NCT06463834RecruitingPhase 2
A Study of Sintilimab Combined With Chemotherapy for Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma
Source: ClinicalTrials.gov · Last updated 18 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study is aimed to evaluate the efficacy and safety of sintilimab combined with chemotherapy (docetaxel+cisplatin+5-fluorouracil, DCF) in neoadjuvant treatment of locally advanced esophageal squamous cell carcinoma.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 13 Mar 2024
- Start date
- 20 Mar 2024
- Primary completion date
- 19 Mar 2025
- Lead sponsor
- Fujian Cancer Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06463834
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From 20 Mar 2024 to the primary completion date, 19 Mar 2025
- 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
- Patients who have received any anti-tumor therapy for the research disease in the past, including radiotherapy, chemotherapy, immunotherapy (including but not limited to interleukin, interferon, thymus hormone) and traditional Chinese medicine therapy
Other illness
- Patients with active malignancy within 5 years other than the tumor studied in this study or a localized tumor that has been cured such as resected basal or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or breast cancer
- Patients who have a higher risk of bleeding or perforation due to the tumor's obvious invasion of the adjacent organs (aorta or trachea) of the esophageal lesion, or patients who have formed a fistula
Who the study is looking for
- ≥18 years old and ≤75 years old
- Esophageal squamous cell carcinoma diagnosed biopsy histopathology
- The primary tumor is located in the middle of the esophagus and T1b-3N1-3M0 /M1 or T3N0M0 diagnosed by CT/MRI/EUS (AJCC 8th)
- At least one measurable lesion
- Eastern cooperative oncology group (ECOG) performance status of 0 to 1
- With adequate organs function
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 |
|---|---|---|---|
| Fujian Cancer Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.