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NCT Number: NCT07505186

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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. The high risk of local recurrence and distant metastasis, which affect patient prognosis and survival rates. Preoperative immunotherapy holds the potential to activate the patient's immune system to recognize tumor antigens and establish immune memory, thereby enabling the immune system to maintain its surveillance role following surgical tumor resection. Consequently, there is a growing emphasis on the administration of immunotherapy prior to surgery across various solid tumor types.

Immune checkpoint inhibitors (ICIs) have shown potential in enhancing the immune system's capacity to target and eliminate cancer cells. However, a substantial subset of patients either responds inadequately or develops resistance to these therapies. To address this challenge, numerous combination treatment strategies have been explored in clinical research. 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. Notably, there is a paucity of research regarding the combination of camrelizumab with chemotherapy and Ivarmacitinib as a neoadjuvant therapy. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Rate of pathological complete response (PCR)

    Time frame: 1 month after surgery

    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.

Secondary outcomes

  1. Rate of major pathological response (MPR)

    Time frame: 1 month after surgery

    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 10%.

  2. Rate of objective response rate (ORR)

    Time frame: before surgery]

    The proportion of subjects with imaging PR or CR assessed according to RECIST 1.1 criteria

  3. 2-year and 5-year event free survival (EFS)

    Time frame: 2-year and 5-year after enrolled

    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.

  4. Incidence of Treatment-related Adverse Events

    Time frame: 1 month after surgery

    Incidence of Treatment-related Adverse Events as Assessed by CTCAE v5.0

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

    Time frame: 3 month after surgery

    By using mass spectrometry (CyTOF), single-cell analysis, and other detecting techniques , we comprehensively characterized the immune landscape in the peripheral blood and tumor sample of ESCC patients before and after anti- PD-1 immunotherapy, aiming to explore the immune subsets correlated with neoadjuvant immunotherapy response.

Study contacts

Contact information is provided by the study sponsor or research team.

Zixiang Wu, M.D

CONTACT

[email protected]

+8615268156132

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

A Prospective, Single-arm, Single-center, Exploratory Study of the Safety and Efficacy of the Combination of Camrelizumab, Chemotherapy and Ivarmacitinib in Patients With Resectable Esophageal Squamous Cell Carcinoma

Important dates

Study start
2026
Primary completion
2028
Study completion
2033
First posted
Apr 1, 2026
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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