NCT07469241

Study of MRI Guided Personal Chemoradiotherapy and Immunotherapy for Limited Advanced Esophageal Squamous Caicinoma.

MRI Guided Personal Chemoradiotherapy and Immunotherapy for Limited Advanced Esophageal Squamous Caicinoma: A Prospective, Multicenter, Single Arm, Phase II Study (FUTURE-3)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

FUTURE-3 was a prospective, multicenter, single-arm phase II study designed to explore the efficacy and safety of MRI-guided individualized chemoradiotherapy for locally advanced esophageal squamous cell carcinoma. The primary endpoint was one-year progression-free survival rate.

Detailed description

In this study, patients will receive two cycles of TPF chemotherapy plus adeberib immunotherapy induction, followed by concurrent chemoradiotherapy. One month after the completion of radiotherapy, adebrelimab immunotherapy will be initiated for two years for maintenance. Based on the results of enhanced MRI, the regimen will be adjusted three times: ① After one chemoradiotherapy induction cycle, if the tumor shrinkage is \<20%, the TPF regimen will be replaced with the FLOT regimen; ② After the completion of radiotherapy, if MRI shows significant residual tumor, CRP \<10 ng/L, and no grade II or higher adverse reactions, maintenance immunotherapy will be initiated immediately; ③ One month after radiotherapy, if MRI shows significant residual tumor, capecitabine metrotherapy will be added, and the radiotherapy dose for residual lesions will be increased.

Conditions

• Advanced Esophageal Squamous Cell Carcinoma
• Unresectable Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Concurrent chemoradiotherapy (cCRT)	concurrent chemoradiotherapy
DRUG	Induced treatment	TPF (Paclitaxel micelles or albumin-bound paclitaxel 100 mg/m2, cisplatin 30 mg/m2, fluorouracil 200 mg/m2 IV drip + 1000 mg/m2 pump for 44 hours, leucovorin/calcium 200 mg) + Adebrelimab 1200mg

Timeline

• Start date: 2026-03-10
• Primary completion: 2028-12-31
• Completion: 2029-06-30
• First posted: 2026-03-13
• Last updated: 2026-03-13