Neoadjuvant Therapy of Anlotinib Combined With Toripalimab and Chemotherapy for Resectable Esophageal Carcinoma
NCT05996484 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2023-08-21
Summary
The purpose of this study is to explore the effectiveness and safety of the combination of Anlotinib, Toripalimab, and albumin-bound paclitaxel with cisplatin for neoadjuvant therapy in resectable esophageal squamous cell carcinoma. The study aims to improve the pathological complete response rate (pCR), R0 resection rate, and disease-free survival (DFS) in patients undergoing esophageal cancer surgery. The findings of this study will provide guidance and new options for the treatment of locally advanced esophageal cancer patients.
Conditions
- Esophageal Carcinoma
- Neoadjuvant Therapy
Interventions
- DRUG
-
Toripalimab
Toripalimab, 240mg, IV., D1, every 3 weeks, 4 cycles.
- DRUG
-
Anlotinib hydrochloride
Anlotinib Hydrochloride is a capsule in the form of 8 mg ,10 mg and 12 mg, orally, once daily, 2 weeks on/1 week off, every 3 weeks, 4 cycles.
- DRUG
-
Albumin paclitaxel
Albumin paclitaxel, 200-260 mg/m2, IV., D1, every 3 weeks, 4 cycles.
- DRUG
-
Cisplatin, 60-75 mg/m2, IV., D1, every 3 weeks, 4 cycles.
Sponsors & Collaborators
-
Nanfang Hospital, Southern Medical University
lead OTHER
Principal Investigators
-
kaican cai, M.D., PhD · Nanfang Hospital, Southern Medical University
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
- 2023-09-30
- Primary Completion
- 2024-11-30
- Completion
- 2026-07-31
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