Neoadjuvant treatment strategies for advanced esophageal cancer

Biomarker Based Neoadjuvant Strategies for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma: an Exploratory Phase II Single-arm Clinical Study

This study is testing different treatment plans for patients with advanced esophageal cancer to see which one works best based on their CPS score.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fujian Medical University Union Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Fuzhou, Fujian)
• Trial ID: NCT06601309 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of neoadjuvant treatment strategies based on the CPS score in patients with resectable locally advanced esophageal squamous cell carcinoma (ESCC). Patients will undergo CPS testing to determine their treatment plan: those with a CPS score of 20 or higher will receive immunotherapy, while those with scores between 10 and 20 will receive chemotherapy followed by immunotherapy, and those with scores below 10 will receive standard chemoradiotherapy. After treatment, patients will have a surgical assessment for resection feasibility, and the primary outcome will be the rate of pathological complete response (pCR). This approach aims to improve treatment outcomes for patients who currently have limited options.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-75 with histologically confirmed resectable locally advanced esophageal squamous cell carcinoma and an ECOG performance status of 0-1.

Not a fit: Patients with distant metastasis or those who do not meet the specified eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly improve the treatment outcomes for patients with locally advanced esophageal cancer by increasing the rate of pathological complete response.

How similar studies have performed: Other studies have shown promising results with neoadjuvant immunotherapy approaches in similar patient populations, indicating potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

1. Diagnosis: Histologically confirmed esophageal squamous cell carcinoma (ESCC).
2. Stage: Resectable locally advanced ESCC (clinical stage II-III according to the AJCC/UICC 8th edition).
3. Age: 18-75 years old.
4. Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
5. PD-L1 Expression: Available PD-L1 expression level (CPS).
6. Surgical Eligibility: Assessed as eligible for surgical resection by a thoracic surgeon.
7. Laboratory Requirements:

   * Adequate bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L, Platelets ≥ 100 x 10\^9/L, Hemoglobin ≥ 9 g/dL.
   * Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), AST and ALT ≤ 2.5 x ULN.
   * Adequate renal function: Serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 60 mL/min.
8. Informed Consent: Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

1. Distant Metastasis: Presence of distant metastasis.
2. Other Malignancies: History of other malignancies within the past 5 years, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin carcinoma, or other localized non-invasive malignancy.
3. Autoimmune Diseases: History of active autoimmune diseases requiring systemic treatment within the past 2 years.
4. Infections: Active infection requiring systemic therapy.
5. Uncontrolled Conditions: Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
6. Previous Treatment: Previous treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies.
7. Pregnancy and Lactation: Pregnant or breastfeeding women. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization.
8. Allergies: Known allergy or hypersensitivity to study drugs or any excipient of these medications.

Where this trial is running

Fuzhou, Fujian

• Fujian Medical University Union Hospital — Fuzhou, Fujian, China (Recruiting)

Study contacts

• Study coordinator: Zhao-han Lin

Conditions Esophageal Squamous Cell Carcinoma; Esophageal Cancer; Neoadjuvant Therapy; Pathological Complete Response; Immunotherapy; Chemoradiotherapy; Biomarkers