In the management of locally advanced esophageal squamous cell carcinoma, the outcomes associated with surgical resection, whether conducted alone or supplemented with postoperative adjuvant radiotherapy and chemotherapy, have been suboptimal. Immune checkpoint inhibitors (ICIs) have shown potential in enhancing the immune system's capacity to target and eliminate cancer cells. Evidence suggests that the concurrent administration of JAK inhibitors with ICIs may improve anti-cancer efficacy, increase patient response rates, and prolong progression-free survival compared to ICIs alone. This prospective, exploratory study aims to assess the efficacy of combining camrelizumab, chemotherapy, and Ivarmacitinib in neoadjuvant treatment for locally advanced esophageal squamous cell carcinoma, with the objective of broadening therapeutic options for this malignancy.
signed informed consent;
patients age 18 to 75 years old
primary resectable, histologically confirmed esophageal squamous cell cancer;
Esophageal squamous cell carcinoma the clinical stage was II-IVA (according to AJCC TNM stage, 8th edition).
with significant cardiovascular disease;
current treatment with anti-viral therapy or HBV;
Female patients who are pregnant or lactating;
history of malignancy within 5 years prior to screening;
Single group
Camrelizumab
DrugThe treatment regimen includes the administration of Camrelizumab at a dose of 200 mg. These medications are administered every 3 weeks for a total of 3 cycles. Camrelizumab maintenance therapy may be extended for up to 1 year.
Esophagectomy
Procedure/SurgeryPrior to each surgical procedure, the department engaged in comprehensive discussions to determine and establish the most appropriate course of action. Depending on the tumor location, a minimally invasive Ivor-Lewis (intrathoracic anastomosis) or McKeown (neck anastomosis) esophagectomy, including two-field extensive lymphadenectomies, was performed. The resection length was required to be at least 5 cm from the tumor origin, as determined by pre-chemotherapy endoscopy. These surgeries were conducted by surgeons with extensive experience. Minimally invasive esophagectomy could be performed using the da Vinci surgical robot, thoracoscope, or laparoscope, or through an open approach, as deemed appropriate by the surgeon.
Sample
Other interventionBlood, Tumour will be Collected from participant. Fate of sample is Destruction after use. 5 ml of peripheral blood was collected the day before each of the immunotherapy sessions and after surgery. Tumour sample will be collected before neoadjuvant therapy and during surgery.
Paclitaxel (albumin bound)
DrugThe treatment regimen includes the administration of Paclitaxel (albumin bound) at 260 mg/m². These medications are administered every 3 weeks for a total of 3 cycles.
Carboplatin
DrugThe treatment regimen includes the administration of Carboplatin with an area under the curve (AUC) of 5. These medications are administered every 3 weeks for a total of 3 cycles.
Ivarmacitinib
DrugIvarmacitinib tablets are administered orally at a dosage of 4 mg daily during the first and second cycles, but are omitted during the third cycle, totaling 42 days of administration.
Pathological assessment: rate of pathological complete response (PCR)
The proportion of the surgical population with PCR, which was defined no residual invasive tumor cells were found in the pathological examination of resected specimens, including the primary tumor and lymph nodes.
Pathological assessment: rate of major pathological response (MPR)
The proportion of the surgical population with MPR, which was defined in the pathological examination of resected specimens, the proportion of residual tumor cells was less than ten percent.
Imaging assessment: rate of objective response rate (ORR)
The proportion of subjects with imaging PR or CR assessed according to RECIST 1.1 criteria
2-year and 5-year event free survival (EFS)
The proportion of study cases from the time of enrollment to either the occurrence of disease recurrence or death from any cause, whichever occurred first, was analyzed within both 2-year and 5-year intervals.
Incidence of Treatment-related Adverse Events
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
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