Actively Recruiting
Safety and Efficacy of Neoadjuvant Immunochemotherapy in Elderly Patients With Resectable Esophageal Cancer
Led by Sichuan University · Updated on 2024-05-08
68
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
We intend to conduct a prospective single-arm clinical study to explore the efficacy and safety of immunochemotherapy in neoadjuvant therapy in elderly patients with advanced esophageal squamous cell carcinoma. Most previous randomized controlled studies (such as the 5010 study) have excluded older patients ≥70 years of age. However, in the real world, elderly patients with esophageal cancer account for a large number of patients, and elderly people have many complications and poor tolerance to treatment, which limits the application of synchronous chemoradiotherapy in this group. There is no standard treatment plan for patients over 70 years old, and the purpose of this study is to explore the effectiveness and safety of neoadjuvant immunochemotherapy in the treatment of this group of elderly people.
CONDITIONS
Official Title
Safety and Efficacy of Neoadjuvant Immunochemotherapy in Elderly Patients With Resectable Esophageal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 70 years or older; patients aged 80 and above will be assessed individually by the investigator
- ECOG performance status of 0 or 1 and a G8 score of 14 or higher; patients with G8 less than 14 will undergo a Comprehensive Geriatric Assessment
- Pathological confirmation of esophageal squamous cell carcinoma
- No prior anti-tumor treatment
- Clinical stage T2-4aN0M0 or T1-4aN+M0 with operability confirmed by a multidisciplinary team
- Adequate organ function including hematologic, biochemical, coagulation, and cardiac function within specified limits
- Willingness to participate voluntarily, sign informed consent, comply with study procedures, and follow-up
You will not qualify if you...
- Presence of other malignant tumors
- Active or history of autoimmune diseases such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (unless adequately treated)
- Uncontrolled severe systemic diseases affecting major organs or systems and mental illness
- Severe recent cardiovascular events including heart failure (NYHA III-IV), myocardial infarction, unstable angina, severe arrhythmia, stroke, or cerebral hemorrhage within 6 months
- Immunodeficiency conditions such as HIV infection or active hepatitis B or C with high viral load
- Allergy or intolerance to study drugs
- Other conditions judged unsuitable for study participation by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
West-China Hospital
Chengdu, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
0
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