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Trial Title:
Short-course Radiotherapy Combined With Sintilimab for Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma
NCT ID:
NCT06468670
Condition:
Esophageal Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Antibodies
Antibodies, Monoclonal
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
sintilimab，programmed death 1 monoclonal antibody
Description:
short-course radiotherapy
+sintilimab (200mg, iv, D1, Q3W)
Arm group label:
short-course radiotherapy+sintilimab
Summary:
This study is aimed to evaluate the efficacy and safety of short-course radiotherapy
combined with sintilimab in neoadjuvant treatment of stage III, locally advanced
esophageal squamous cell carcinoma.
Detailed description:
This study was designed as a single arm, phase II trial. Subjects will receive
short-course radiotherapy combined with sintilimab as neoadjuvant therapy of stage III,
locally advanced esophageal squamous cell carcinoma. 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
- Patients with resectable esophageal squamous cell carcinoma confirmed by
pathology (including histology or cytology) , with pathological stage T3-4 or
N+
- 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
Start date:
June 17, 2024
Completion date:
June 2027
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/NCT06468670
