Neoadjuvant immunochemotherapy for elderly patients with esophageal cancer

Prospective, Single-arm, Phase II Study of Nab-paclitaxel Plus Carboplatin in Combination With Sintilimab for Neoadjuvant Therapy in Elderly, Locally Advanced, Resectable Esophageal Squamous Cell Carcinoma.

This study is testing a new combination of immunotherapy and chemotherapy to see if it helps older patients with esophageal cancer before surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Ages: 70 Years to 100 Years
• Sex: All
• Sponsor: Sichuan University (Academic / other)
• Locations: 1 site (Chengdu)
• Trial ID: NCT06403878 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and efficacy of neoadjuvant immunochemotherapy using Carboplatin, Nab paclitaxel, and Sintilimab in elderly patients aged 70 and above with resectable esophageal squamous cell carcinoma. The study addresses a significant gap in existing research, as older patients are often excluded from clinical trials, despite representing a large portion of the esophageal cancer population. By focusing on this demographic, the trial seeks to determine an effective treatment strategy that accommodates the unique challenges faced by elderly patients, including comorbidities and treatment tolerance. The study will be conducted as a prospective single-arm trial, allowing for a thorough assessment of outcomes in this specific patient group.

Who should consider this trial

Good fit: Ideal candidates for this study are elderly patients aged 70 years and older with operable esophageal squamous cell carcinoma and no prior anti-tumor treatment.

Not a fit: Patients with significant comorbidities that severely limit their treatment tolerance or those with advanced metastatic disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a tailored treatment option for elderly patients with esophageal cancer, improving their chances of successful surgery and overall survival.

How similar studies have performed: While there is limited research specifically targeting elderly patients with esophageal cancer, similar approaches in other cancers have shown promise, indicating potential for success in this novel application.

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.

Where this trial is running

Chengdu

• West-China Hospital — Chengdu, China (Recruiting)

Conditions Esophageal Cancer