Camrelizumab, Chemotherapy and Ivarmacitinib in Patients With Resectable Esophageal Squamous Cell Carcinoma

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study ID
NCT07505186
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Esophageal Squamous Cell Carcinoma
  • Neoadjuvant Therapy

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab, Chemotherapy and Ivarmacitinib — COMBINATION_PRODUCT
    The treatment regimen includes the administration of Camrelizumab at a dose of 200 mg, Paclitaxel (albumin-bound) at 260 mg/m², and Carboplatin with an area under the curve (AUC) of 5. These medications are administered every 3 weeks for a total of 3 cycles. Additionally, Ivarmacitinib 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.
  • Esophagectomy — PROCEDURE
    Prior 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
    Blood, 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.

Study Details

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.

Key Dates

Start date
May 1, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2033

Study Design

Enrollment
45 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Camrelizumab, Chemotherapy and Ivarmacitinib
    The preoperative neoadjuvant therapy consists of 3 cycles, each with a duration of 21 days. Ivarmacitinib tablets are administered orally at a dosage of 4 mg daily during the first and second cycles, but are omitted during the third cycle. Radical surgery is scheduled to occur between 4 to 8 weeks after the final dose of the neoadjuvant therapy. The requirement for postoperative radiotherapy is evaluated based on the patient's clinical condition and pathological stage. Camrelizumab maintenance therapy may be extended for up to 1 year. Throughout the study, patients are monitored until the occurrence of disease progression, withdrawal of informed consent, loss to follow-up, or death.

Primary Outcome Measure

Rate of pathological complete response (PCR) [ Time Frame: 1 month after surgery ]

Central Contacts

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