Radical resection is thought to be the mainstay of esophageal cancer treatment. Neoadjuvant chemoradiotherapy (CRT) followed by surgery has become the standard treatment option for locally advanced esophageal squamous cell cancer (ESCC). However, only 20% to 40% of patients can achieve pathologic complete response (pCR) after neoadjuvant CRT with favorable prognosis and about 10% of patients have disease progression after chemoradiotherapy. How to improve the the efficacy of neoadjuvant therapy is an important clinical problem to be solved. Immunotherapy targeting the programmed cell death receptor-1(PD-1) /programmed cell death-Ligand 1(PD-L1) checkpoints has demonstrated promising activity in ESCC. In Keynote181 study, for patients with metastatic esophageal squamous cell carcinoma, regardless of PD-L1 expression, pembrolizumab significantly improved overall survival compared with chemotherapy. However, the efficacy and safety of immunotherapy therapy in surgery-based multidisciplinary treatment of local advanced esophageal cancer still need a lot of clinical studies to further confirm. This study aims to investigate the safety and efficacy of Toripalimab combined with radiotherapy and chemotherapy in neoadjuvant treatment of locally advanced esophageal squamous cell carcinoma
This study was designed as an open-lable, single-arm, single-center,exploratory clinical study. Toripalimab combination of chemoradiotherapy as neoadjuvant therapy. Participants will receive carboplatin (AUC=2) and paclitaxel liposome (50mg/m²) on day 3,10,17,24,31. And radiotherapy Intensity-modulated radiation therapy(IMRT)will start from day 1 to 31 of chemotherapy. A total of 41.4 Gy, 23 fractions of 1.8 Gy. Participants will also receive Toripalimab (240mg) on days 3, 24and 45. After the neoadjuvant treatment is over, the short-term efficacy evaluation will be performed first, and then a radical resection will be scheduled on Day 59 to 73. This study include 2 phases: 14 cases were enrolled in the first stage and 18 cases were enrolled in the second stage.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Participants will also receive Toripalimab(240mg) VD 30 min on days 3, 24 and 45,3 cycles in total.
Participants will receive carboplatin (AUC=2) VD 30min and paclitaxel liposome (50mg/m²) CIV 24h on day 3,10,17,24,31, 5cycles in total.
A total of 41.4 Gy, 23 fractions of 1.8 Gy on Day 1 to 31.
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
RECRUITINGPathologic complete response rate
Pathologic complete response was defined as pT0N0M0(clinical stage). The rate of pathologic complete response rate after neoadjuvant chemoradiotherapy.
Time frame: Three working days after surgery
Incidence of Treatment-related Adverse Events as Assessed by CTCAE v4.0
The neoadjuvant treatment-related adverse events
Time frame: From the enrollment to the date of surgery
2-year overall survival
The 2-year overall survival of the whole group
Time frame: From date of randomization until the date of death from any cause or the date of last follow-up, whichever came first, assessed up to 24 months
2-year disease-free survival
The 2-year disease-free survival of the whole group
Time frame: From date of surgery until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 24 months.
Major Pathological Response (MPR) rate
MPR is defined as 10% or fewer viable cancer cells in the hematoxylin and eosin (H\&E)-stained slides from the resected tumor following neoadjuvant treatment.
Time frame: From date of surgery to 14 days later
Objective Response Rate (ORR)
Objective response rate is defined as the rate of patients with at least a 30% decrease in the sum of the longest diameter of target lesions, which include complete response (CR) or partial response (PR).
Time frame: At the end of Cycle 2 (each cycle is 21 days)
R0 resection rate
The R0 resection rate of esophagectomy
Time frame: Three working days after surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.