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

NCT07505186 | Not Yet Recruiting Phase 2

• 1 other identifier: 2026-0379
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neoadjuvant Therapy; Esophageal Squamous Cell Carcinoma

Keywords

Camrelizumab; Ivarmacitinib

Outcome Measures

Primary Outcomes (1)

• 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.

  1 month after surgery

Secondary Outcomes (5)

• Rate of major pathological response (MPR)

  1 month after surgery

• Rate of objective response rate (ORR)

  before surgery]

• 2-year and 5-year event free survival (EFS)

  2-year and 5-year after enrolled

• Incidence of Treatment-related Adverse Events

  1 month after surgery

• The changes in the peripheral blood immunoprofile and tumor tissue sample among non-PCR (NPCR) and PCR patients

  3 month after surgery

Study Arms (1)

Camrelizumab, Chemotherapy and Ivarmacitinib

EXPERIMENTAL

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.

Combination Product: Camrelizumab, Chemotherapy and Ivarmacitinib; Procedure: Esophagectomy; Other: Sample

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.

Camrelizumab, Chemotherapy and Ivarmacitinib

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.

Camrelizumab, Chemotherapy and Ivarmacitinib

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.

Camrelizumab, Chemotherapy and Ivarmacitinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• ECOG PS 0-1.
• No distant metastasis, the diseases could be resectable assessed by thoracic oncologist．

You may not qualify if:

• 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;
• active or history of autoimmune disease or immune deficiency;
• signs of distant metastases.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, China, 310009, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

camrelizumab; Drug Therapy; ivarmacitinib; Esophagectomy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Jianan Wang

  2nd Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY CHAIR

Central Study Contacts

Zixiang Ｗu, M.D

CONTACT

+8615268156132; zixiang0717@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 1, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2033
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

CN (1)