Clinical trial · Interventional
Neoadjuvant CRT Combined With Camrelizumab and Nimotuzumab for Initially Inoperable Patients With Esophageal Carcinoma
Neoadjuvant Chemoradiotherapy Combined With Camrelizumab and Nimotuzumab for Initially Inoperable Patients With Locally Advanced Esophageal Squamous Cell Carcinoma: A Prospective, One-arm, Phase II Study (NCRCN)
- 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)
Neoadjuvant chemoradiotherapy followed by surgery has been the standard modality for locally advance esophageal carcinoma. According to CROSS study, the pathological complete remission rate achieved by paclitaxel and carboplatin with 41.4 Gy/23f was 49% for esophageal squamous cell carcinoma. But the 10-year overall survival rate was only 38%. How to increase the overall survival of esophageal carcinoma is a pivotal task. Both of Camrelizumab and Nimotuzumab have been demonstrated to be efficacious in the neoadjuvant treatment for esophageal squamous cell carcinoma in some small sample-size trials. Therefore, this trial is designed to combine adjuvant chemoradiotherapy with Camrelizumab and Nimotuzumab for resectable \& potentially resectable locally advanced esophageal squamous cell carcinoma and explore the safety and primary efficacy of such combination.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Toxicity, Drug | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| neoadjuvant chemoradiotherapy combined with Camrelizumab and Nimotuzumab followed by surgery | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neoadjuvant treatment
- description
- Neoadjuvant chemoradiotherapy combined with Camrelizumab and Nimotuzumab
- interventionNames
- Drug: neoadjuvant chemoradiotherapy combined with Camrelizumab and Nimotuzumab followed by surgery
Primary outcomes (1)
- measure
- 1-year progression free survival (PFS) rate
- timeFrame
- 0 month post neoadjuvant treatment
- description
- 1-year progression free survival (PFS) rate
Secondary outcomes (5)
- measure
- Rate of adverse events
- timeFrame
- 1 to 2years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 18-75 years old; * Eastern Cooperative Oncology Group (ECOG) 0-1; * Esophageal squamous cell carcinoma; * cT2-4aN0-3M0-1a (AJCC 8th) confirmed by radiological examination; * Initially inoperable at initial diagnosis confirmed by thoracic surgeons; * No esophageal hemorrhage and no esophageal fistula at initial diagnosis; * Treatment naive; * No contraindications for adjuvant chemoradiotherapy, camrelizumab and nimotuzumab; * Signature of inform consent. Exclusion Criteria: * younger than 18 years old or older than 75 years old; * ECOG\>1; * Esophageal adenocarcinoma, small-cell cancer and other pathological types; * Presence of esophageal hemorrhage and esophageal fistula at initial diagnosis; * Previous treatment of chemotherapy, radiotherapy, immune therapy and other treatment; * Contraindications for chemoradiotherapy, camrelizumab and nimotuzumab; * No signature of inform consent.
References
Publications (1)
- DERIVEDHe Y, Liu H, Li X, Wang J, Wu H, Zhou H, Wang X, Cheng J, Ma J, Mei X, Tian J, Qian D. Neoadjuvant chemoradiation with camrelizumab and nimotuzumab for initially inoperable esophageal squamous cell carcinoma: A single-arm phase 2 trial. Eur J Cancer. 2025 Oct 1;228:115717. doi: 10.1016/j.ejca.2025.115717. Epub 2025 Aug 15. PMID 40834785