A Study of Sintilimab Combined With Chemotherapy for Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma
NCT ID: NCT06463834
Last Updated: 2024-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
30 participants
INTERVENTIONAL
2024-03-20
2028-03-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Sintilimab
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Fujian Cancer Hospital
OTHER_GOV
Responsible Party
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Locations
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Fujian Cancer Hospital
Fuzhou, Fujian, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FujianCH1
Identifier Type: -
Identifier Source: org_study_id
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