Status:
RECRUITING
Optimization of Treatment Strategy for Unresectable cN3 Esophageal Squamous Cell Carcinoma
Lead Sponsor:
Ruijin Hospital
Conditions:
Esophageal Squamous Cell Carcinoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
Eligible ESCC patients receive a four-cycle regimen of combined chemotherapy plus immunotherapy. Those without disease progression then get definitive radiotherapy with immune maintenance therapy for ...
Eligibility Criteria
Inclusion
- Esophageal squamous cell carcinoma confirmed through histopathology.
- Distant metastasis excluded by CT, MRI, or PET/CT examinations.
- Locally advanced stage: AJCC/UICC eighth edition staging with any T, N3M0.
- Expected survival time of at least 6 months.
- With an ECOG performance status of 0 to 2. Not accompanied by severe pulmonary hypertension, cardiovascular disease, peripheral vascular disease, severe chronic heart disease, or other comorbidities that could impact radiotherapy progress.
- Adequate function of major organs: Hematopoietic function: Hemoglobin ≥100g/L, platelets ≥90×109/L, white blood cells ≥4×109/L. Exceptions may be considered for patients with ECOG 0-1 who have a history of chronic anemia (80-100 g/L), previous low white blood cell levels (3-4×109/L), or reduced platelets (80-90×109/L). Liver function: ALT and AST \<1.5 times the upper limit of normal (ULN), bilirubin \<1.5×ULN. Renal function: Serum creatinine (SCR) ≤140 μmol/L.
- Patients are required to provide informed consent to undergo treatment.
Exclusion
- Existing or prior history of other malignant tumors (except non-melanoma skin cancer) that are uncontrolled or not cured, depending on the type of the primary tumor.
- Lack of histological or cytological diagnosis for esophageal cancer.
- Previous chest radiotherapy.
- Suffering from innate or acquired immune function defects;
- Pregnancy (confirmed by serum or urine β-HCG test) or during the lactation period; History of drug abuse or alcohol dependence; HIV-positive status, including those on antiretroviral treatment; Chronic hepatitis B with viral replication phase; Active phase of hepatitis C; Active syphilis with a history of mental illness that may hinder treatment completion.
- Poor overall health status, defined as KPS \< 70 or ECOG \> 2.
- Presence of severe comorbidities that could impact radiotherapy progress, including: Unstable angina, congestive heart failure, or myocardial infarction requiring hospitalization within the past 6 months; Acute bacterial or systemic fungal infections; Exacerbation of chronic obstructive pulmonary disease or other respiratory conditions requiring hospitalization; Hepatic or renal insufficiency; Immunosuppressed patients; Coexisting connective tissue diseases, such as active scleroderma or lupus, which are contraindications to radiotherapy.
- Inability to comprehend the treatment's purpose or unwillingness to sign the treatment consent form.
- Lack of legal capacity or limited legal capacity.
Key Trial Info
Start Date :
November 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06122493
Start Date
November 1 2022
End Date
November 1 2026
Last Update
November 8 2023
Active Locations (1)
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1
Ruijin hospital, Shanghai jiaotong university school of medicine
Shanghai, Shanghai Municipality, China, 200025