Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy for esophageal cancer

Neoadjuvant Chemoimmunotherapy Followed by Surgery and Postoperative Radioimmunotherapy in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma

This study tests a new treatment plan that combines chemotherapy and immunotherapy before surgery, followed by more therapy after surgery, to see if it helps people with advanced esophageal cancer.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Anhui Provincial Hospital (other gov)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Hefei)
• Trial ID: NCT06602843 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness and safety of a treatment regimen that combines neoadjuvant chemoimmunotherapy with subsequent surgery and postoperative radioimmunotherapy in patients diagnosed with locally advanced esophageal squamous cell carcinoma. The approach aims to improve patient outcomes by targeting the cancer before and after surgical intervention. Patients will undergo a radical operation, and their progress will be monitored through imaging and pathological evaluations. The study focuses on a specific patient population with advanced stages of the disease.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with confirmed esophageal squamous cell carcinoma who are eligible for radical surgery and have a postoperative ECOG score of 0-1.

Not a fit: Patients outside the age range of 18-75, those who do not undergo radical resection, or those with non-esophageal squamous cell carcinoma will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for patients with locally advanced esophageal squamous cell carcinoma.

How similar studies have performed: While this specific combination of treatments is being explored, similar approaches in treating esophageal cancer have shown promise in other studies, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

* Ages 18-75;
* Radical operation for esophageal cancer;
* Esophageal squamous cell carcinoma was confirmed by postoperative pathology; . Preoperative imaging (enhanced cervical, thoracoabdominal CT+ bone scan) and postoperative pathological evaluation were performed, and the stage was pIIB-IVA (AJCC eighth edition staging criteria: T≥3 or N+).
* More than or equal to 12 lymph nodes were surgically removed;
* Postoperative ECOG score 0-1, able to tolerate postoperative adjuvant radiotherapy and immunotherapy;
* Informed consent signed by patient or family member.

Exclusion Criteria:

* Less than 18 years old, more than 75 years old;
* did not receive radical resection of esophageal cancer, including palliative resection;
* Postoperative pathology showed non-esophageal squamous cell carcinoma;
* After preoperative imaging (enhanced cervical, thoracoabdominal CT+ bone scan) and postoperative pathological evaluation, the stage was pI, IIA, IVB (AJCC eighth edition staging standard); e. Less than 12 lymph nodes were surgically removed;
* Postoperative ECOG score 2-3 points, unable to tolerate postoperative adjuvant radiotherapy and immunotherapy;
* The patient or family member did not sign the informed consent.

Where this trial is running

Hefei

• Anhui provincial hospital — Hefei, China (RECRUITING)

Conditions: Esophageal Squamous Cell Carcinoma, Locally advanced, Chemoimmunotherapy, Radioimmunotherapy