Esophageal Squamous Cell CarcinomaPhase 2NCT07505186
Camrelizumab, Chemotherapy and Ivarmacitinib in Patients With Resectable Esophageal Squamous Cell Carcinoma
A Phase 2 study testing Camrelizumab, Esophagectomy and Sample in people with Esophageal Squamous Cell Carcinoma and Neoadjuvant Therapy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma, Neoadjuvant Therapy
- What is being tested?
- Camrelizumab, Esophagectomy and Sample
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 17 Aug 2026to 31 Dec 2033
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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．
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, China, 310009
Ming Wu, M.D, +8613757118715, iwuming22@zju.edu.cn
Hong Shen, M.D, +8613362891320, shenhong0023@zju.edu.cn
About this study
Official 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
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.
Read the detailed description
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.
- Being tested
- Camrelizumab, Esophagectomy, Sample, Paclitaxel (albumin bound), Carboplatin
- Keywords
- Camrelizumab, Ivarmacitinib
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamrelizumabDrug
The 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.
EsophagectomyProcedure or surgery
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.
SampleOther
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.
Paclitaxel (albumin bound)Drug
The 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.
CarboplatinDrug
The 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.
IvarmacitinibDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative neoadjuvant treatment | 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. Receives: Drug: Camrelizumab; Procedure: Esophagectomy; Other: Sample; Drug: Paclitaxel (albumin bound); Drug: Carboplatin; Drug: Ivarmacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month after surgery
Secondary outcomes (5)
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.
Measured: 1 month after surgery
Imaging assessment: rate of objective response rate (ORR)
The proportion of subjects with imaging PR or CR assessed according to RECIST 1.1 criteria
Measured: before surgery]
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.
Measured: 2-year and 5-year after enrolled
Incidence of Treatment-related Adverse Events
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 1 month after surgery
The changes in the peripheral blood immunoprofile and tumor tissue sample among non-PCR (NPCR) and PCR patients
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.
Measured: 3 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start17 Aug 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianan Wang, Study chair, 2nd Affiliated Hospital, School of Medicine, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07505186
- Sponsor's protocol ID
- 2026-0379
- Status last verified
- Mar 2026
- First submitted
- 26 Mar 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No