Immunotherapy in Combination With Chemoradiotherapy in Unresectable Locally Advanced Esophageal Cancer
NCT06173986 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2023-12-18
Summary
SCR-ESCC-02 is a multicenter, phase I/II clinical study to investigate the safety and efficacy of induction immunochemotherapy followed by concurrent chemoradiotherapy with anti-PD-1 therapy in patients diagnosed with locally advanced, unresectable esophageal cancer.
Conditions
- Esophageal Squamous Cell Carcinoma
- Unresectable Locally Advanced Esophageal Cancer
Interventions
- DRUG
-
PD-1inhibitor
PD-1 inhibitor, Q3W, until disease progression or unacceptable toxicity or treatment reaches 1 year
- DRUG
-
nab-paclitaxel + cisplatin
Induction phase: nab-paclitaxel + cisplatin, Q3W × 2 cycles; Concurrent ICRT phase: nab-paclitaxel + cisplatin, QW × 5 cycles
- RADIATION
-
Radiotherapy
Primary tumor and metastatic lymph nodes, DT:45-50Gy/25fx, starting within 4 weeks following the completion of the last induction immunochemotherapy cycle
Sponsors & Collaborators
-
Shanghai Chest Hospital
lead OTHER
Principal Investigators
-
Wen Yu, M.D · Shanghai Chest Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-01-10
- Primary Completion
- 2025-12-30
- Completion
- 2027-12-30
Countries
- China
Study Locations
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