NCT04212598CompletedPhase 2
The Value of Sintilimab Consolidation Therapy After Definitive Concurrent Chemoradiotherapy for Locally Advanced Thoracic Esophageal Cancer
The Value of Sintilimab Consolidation Therapy After Definitive Concurrent Chemoradiotherapy for Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma, an Open, Prospective, Single-arm Phase II Study
Source: ClinicalTrials.gov · Last updated 10 Dec 2024
Brief summary (registry, in English)
Esophageal cancer is a kind of disease with high incidence and mortality. Definitive concurrent chemoradiotherapy is an important treatment for locally advanced esophageal squamous cell carcinoma. To Investigate the value of immunotherapy consolidation in locally advanced esophageal squamous cell carcinoma after completing radical concurrent chemoradiotherapy.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 21 Dec 2019
- Start date
- 3 Aug 2020
- Primary completion date
- 3 Nov 2024
- Lead sponsor
- Wuhan University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT04212598
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 40
- From 3 Aug 2020 to the primary completion date, 3 Nov 2024
- 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 design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Progression after first-course radiotherapy;
Other illness
- Stage IV esophageal cancer;
- Existing active infection, such as active tuberculosis, hepatitis, etc.;
Other
- Esophageal adenocarcinoma;
- Gastric esophageal junction adenocarcinoma;
- ECOG \> 2;
Who the study is looking for
- ECOG 0-1; Life expectancy \>6 months;
- Stage II/III esophageal cancer;
- Pathology confirmed squamous cell carcinoma;
- Hemoglobin ≥10g/dl, WBC ≥3.0 x 109/L, platelet ≥100 x 109/L; CR≤ 1.0x normal upper limit, total bilirubin ≤ 1.5x normal upper limit, AST and ALT≤ 1.5x normal upper limit, AKP≤ 2.5x normal upper limit;
- Have a full understanding of this study, participate voluntarily, have follow-up conditions and sign the informed consent;
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhongnan Hospital of Wuhan University Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.