Actively Recruiting
Optimization of Treatment Strategy for Unresectable cN3 Esophageal Squamous Cell Carcinoma
Led by Ruijin Hospital · Updated on 2023-11-08
48
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to investigate a comprehensive therapeutic approach for patients with unresectable esophageal squamous cell carcinoma, clinically staged as Tany, N3, M0, and who are not candidate for concurrent chemoradiotherapy combined with immunotherapy. The approach entails combining chemotherapy with immune therapy, followed by synchronized radiotherapy during the immune maintenance phase. The primary goal is to mitigate treatment-related side effects and enhance the overall prognosis through the integration of these treatment modalities.
CONDITIONS
Official Title
Optimization of Treatment Strategy for Unresectable cN3 Esophageal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Esophageal squamous cell carcinoma confirmed through histopathology
- No distant metastasis confirmed by CT, MRI, or PET/CT
- Locally advanced stage with any T, N3M0 according to AJCC/UICC 8th edition
- Expected survival of at least 6 months
- ECOG performance status between 0 and 2 without severe pulmonary hypertension, cardiovascular disease, peripheral vascular disease, severe chronic heart disease, or other comorbidities affecting radiotherapy
- Adequate organ function: Hemoglobin 65100 g/L, platelets 6590 x10^9/L, white blood cells 654 x10^9/L (exceptions for ECOG 0-1 patients with specific histories), liver enzymes ALT and AST less than 1.5 times upper limit of normal, bilirubin less than 1.5 times upper limit, and serum creatinine 64140 bcmol/L
- Provide informed consent to treatment
You will not qualify if you...
- History or presence of other uncontrolled or uncured malignant tumors (except non-melanoma skin cancer)
- Lack of histological or cytological diagnosis for esophageal cancer
- Previous chest radiotherapy
- Immune function defects, either innate or acquired
- Pregnancy or lactation period
- History of drug abuse or alcohol dependence
- HIV-positive status or on antiretroviral therapy
- Active chronic hepatitis B or hepatitis C
- Active syphilis or mental illness interfering with treatment
- Poor health status defined as KPS < 70 or ECOG > 2
- Severe comorbidities impacting radiotherapy such as recent unstable angina, congestive heart failure, myocardial infarction, acute infections, exacerbated COPD, hepatic or renal insufficiency, immunosuppression, or connective tissue diseases contraindicating radiotherapy
- Inability or unwillingness to understand or consent to treatment
- Lack or limitation of legal capacity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ruijin hospital, Shanghai jiaotong university school of medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
Research Team
Y
Yifeng Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here