Establishing Best Treatment Strategy for T4 Esophageal Cancer

The treatment of T4-stage esophageal cancer is challenging because of a high esophageal perforation rate (19%) after concurrent chemoradiotherapy. This research aims to investigate whether a novel sequential chemoradiotherapy approach can improve the treatment response rate and reduce the incidence of esophageal perforation in participants with T4-stage esophageal cancer. The proposed novel treatment strategy involves induction chemotherapy for 4 to 8 cycles. It is followed by concurrent chemoradiotherapy if down-stage had been achieved by induction chemotherapy. The study will be conducted in two phases, starting with a phase I study to determine safety, followed by a phase II study to evaluate overall efficacy. Expected outcomes include improved treatment response rates and reduced esophageal perforation rates in T4-stage esophageal cancer, offering a better treatment option for these patients.

Inclusion criteria

• Histologically confirmed esophageal squamous cell carcinoma
• Tumor or lymph nodes invade adjacent organs (T4 stage)
• Aged between 18-70 years old
• Patient health status score Eastern Cooperative Oncology Group (ECOG) performance status (PS) <2
• Hemoglobin ≥ 10 g/L, absolute neutrophil count ≥ 2×10^3/L, platelet count ≥ 100×10^9/L, total bilirubin ≤ 1.5 mg/L, serum transaminases ≤ 105 U/L, creatinine clearance ≥ 40 mL/min.

Exclusion criteria

• Previous chemotherapy history
• Myocardial infarction within the last three months
• History of unstable angina, interstitial pneumonia, fibrotic lung disease, or severe emphysema
• Has other malignancies currently
• Uncontrolled infection
• Pregnancy or lactation
• Perforated esophagus at the time of diagnosis