Actively Recruiting
Sintilimab as Additional Treatment After Surgery in Node-positive Esophageal Squamous Cell Carcinoma Without Prior Neoadjuvant Therapy
Led by Zhejiang Cancer Hospital · Updated on 2024-01-05
31
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of sintilimab as an additional treatment for people with node-positive esophageal squamous cell carcinoma who have undergone radical surgery without prior neoadjuvant therapy. The goal is to assess how well sintilimab works and how safe it is when given after surgery. This is a Phase 2 clinical trial sponsored by Zhejiang Cancer Hospital focusing on this specific type of esophageal cancer. Participants in the study will receive sintilimab at a dose of 200 mg given once on day 1, repeated every 21 days. This adjuvant therapy is intended to be administered after the surgical removal of the cancer. The study does not include a placebo or comparison group, and the treatment will continue according to this schedule. Throughout the study, participants will be monitored regularly, with disease-free survival being tracked for up to 36 months as the primary outcome. Overall survival will also be assessed for up to 60 months. Evaluations will include physical and imaging examinations such as CT or MRI scans of the neck, chest, and abdomen, as well as laboratory tests to check blood counts and organ function. Safety and adherence to treatment will be carefully observed during follow-up visits over the study period.
CONDITIONS
Brief Title
A Clinical Study of Sintilimab as Adjuvant Therapy in Node-positive ESCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed an informed consent form
- ECOG performance status of 0 or 1
- Histologically confirmed thoracic esophageal squamous cell cancer stage T1-3N+M0 (AJCC 8th edition)
- Able to tolerate radical esophageal cancer surgery
- Surgery performed within 4 to 12 weeks before enrollment
- Confirmed disease-free status by physical and imaging exams (CT/MRI of neck, chest, abdomen) within 4 weeks prior to enrollment
- Baseline lab tests within 28 days before enrollment meeting specific blood count and organ function criteria
- Age 18 years or older
- Women of childbearing potential must have a negative pregnancy test within 24 hours before starting treatment
- Women must not be breastfeeding
You will not qualify if you...
- Presence of locally advanced unresectable or metastatic esophageal cancer
- Cervical or abdominal esophageal tumors
- Previous treatment after surgery for esophageal cancer (chemotherapy, targeted drugs, radiation, biotherapy)
- Peripheral neuropathy of grade 2 or higher
- Active, known, or suspected autoimmune diseases (with some exceptions such as type I diabetes or certain skin conditions)
- Use of glucocorticoids or immunosuppressive drugs above specified doses within 14 days before treatment
- Known HIV infection or AIDS
- Serious or uncontrolled medical conditions
- Prior radiotherapy, chemotherapy, immunotherapy, or major esophageal or gastric surgery before this trial
- Severe cardiovascular or pulmonary diseases, interstitial pneumonia, or history of interstitial pneumonia
- Active malignancy within the last 3 years except certain cured cancers
- Active hepatitis B or C infection
- Allergy or hypersensitivity to study drug or monoclonal antibodies
- Inability to understand or comply with trial requirements
- Active infections requiring systemic treatment within 28 days before first dosing
- Other significant diseases deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Every 21 days dosing cycles until disease progression or discontinuation
Participants receive sintilimab as additional treatment after surgery for node-positive esophageal squamous cell carcinoma.
Visits every 3 weeks for drug administration and monitoring
Duration - Up to 60 months
Participants are monitored for disease-free survival and overall survival after treatment ends.
Periodic visits for up to 60 months
Trial Site Locations
Total: 1 location
1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
Research Team
C
Changchun Wang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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