This is a single-center, single-arm, phase II study, aiming to preliminarily explore the efficacy and safety of JS004 combined with toripalimab and chemotherapy for perioperative treatment of locally advanced thoracic esophageal squamous cell carcinoma that is resectable. The plan is to enroll 20 patients with locally advanced resectable thoracic esophageal cancer. In the neoadjuvant treatment phase, patients will receive JS004 + toripalimab + chemotherapy (paclitaxel + cisplatin) for 2 cycles. This will be followed by the surgical phase: surgery will be performed 3-8 weeks after the last dose of neoadjuvant treatment. In the postoperative maintenance treatment phase, maintenance treatment will start 4 weeks ± 7 days after surgery, but no later than 10 weeks after surgery. For patients with R0 resection confirmed by postoperative pathology, they will receive maintenance treatment with JS004 + toripalimab for up to 15 cycles. For patients with non-R0 resection, they will receive maintenance treatment with JS004 + toripalimab combined with standard radiation or chemotherapy (selected by the investigator based on esophageal cancer guidelines). During the study, the maximum number of cycles of JS004 combined with toripalimab is 17 cycles (approximately 1 year).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
BTLA inhibitor (JS004):200mg, intravenous infusion , d1, Q3W;
Toripalimab:240mg,intravenous infusion, d1, Q3W;
Paclitaxel, 175mg/m2, intravenous infusion, d1, Q3W; Cisplatin, 75mg/m2, intravenous infusion, d1, Q3W;
Pathological complete response rate (pCR)
pCR rate is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy.assessment criteria after neoadjuvant therapy, as defined by the CAP (College of American Pathologists) and NCCN (National Comprehensive Cancer Network) guidelines.
Time frame: up to 3 weeks after neoadjuvant
Major pathological response rate (MPR)
mPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes in neoadjuvant therapy
Time frame: up to 3 weeks after neoadjuvant
Event-free lifetime (EFS)
EFS is defined as the time from randomization until radiographic disease progression, local progression precluding surgery, inability to resect the tumor, local or distant recurrence, or death due to any cause. EFS determined either by biopsy assessed by central pathologist or by imaging using RECIST 1.1 assessed by investigator
Time frame: up to 3 years
Overall survival (OS)
OS is defined as the time from randomization until death from any cause.
Time frame: up to 3 years
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