Actively Recruiting
TDLN-sparing RT Plus Immunotherapy and Chemotherapy in Locally Advanced ESCC
Led by Fudan University · Updated on 2026-01-07
432
Participants Needed
1
Research Sites
312 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if immunotherapy in combination with tumor draining lymph nodes-sparing radiotherapy (TDLN-sparing RT) and chemotherapy works to treat locally advanced esophageal squamous cell cancer in adults. Researchers will compare immunotherapy in combination with TDLN-sparing RT and chemotherapy to TDLN-sparing RT and chemotherapy to see if immunotherapy works more effectively when using TDLN-sparing RT to treat locally advanced esophageal squamous cell cancer Participants will: TDLN-sparing RT for esophageal cancer 50.4Gy/28Fx Paclitaxel plus cisplatin every 3 weeks for 4 cycles PD-1 inhibitors or observation every 3 weeks for 1 year
CONDITIONS
Official Title
TDLN-sparing RT Plus Immunotherapy and Chemotherapy in Locally Advanced ESCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent
- Aged 18 to 75 years
- Histologically confirmed esophageal squamous cell carcinoma
- Clinical stage T2-4N0M0 or TxN+M0 or TxNxM1 (only for supraclavicular lymph nodes metastasis) based on the 8th UICC-TNM classification
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Life expectancy of at least 3 months
- Adequate organ function including: absolute neutrophil counts (ANC) ≥1.5×10⁹/L; hemoglobin (Hb) ≥9 g/dl; platelet count ≥100×10⁹/L; total bilirubin ≤1.5 times upper limit of normal (ULN); AST and ALT ≤2.5 times ULN; creatinine ≤1.5 times ULN
- Received no more than 3 cycles of immunotherapy and/or chemotherapy
You will not qualify if you...
- Esophageal perforation or hematemesis
- Any active autoimmune disease or history of autoimmune disease (including autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism) and use of immunosuppressive agents or systemic hormonal therapy within 28 days (except for adverse events of chemoradiotherapy)
- Allergy to macromolecular protein preparations or any ingredients of PD-1 inhibitors
- Uncontrolled heart disease or symptoms such as NYHA class II or higher heart failure, unstable angina, myocardial infarction within 1 year, or clinically significant arrhythmia requiring intervention
- Congenital or acquired immunodeficiency (e.g., HIV infection), active hepatitis B or C, or active tuberculosis
- Active infection or unexplained fever above 38.5°C within 2 weeks before randomization (excluding tumor-related fever)
- Patients unwilling to use contraceptive measures during the trial, or female patients who are pregnant or breastfeeding
- Other serious diseases, mental illness, social or family factors that may affect safety or data collection as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
D
Dashan Zhao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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