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Trial Title:
A Study of Sintilimab Combined With Chemotherapy for Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma
NCT ID:
NCT06463834
Condition:
Esophageal Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Sintilimab
Description:
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 name:
DCF Chemotherapy
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.
Detailed description:
This study was designed as a single arm, phase II trial. Subjects will receive 3 cycles
of Sintilimab combined with DCF as neoadjuvant therapy. The primary endpoint is
pathologic complete response(pCR).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- ≥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 Criteria:
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Zip:
350014
Country:
China
Status:
Recruiting
Contact:
Last name:
Lin An
Phone:
13805015679
Email:
Linan640906@163.com
Start date:
March 20, 2024
Completion date:
March 19, 2028
Lead sponsor:
Agency:
Fujian Cancer Hospital
Agency class:
Other
Source:
Fujian Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06463834
