A Study of Sintilimab Combined With Chemotherapy for Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma
1 other identifier
interventional
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2024
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2024
CompletedStudy Start
First participant enrolled
March 20, 2024
CompletedFirst Posted
Study publicly available on registry
June 18, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 19, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 19, 2028
ExpectedJune 18, 2024
March 1, 2024
12 months
March 13, 2024
June 17, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Pathological complete response
Total tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell
4 weeks after surgery
Secondary Outcomes (3)
Major pathological response
4 weeks after surgery
Disease-free survival period
3-year
Incidence rate of adverse events
3-year
Interventions
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
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2024
First Posted
June 18, 2024
Study Start
March 20, 2024
Primary Completion
March 19, 2025
Study Completion (Estimated)
March 19, 2028
Last Updated
June 18, 2024
Record last verified: 2024-03