Actively Recruiting
Low-dose Radiation Combined With Neoadjuvant Immunochemotherapy for Esophageal Squamous Cell Carcinoma
Led by Sichuan University · Updated on 2025-06-06
30
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to investigate the efficacy and safety of low-dose radiation combined with neoadjuvant chemotherapy and immunotherapy in the treatment of locally advanced thoracic esophageal squamous cell carcinoma. By reducing the radiation dose from 40 Gy in 20 fractions to 4 Gy in 2 fractions, the goal is to lessen the adverse reactions caused by radiotherapy. Additionally, the study explores whether low-dose radiation therapy can promote the cross-presentation of tumor-specific antigens and increase lymphocyte infiltration into the tumor site. Study also examines whether this approach can enhance tumor-specific immune responses, thereby potentially improving the efficacy of immune checkpoint inhibitors.
CONDITIONS
Official Title
Low-dose Radiation Combined With Neoadjuvant Immunochemotherapy for Esophageal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed thoracic esophageal squamous cell carcinoma with clinical staging cT1b-cT2 N1-2 M0 or cT3-cT4a N0-2 M0
- Eligible for R0 curative surgery
- ECOG performance status 0-1
- Male or female aged 18 to 75 years
- Adequate blood counts: WBC 3.5x10^9/L, ANC 1.5x10^9/L, platelets 100x10^9/L, hemoglobin 9 g/dL
- No severe lung dysfunction: FEV1/FVC 70%, FEV1 50% predicted, DLCO >80%
- Liver function within limits: total bilirubin 1.5x ULN, ALT/AST 2.5x ULN, albumin 3 g/dL
- Kidney function: serum creatinine 1.5x ULN or creatinine clearance 60 ml/min
- Voluntary informed consent and ability to comply with study visits
- Expected survival over 6 months
- Agree to surgery, radiotherapy, chemotherapy, and immunotherapy
- Negative pregnancy test for women of childbearing potential within 7 days before treatment
- Willingness to use contraception during and 8 weeks after treatment
- No esophageal perforation or active bleeding, no tracheal or major thoracic vascular invasion
- At least one measurable lesion by imaging according to RECIST 1.1
You will not qualify if you...
- Unsuitable for the immunotherapy or chemotherapy in the protocol
- Previous treatment for esophageal squamous cell carcinoma including drugs targeting PD-1/PD-L1/PD-L2
- History of tumor infiltration causing fistula
- High risk or signs of fistula or perforation
- Systemic corticosteroid or immunosuppressive treatment above allowed doses within 14 days before treatment
- Active autoimmune diseases or history of autoimmune diseases likely to recur
- History of interstitial lung disease, non-infectious pneumonia, or poorly controlled lung disease
- Need for systemic antibacterial, antifungal, or antiviral treatment for infections
- Severe infection requiring hospitalization or recent antibiotic use within 2-4 weeks before treatment
- History of allogeneic organ or hematopoietic stem cell transplant (except corneal transplant)
- Allergic to tiragolumab or combined chemotherapy drugs
- Significant heart rhythm or conduction abnormalities or severe heart failure (NYHA 2)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sichuan University West China Hospital
Chengdu, Sichuan, China, 610000
Actively Recruiting
Research Team
Y
Yong Yuan, Professor
CONTACT
X
Xiaokun Li, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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