined With Adjuvant or Concurrent Plus Adjuvant Camrelizumab for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma: A Prospective, Multicenter, Multi-Cohort Phase II Clinical Study (STELLAR01)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 98 (estimated)
• Sponsor: Ning Jiang, M.D./Ph.D. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study aims to compare the efficacy and safety of short-course definitive concurrent chemoradiotherapy plus immunotherapy followed by immunotherapy maintenance versus short-course definitive chemoradiotherapy plus immunotherapy maintenance in the treatment of locally advanced unresectable esophageal squamous cell carcinoma, and to exploratorily identify molecular biomarkers associated with treatment efficacy and toxicity.

Detailed description

The RTOG 8501 trial established definitive chemoradiotherapy (dCRT) as the standard treatment for patients with locally advanced unresectable esophageal cancer. Although long-term survival and even cure have been observed in a subset of patients treated with dCRT, the overall short- and long-term outcomes remain unsatisfactory. For example, the complete response (CR) rate after dCRT is only approximately 25%, most patients eventually experience local recurrence or distant metastasis, and the 5-year overall survival rate is only about 20%. Therefore, there remains a substantial unmet medical need for improving the treatment of patients with locally advanced unresectable esophageal cancer.In patients with unresectable esophageal cancer, several small-sample exploratory studies have investigated the combination of immunotherapy with dCRT. The EC-CRT-001 study preliminarily demonstrated that dCRT combined with toripalimab achieved a CR rate of 62% and a 1-year overall survival rate of 78.4% in patients with locally advanced unresectable esophageal squamous cell carcinoma. A study by Zhao et al. explored induction chemo-immunotherapy followed by concurrent chemoradiotherapy, reporting a 1-year overall survival rate of 88.0% and a 2-year local control rate of 81.7%, which were also superior to those reported in traditional studies of chemoradiotherapy alone. Taken together, these findings suggest that the incorporation of immune checkpoint inhibitors (ICIs) into definitive chemoradiotherapy-based multimodal treatment may improve outcomes in patients with locally advanced unresectable esophageal squamous cell carcinoma.Currently, several large randomized controlled trials, such as RATIONALE 311 and KUNLUN, are ongoing to evaluate the efficacy of immunotherapy maintenance following concurrent chemoradiotherapy compared with placebo. However, the optimal integration strategy of chemoradiotherapy and immunotherapy remains unclear. In lung cancer, the PACIFIC trial established the cornerstone role of immunotherapy maintenance in patients with unresectable stage III disease. In esophageal cancer, other studies such as SKYSCRAPER-07 are also investigating the efficacy and safety of immunotherapy maintenance following definitive chemoradiotherapy. Nevertheless, which combination strategy of conventional chemoradiotherapy and ICIs can best balance efficacy and toxicity remains to be elucidated and warrants further clinical investigation.Based on this background, the present study aims to investigate and compare the efficacy and safety of short-course definitive concurrent chemoradiotherapy plus immunotherapy followed by immunotherapy maintenance versus short-course definitive chemoradiotherapy plus immunotherapy maintenance in patients with locally advanced unresectable esophageal squamous cell carcinoma, and to exploratorily identify molecular biomarkers associated with treatment efficacy and toxicity.

Conditions

• Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Camrelizumab	This study aims to compare the efficacy and safety of two novel treatment strategies-short-course definitive chemoradiotherapy combined with adjuvant camrelizumab, and short-course definitive chemoradiotherapy combined with concurrent plus adjuvant camrelizumab-in patients with locally advanced unresectable esophageal squamous cell carcinoma.

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2026-04-15
• Last updated: 2026-04-15

Locations

1 site across 1 country: China