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Phase II Study of Induction Chemoimmunotherapy Followed by Radiotherapy and Organ Preservation in Resectable ESCC
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Summary
This multicenter, prospective Phase II study investigates a response-adapted organ-preservation strategy in patients with resectable esophageal squamous cell carcinoma (ESCC). Participants will receive two cycles of induction chemoimmunotherapy with sugemalimab, nab-paclitaxel, and cisplatin. Patients who achieve a major clinical response will receive definitive radiotherapy plus sugemalimab followed by maintenance sugemalimab, while non-major responders will undergo surgery-based treatment strategies. The study aims to evaluate the efficacy and safety of this tailored treatment approach, with the primary endpoint being 2-year progression-free survival. Secondary and exploratory objectives include survival outcomes, quality of life, nutritional status.
Official title: A Multicenter, Prospective Phase II Trial Evaluating Induction Chemotherapy Plus Sugemalimab Followed by Sequential Radiotherapy and Response-Guided Surgery or Organ Preservation in Resectable Esophageal Squamous Cell Carcinoma
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2026-07-01
Completion Date
2029-07-31
Last Updated
2026-07-17
Healthy Volunteers
No
Interventions
Sugemalimab and Chemotherapy
Sugemalimab 1200 mg administered intravenously every 3 weeks as induction, and maintenance immunotherapy.
Nab-paclitaxel
125 mg/m² administered intravenously on Days 1 and 8 every 3 weeks during induction therapy.
Cisplatin
75 mg/m² administered intravenously on Day 1 every 3 weeks during induction therapy.
Radiation Therapy
IMRT: PTV 41.4 Gy/23f，PGTV 49.45 Gy/23f
Locations (1)
National Cancer Center / Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China