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.
Age range: 18-70 years, both male and female.
Patients with histopathological diagnosis of esophageal squamous cell carcinoma confirmed by gastroscopy/ultrasound gastroscopy, and clinical diagnosis of cT2N1-2M0 or cT3N0-2M0, with TNM staging of stage II-III B.
Non-cervical esophageal cancer patients.
No prior systemic or local treatment for esophageal cancer, with at least one measurable lesion for imaging evaluation of neoadjuvant therapy according to RECIST 1.1 criteria.
Patients who have had or currently have other malignant tumors within the past 1.5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invades lamina propria)].
Patients with ulcerative esophageal squamous cell carcinoma.
Patients with esophageal fistula or tracheal fistula.
Patients allergic to anlotinib, toripalimab, or albumin-bound paclitaxel.
Single group
Toripalimab
DrugToripalimab, 240mg, IV., D1, every 3 weeks, 4 cycles.
Anlotinib hydrochloride
DrugAnlotinib 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
DrugAlbumin paclitaxel, 200-260 mg/m2, IV., D1, every 3 weeks, 4 cycles.
Cisplatin
DrugCisplatin, 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
R0 resection rate
Residual tumor rate
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
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.
Disease-free survival (DFS)
Survival without local or systemic recurrence
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