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

NCT06403878 | Recruiting Phase 2

• 1 other identifier: SichuanU
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• Pathological complete response rate

  Within two months after surgery

Secondary Outcomes (4)

• one-year Disease-free-survival rate

  Within one year after surgery

• Surgical Completion Rate

  Within two months after surgery

• R0 resection rate

  Within two months after surgery

• Incidence of Adverse events to Neoadjuvant and Surgical Treatment

  From the start of treatment to three months after surgery

Interventions

Carboplatin DRUG

neoadjuvant chemotherapy，2cycles.

Nab paclitaxel DRUG

neoadjuvant chemotherapy，2cycles.

Sintilimab DRUG

neoadjuvant immunotherapy，2cycles.

Eligibility Criteria

• Age: 70 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).
• Pathologically confirmed esophageal squamous cell carcinoma.
• No history of prior anti-tumor treatment.
• Clinical stage is T2-4aN0M0 or T1-4aN+M0, and MDT evaluation deems the patient operable (AJCC staging eighth edition).
• 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%.
• Willing to voluntarily participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up.

You may not qualify if:

• Concurrent presence of other malignant tumors.
• 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).
• 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.
• Severe cardiovascular events: heart failure (NYHA III-IV), myocardial infarction, unstable angina, severe arrhythmia, stroke, or cerebral hemorrhage within the last 6 months.
• 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).
• Allergy or intolerance to the investigational drug.

Sponsors & Collaborators

• Sichuan University: lead

Study Sites (1)

West-China Hospital

Chengdu, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Carboplatin; Taxes; sintilimab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Economics; Health Care Economics and Organizations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 8, 2024
• Study Start: May 1, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)