Safety and Efficacy of Neoadjuvant Immunochemotherapy in Elderly Patients With Resectable Esophageal Cancer

Trial Title: Safety and Efficacy of Neoadjuvant Immunochemotherapy in Elderly Patients With Resectable Esophageal Cancer

NCT ID: NCT06403878

Condition: Esophageal Cancer

Conditions: Official terms:
Esophageal Neoplasms
Paclitaxel
Carboplatin

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Carboplatin
Description: neoadjuvant chemotherapy，2cycles.

Intervention type: Drug
Intervention name: Nab paclitaxel
Description: neoadjuvant chemotherapy，2cycles.

Intervention type: Drug
Intervention name: Sintilimab
Description: neoadjuvant immunotherapy，2cycles.

Summary: 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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Age: ≥70 years (no age limit, with super-elderly patients, such as those ≥80 years, the investigator will assess whether to include them based on the actual situation; gender is not restricted). 2. ECOG PS: 0-1 points; and G8 score ≥14 points. (Patients with G8 scores <14 points will undergo Comprehensive Geriatric Assessment (CGA), and the investigator will decide on inclusion based on the assessment results). 3. Pathologically confirmed esophageal squamous cell carcinoma. 4. No history of prior anti-tumor treatment. 5. Clinical stage is T2-4aN0M0 or T1-4aN+M0, and MDT evaluation deems the patient operable (AJCC staging eighth edition). 6. Adequate organ function: - Hematological tests (within 7 days, without the use of hematopoietic growth factors and transfusion): Granulocyte count ≥1.5×10^9/L, platelet count ≥80×10^9/L, hemoglobin ≥80g/L. - Biochemical tests: Total bilirubin ≤1.5×ULN (upper limit of normal), blood alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤2.5×ULN; creatinine clearance rate ≥60 mL/min (Cockcroft-Gault formula). - Coagulation function: INR or PT ≤1.5×ULN (upper limit of normal). If the subject is receiving anticoagulant therapy, PT within the designated range of anticoagulant drugs is acceptable. - Cardiac function assessment: Normal electrocardiogram or an abnormal electrocardiogram (deemed clinically insignificant by the investigator); cardiac Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) ≥50%. 7. Willing to voluntarily participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up. Exclusion Criteria: 1. Concurrent presence of other malignant tumors. 2. Active autoimmune diseases or a history of autoimmune diseases, such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (eligible after normal hormone replacement therapy). 3. Uncontrollable severe systemic diseases (involving the central nervous system, cardiovascular system, hematological system, digestive system, endocrine system, respiratory system, urogenital system, immune system, etc.) and patients with mental illness. 4. Severe cardiovascular events: heart failure (NYHA III-IV), myocardial infarction, unstable angina, severe arrhythmia, stroke, or cerebral hemorrhage within the last 6 months. 5. Congenital or acquired immunodeficiency (such as HIV infection), active hepatitis B (HBV-DNA ≥ 10^4 copies/mL) or hepatitis C (positive HCV antibodies, and HCV-RNA higher than the detection limit of the analysis method). 6. Allergy or intolerance to the investigational drug. 7. Other conditions deemed unsuitable for inclusion in this study by the investigator.

Gender: All

Minimum age: 70 Years

Maximum age: 100 Years

Healthy volunteers: No

Locations:

Facility:
Name: West-China Hospital

Address:
City: Chengdu
Country: China

Status: Recruiting

Contact:
Last name: zhenyu ding

Phone: +86 85421104
Email: dingzhenyu@scu.edu.cn

Contact backup:
Last name: Zhen Lin

Phone: +86 85421104
Email: linzhenzlk@163.com

Start date: May 2024

Completion date: August 2026

Lead sponsor:
Agency: Sichuan University
Agency class: Other

Source: Sichuan University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06403878