Actively Recruiting
An Observational Study on the Safety and Efficacy of Immunotherapy Combined With Concurrent Chemoradiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma
Led by Three Gorges Hospital of Chongqing University · Updated on 2025-07-23
40
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This observational study focuses on elderly patients aged 70 years or older with esophageal squamous cell carcinoma (ESCC). It aims to evaluate the safety and effectiveness of combining immunotherapy with concurrent chemoradiotherapy (CCRT) in treating this condition. The study seeks to measure outcomes such as objective response rate, overall survival, progression-free survival, disease control rate, duration of response, R0 resection rate, adverse events, and potential biomarkers that may predict treatment response. Participants received a combination of treatments including individualized radiotherapy targeting the tumor, platinum-based doublet chemotherapy administered during radiotherapy, and immunotherapy using PD-1 inhibitors like tislelizumab. This retrospective, single-arm study reviews patient outcomes from treatments given between January 2022 and March 2025. Follow-up evaluations occur every three months until disease progression or for up to two years. During the study, participants undergo regular assessments to monitor treatment response and safety. Researchers collect data on tumor response and survival outcomes as primary measures. The study includes follow-up visits every three months to assess ongoing health status and any adverse events. The total observation period extends up to two years or until disease progression, supporting a comprehensive understanding of treatment effects in this patient group.
CONDITIONS
Brief Title
An Observational Study on the Safety and Efficacy of Immunotherapy Combined With Concurrent Chemoradiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary participation with written informed consent
- Age 70 years or older, any gender
- Histologically or cytologically confirmed esophageal squamous cell carcinoma
- Inoperable tumor or refusal of surgery with ability to tolerate anti-tumor treatment
- ECOG performance status between 0 and 2
- Expected survival of at least 6 months
- No severe abnormalities in blood, heart, lung, liver, or kidney function
- No immunodeficiencies
You will not qualify if you...
- Distant organ metastasis except supraclavicular lymph nodes
- Previous esophageal fistula, perforation, or prior treatment for malignancy
- Prior thoracic radiotherapy
- Active autoimmune diseases or history of autoimmune diseases
- Previous or ongoing PD-1 inhibitor treatment or participation in other interventional studies
- Allergy to large protein formulations or components of S-1 capsules
- Uncontrolled cardiac conditions
- Immunodeficiencies 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 screening
- History of other malignancies within 5 years except certain cured skin or cervical cancers
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 - Individualized treatment duration during chemoradiotherapy and immunotherapy
Participants receive concurrent chemoradiotherapy combined with immunotherapy tailored to their condition.
Regular visits during treatment as per clinical care
Duration - Up to 2 years
Participants have regular follow-up assessments every 3 months for up to 2 years to monitor efficacy and safety.
Visits every 3 months for up to 2 years
Trial Site Locations
Total: 1 location
1
Affiliated Shangxia Hospital of Chongqing University
Chongqing, Chongqing Municipality, China
Actively Recruiting
Research Team
H
Han Zhang
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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