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).
The patient voluntarily participates in this study, signs the informed consent form, has good compliance, and cooperates with the follow-up;
Age 18-75 years old, including 18 and 75 years old, both male and female;
Histologically or cytologically confirmed clinical stage of locally advanced (T1N1-3M0 or T2-3N0-3M0) thoracic esophageal squamous cell carcinoma (8th UICC-TNM staging);
Enhanced CT of the neck shows no suspicious metastatic lymph nodes (excluding lymph nodes in the esophageal cancer area), and imaging examination shows no distant metastasis;
Patients at high risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation.
Patients with uncontrolled, recurrent pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
Patients with severe dysfunction of the heart, lung, liver, kidney, hematopoietic system, endocrine system, or cachexia.
Patients who have received any of the following treatments: a. Major surgery (except for diagnostic tissue biopsy) or serious trauma within 4 weeks prior to first study drug administration. b. Anti-cancer therapy (including chemotherapy, radiotherapy, immunotherapy, targeted therapy, biotherapy, or tumor embolization) within 4 weeks prior to first study drug administration. c. Any investigational drug within 4 weeks prior to first study drug administration. d. Anti-cancer vaccine or live vaccine within 4 weeks prior to first study drug administration. e. Systemic corticosteroid therapy (>10 mg prednisone equivalent per day) or other immunosuppressants within 2 weeks prior to first study drug administration, except for local inflammation of the esophagus and prevention of allergy and nausea/vomiting.
Single group
BTLA inhibitor (JS004)
DrugBTLA inhibitor (JS004):200mg, intravenous infusion , d1, Q3W;
Toripalimab
DrugToripalimab:240mg,intravenous infusion, d1, Q3W;
Paclitaxel, Cisplatin
DrugPaclitaxel, 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.
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
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
Overall survival (OS)
OS is defined as the time from randomization until death from any cause.
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