Actively Recruiting
Concurrent Chemoradiotherapy Followed by PD-1 Inhibitor Maintenance Therapy in Locally Advanced Esophageal Squamous Cell Carcinoma: a Randomized Phase III Trial
Led by Fudan University · Updated on 2026-04-17
452
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether combining chemoradiotherapy with immunotherapy as a maintenance treatment can help treat adults with locally advanced esophageal squamous cell cancer. This Phase III trial aims to understand the effectiveness of this approach compared to standard treatments. The study focuses on patients with specific stages of this cancer confirmed by histology and classified by the 8th UICC-TNM system. Participants are randomly assigned to one of four groups: unlimited radiotherapy with PD-1 inhibitor maintenance therapy, unlimited radiotherapy with surveillance, tumor-draining lymph node-sparing radiotherapy with PD-1 inhibitor maintenance therapy, or tumor-draining lymph node-sparing radiotherapy with surveillance. The PD-1 inhibitor is given intravenously at a fixed dose of 200 mg every three weeks for one year after radiotherapy. Chemotherapy with paclitaxel and cisplatin is also part of the treatment. Radiotherapy is delivered at a dose of 50.4 Gy across 28 fractions. During the study, participants will undergo regular assessments to monitor progression-free survival over two years, overall survival, and adverse events related to the treatments. Safety and organ function tests will be conducted, and researchers will closely observe treatment effects and side effects. The study lasts at least two years, including follow-up to track outcomes and safety.
CONDITIONS
Brief Title
CCRT Followed by PD-1 Inhibitor Maintenance Therapy in Locally Advanced ESCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent
- Age 18 years or older
- Histologically confirmed esophageal squamous cell carcinoma
- Clinical stages T3-4N0M0 or TxN+M0 or TxNxM1 (only supraclavicular lymph nodes) based on 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 neutrophil counts ≥1.5×10^9/L, hemoglobin ≥9 g/dl, platelet count ≥100×10^9/L, total bilirubin ≤1.5 times upper limit of normal, AST and ALT ≤2.5 times upper limit of normal, creatinine ≤1.5 times upper limit of normal
You will not qualify if you...
- Esophageal perforation or hematemesis
- Active autoimmune disease or history of autoimmune disease, and use of immunosuppressive or systemic hormonal therapy within 28 days (except for chemoradiotherapy adverse events)
- Prior or current treatment with PD-1 antibody or other immunotherapy targeting PD-1/PD-L1
- Allergy to any ingredients in PD-1 inhibitors
- Uncontrolled heart diseases including NYHA class II or higher heart failure, unstable angina, myocardial infarction within 1 year, or clinically significant arrhythmia requiring intervention
- Congenital or acquired immunodeficiency such as HIV infection, active hepatitis B or C, or active tuberculosis
- Active infection or unexplained fever above 38.5 °C within 2 weeks before randomization (tumor-related fever excepted)
- Pregnancy, breastfeeding, or unwillingness to use contraceptive measures during the trial
- Other serious diseases including mental illness or social factors that may affect safety or data collection, as determined by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 4 weeks
Participants receive chemotherapy with paclitaxel and cisplatin combined with either unlimited or TDLN-sparing radiotherapy as part of their treatment.
Multiple treatment visits over 4 weeks
Duration - 1 year
Participants receive PD-1 inhibitor intravenously at a fixed dose of 200 mg once every 3 weeks for 1 year as maintenance therapy following chemoradiotherapy.
Once every 3 weeks for up to 1 year
Duration - Up to 2 years
Participants who receive radiotherapy without PD-1 inhibitor maintenance therapy are monitored for disease progression and health status.
Regular monitoring visits as scheduled by the study
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
Research Team
K
Kuaile Zhao, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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