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.
Both anti-angiogenic therapy and immune checkpoint inhibitors have shown preliminary efficacy and safety data in the field of neoadjuvant therapy for esophageal cancer. However, there is currently no available data on the combination of immune checkpoint inhibitors, anti-angiogenic therapy, and chemotherapy in neoadjuvant therapy for esophageal cancer. Based on the favorable survival benefits of this combination in first-line and second-line treatments for multiple tumors, we aim to explore another neoadjuvant treatment approach - adding anti-angiogenic agents to immune checkpoint inhibitor-based neoadjuvant therapy, providing a new perioperative treatment strategy for esophageal cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Toripalimab, 240mg, IV., D1, every 3 weeks, 4 cycles.
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.
Albumin paclitaxel, 200-260 mg/m2, IV., D1, every 3 weeks, 4 cycles.
Cisplatin, 60-75 mg/m2, IV., D1, every 3 weeks, 4 cycles.
Pathologic complete remission (PCR)
Primary tumor or lymph node surgery specimen pathological examination without residual tumor cell
Time frame: Immediately after the surgery
R0 resection rate
Residual tumor rate
Time frame: Immediately after the surgery
Objective response rate (ORR)
ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Time frame: Up to 36 month
Disease control rate (DCR)
DCR is defined as the percentage of participants in the analysis population who have a CR, PR or stable disease (SD) per RECIST 1.1.
Time frame: Up to 36 month
Disease-free survival (DFS)
Survival without local or systemic recurrence
Time frame: 3(5) years after last patient enrolled
Overall survival (OS)
Overall survival is defined as the duration from date of enrollment to the date of death from any cause.
Time frame: Up to 36 month
Safety: AE
Safety was defined as the Number of Participants With an Adverse Event
Time frame: Up to 36 month
Change From Baseline in HRQoL Score Using EORTC Quality of Life Questionnaire-Oesophageal Module (QLQ-OES18)
The EORTC QLQ-OES18 is a disease-specific questionnaire to assess measurements specific to esophageal cancer. It contains 18 items and is based on four subscales-dysphagia, eating, reflux and pain. All items are scored using a four-point scale that offers these response choices: 1=not at all, 2=a little, 3=quite a bit, 4=very much. A higher score indicates worse level of symptoms. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in HRQoL QLQ-OES18 score in participants will be presented.
Time frame: Up to 36 month
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