NCT07015489

Concurrent Radiotherapy Following Induction Chemoimmunotherapy for Locally Advanced Esophageal Cancer

A Prospective, Single-center Phase II Clinical Study of Concurrent Radiotherapy Following Induction Chemoimmunotherapy for Locally Advanced Esophageal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Esophageal cancer is one of the most common malignancies, and concurrent chemoradiotherapy (CRT) is the standard treatment for unresectable, locally advanced esophageal squamous cell carcinoma. In recent years, studies have suggested that combining immunotherapy with definitive CRT may further improve treatment outcomes. Currently, several clinical trials are underway to evaluate the efficacy of immunotherapy combined with chemotherapy (chemo) and radiotherapy in patients with unresectable, locally advanced esophageal cancer. The investigators plan to conduct a single-arm, prospective, single-center phase II clinical study to investigate the efficacy and safety of induction chemo and immunotherapy followed by concurrent radiotherapy (RT) in the treatment of locally advanced esophageal cancer. A total of 44 patients will be enrolled.

Conditions

• ESCC

Interventions

Type	Name	Description
DRUG	induction chemotherapy and immunotherapy	All patients will first receive 2 cycles of induction chemoimmunotherapy, followed by radiotherapy. During radiotherapy, 2 concurrent cycles of chemoimmunotherapy will be administered. Afterward, maintenance immunotherapy will continue for up to one year. Chemotherapy regimen: Paclitaxel: 135 mg/m², Day 1, every 3 weeks (Q3W); Carboplatin: area under the curve (AUC) = 5, intravenous infusion over more than 30 minutes, Day 2, Q3W; Alternatively, Nedaplatin: 75 mg/m², Day 2, Q3W. Immunotherapy regimen: programmed death-1 (PD-1) inhibitor (e.g., Camrelizumab): Day 0, intravenous infusion, Q3W; Continued until disease progression (PD) or unacceptable toxicity, for a maximum duration of one year. Radiotherapy: Prescribed dose: 95% of the planning target volume (PTV) and planning target volume for nodal disease (PTV-nd) should receive 50-50.4 Gy over 25-28 fractions; Fraction dose range: 1.8-2.0 Gy per fraction, 5 days per week; External beam radiotherapy to the chest.

Timeline

• Start date: 2022-01-01
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2025-06-11
• Last updated: 2025-06-11

Locations

1 site across 1 country: China