Actively Recruiting
A Phase II Clinical Study of Sintilimab Combined with Chemotherapy Followed by Concurrent Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma (ESCC) (NICE-CS)
Led by Shanghai Chest Hospital · Updated on 2024-11-29
52
Participants Needed
1
Research Sites
217 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, single-arm, phase II clinical study designed to evaluate the efficacy and safety of sintilimab combined with chemotherapy, followed by sequential concurrent chemoradiotherapy as conversion therapy, in treatment-naïve esophageal squamous cell carcinoma (ESCC) patients with cT4bN-/+M0 and/or cTanyN+M0 staging (including those with extracapsular invasion of mediastinal lymph nodes).
CONDITIONS
Official Title
A Phase II Clinical Study of Sintilimab Combined with Chemotherapy Followed by Concurrent Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma (ESCC) (NICE-CS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent before any study procedures
- Age between 20 and 75 years, any gender
- Diagnosed with esophageal squamous cell carcinoma with clinical stages cT4bN-/+M0 and/or cTanyN+M0
- Tumor located in the thoracic esophagus
- Primary tumor is inoperable or inoperable due to extracapsular invasion of mediastinal lymph nodes
- ECOG performance status of 0 or 1
- Estimated survival time of at least 6 months
- No prior antitumor therapy for esophageal cancer
- At least one measurable lesion according to RECIST 1.1 criteria
- No surgical contraindications based on organ function evaluation
- Adequate organ function
- Female participants of childbearing potential must have a negative pregnancy test within three days before starting treatment
- Participants of childbearing potential must use effective contraception throughout the study and for a defined period after treatment
You will not qualify if you...
- Diagnosis of other malignancies within 5 years prior to treatment, excluding certain treated skin or cervical cancers
- Presence of or high risk for tracheoesophageal or aortoesophageal fistulas
- Distant metastases
- Participation in other clinical studies or investigational treatments within 4 weeks prior to study drug
- Prior treatment with anti-PD-1, anti-PD-L1, or agents targeting T-cell receptors
- Use of systemic traditional Chinese medicine or immunomodulatory drugs within 2 weeks before treatment (except local control of pleural effusion)
- Active autoimmune disease requiring systemic therapy within 2 years
- Use of systemic corticosteroids or immunosuppressive drugs within 7 days before treatment (except physiological doses)
- History of organ or hematopoietic stem cell transplantation
- Known hypersensitivity to study drugs or excipients
- Incomplete recovery from prior treatment toxicities
- HIV infection
- Untreated active hepatitis B or C infection
- Receipt of live vaccines within 30 days of treatment (except certain inactivated influenza vaccines)
- Pregnant or breastfeeding women
- Recent gastrointestinal bleeding or bleeding disorders
- Severe or uncontrolled systemic diseases including significant heart conditions, unstable angina, recent arterial thrombosis, uncontrolled blood pressure, lung disease, infections, liver diseases, poorly controlled diabetes, significant proteinuria, or psychiatric disorders
- Any other condition that may interfere with study participation or outcomes as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
Research Team
J
Jun Liu
CONTACT
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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