NCT05355168CompletedPhase 2
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 · Last updated 31 Dec 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 35 (actual)
- First submitted
- 16 Apr 2022
- Start date
- 1 Nov 2021
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Anhui Provincial Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05355168
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 35
- From 1 Nov 2021 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment of chemotherapy, radiotherapy, immune therapy and other treatment;
Other illness
- Esophageal adenocarcinoma, small-cell cancer and other pathological types;
- Presence of esophageal hemorrhage and esophageal fistula at initial diagnosis;
Age
- younger than 18 years old or older than 75 years old;
Other
- ECOG\>1;
- Contraindications for chemoradiotherapy, camrelizumab and nimotuzumab;
- No signature of inform consent.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Anhui Provicial Hospital Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.