Clinical trial · Interventional
Camrelizumab, Chemotherapy and Ivarmacitinib in Patients With Resectable Esophageal Squamous Cell Carcinoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Neoadjuvant Therapy | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Camrelizumab, Chemotherapy and Ivarmacitinib | Combination Product | — | UNRESOLVED |
| Esophagectomy | Procedure | — | UNRESOLVED |
| Sample | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Camrelizumab, Chemotherapy and Ivarmacitinib
- description
- 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.
- interventionNames
- Combination Product: Camrelizumab, Chemotherapy and Ivarmacitinib
- Procedure: Esophagectomy
- Other: Sample
Primary outcomes (1)
- measure
- Rate of pathological complete response (PCR)
- timeFrame
- 1 month after surgery
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. signed informed consent; 2. patients age 18 to 75 years old 3. primary resectable, histologically confirmed esophageal squamous cell cancer; 4. Esophageal squamous cell carcinoma the clinical stage was II-IVA (according to AJCC TNM stage, 8th edition). 5. ECOG PS 0-1. 6. No distant metastasis, the diseases could be resectable assessed by thoracic oncologist． Exclusion Criteria: 1. with significant cardiovascular disease; 2. current treatment with anti-viral therapy or HBV; 3. Female patients who are pregnant or lactating; 4. history of malignancy within 5 years prior to screening; 5. active or history of autoimmune disease or immune deficiency; 6. signs of distant metastases.
References
Publications (0)
Data not yet available