Low-Dose Radiotherapy With Retlirafusp Alfa and Chemotherapy as Neoadjuvant Therapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma
NCT07682376 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96
Last updated 2026-07-02
Summary
This study aims to evaluate the efficacy and safety of neoadjuvant low-dose radiotherapy combined with Retlirafusp alfa and chemotherapy in the treatment of resectable locally advanced esophageal squamous cell carcinoma.
Conditions
- Esophageal Squamous Cell Carcinoma (ESCC)
Interventions
- DRUG
-
Low-dose radiotherapy + Retlirafusp alfa + nab-paclitaxel + cisplatin/carboplatin
Low-dose radiotherapy: 8 Gy in 4 fractions, 2 Gy per fraction, targeting the primary tumor and metastatic lymph nodes. Retlirafusp alfa: 1800 mg or 30 mg/kg on D1, q3w, for 2 cycles. Nab-paclitaxel: 125 mg/m² on D1 and D8, plus cisplatin 75 mg/m² on D1 or carboplatin AUC=5 on D1, q3w, for 2 cycles.
- DRUG
-
Retlirafusp alfa + nab-paclitaxel + cisplatin/carboplatin
Retlirafusp alfa: 1800 mg or 30 mg/kg on D1, q3w, for 2 cycles. Nab-paclitaxel: 125 mg/m² on D1 and D8, plus cisplatin 75 mg/m² on D1 or carboplatin AUC=5 on D1, q3w, for 2 cycles.
Sponsors & Collaborators
-
Henan Cancer Hospital
collaborator OTHER_GOV -
Shanxi Province Cancer Hospital
collaborator OTHER -
Peking Union Medical College Hospital
collaborator OTHER -
Harbin Medical University
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-10
- Primary Completion
- 2028-05-30
- Completion
- 2029-05-30
Countries
- China
Study Locations
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