A Study of Sintilimab Combined With Chemotherapy for Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma
Recruiting now · Phase 2
Conditions studied: Esophageal Squamous Cell Carcinoma
In brief
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.
Key facts
- Study ID
- NCT06463834
- Run by
- Fujian Cancer Hospital
- People needed
- 30
- Starts
- 2024-03-20
- Expected to finish
- 2028-03-19
- Last updated by the study team
- 2024-06-18
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥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
You may not qualify if…
- 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
- 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
Where it is running
- Fujian Cancer Hospital — Fuzhou, Fujian, China (enrolling)
Full record on ClinicalTrials.gov
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