RecruitingPhase 2NCT06463834
A Study of Sintilimab Combined With Chemotherapy for Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma
Sponsor
Fujian Cancer Hospital
Enrollment
30 participants
Start Date
Mar 20, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria6
- ≥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
Exclusion Criteria3
- 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
Interventions
DRUGSintilimab
Sintilimab: 200mg, iv, D1, Q3W; DCF chemotherapy: docetaxel 70mg/m2，iv，d1，Q3W； cisplatin 75mg/m2，iv，d1，Q3W； 5-fluorouracil 750-800mg/m2，iv，d1-d5，Q3W
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06463834
Related Trials
Vebrekotuzumab ± Anti-PD-1 in Pretreated Advanced ESCC
NCT074031361 location
A Study of Sigvotatug Vedotin in Advanced Solid Tumors
NCT04389632154 locations
A Study Evaluating the Safety, Efficacy, and Pharmacokinetics (PK) of EVOLVE104 in Participants With Advanced Urothelial and Squamous Cell Carcinomas
NCT072171718 locations
Substudy 06E: Umbrella Study of Combination Therapies in Esophageal Cancer (MK-3475-06E/KEYMAKER-U06)
NCT0678011141 locations
A Study to Investigate ALE.P02 as Monotherapy in Adult Patients With Selected CLDN1+ Solid Tumors
NCT0674758538 locations