Actively Recruiting
Immunotherapy in Combination With Chemoradiotherapy in Unresectable Locally Advanced Esophageal Cancer
Led by Shanghai Chest Hospital · Updated on 2023-12-18
50
Participants Needed
1
Research Sites
259 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
SCR-ESCC-02 is a multicenter, phase I/II clinical study to investigate the safety and efficacy of induction immunochemotherapy followed by concurrent chemoradiotherapy with anti-PD-1 therapy in patients diagnosed with locally advanced, unresectable esophageal cancer.
CONDITIONS
Official Title
Immunotherapy in Combination With Chemoradiotherapy in Unresectable Locally Advanced Esophageal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Clinical stage T1N+M0 or T2-4aN0-3M0 according to the 8th UICC-TNM classification
- Unresectable esophageal cancer due to unwillingness for surgery, technical unresectability, or medical unfitness
- No prior anti-tumor treatment including surgery, radiotherapy, chemotherapy, immunotherapy, or targeted therapy
- Adequate blood, lung, heart, liver, kidney, and thyroid function
- Willing to use effective contraception throughout the study
- Provided informed consent
You will not qualify if you...
- History of malignant disease within 5 years before enrollment or presence of other malignant tumors or non-squamous cell carcinoma components
- High risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation
- Weight loss greater than 20% within 90 days before starting treatment
- Presence of long-lasting unhealed wounds or fractures or major surgery within 60 days before treatment
- Severe or uncontrolled coexisting diseases including uncontrolled hypertension, interstitial lung disease or non-infectious pneumonia, active hepatitis B or C, syphilis, or other uncontrolled infections, cardiac insufficiency NYHA 2, renal dysfunction requiring dialysis, active autoimmune disease, or history of immunodeficiency diseases
- Serious arterial or venous blood clots within 6 months before treatment
- History of psychotropic substance abuse or psychotic disorders
- Allergy to study drugs
- Any other conditions judged by investigators to make participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Chest Hospital
Shanghai, China
Actively Recruiting
Research Team
W
Wen Yu, M.D
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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