Immunochemotherapy ± Salvage Chemoradiation for Local Recurrence of Esophageal Squamous Cell Carcinoma After Definitive Chemoradiotherapy

Immunochemotherapy ± Salvage Chemoradiation for Local Recurrence of Esophageal Squamous Cell Carcinoma After Definitive Chemoradiotherapy (ESO-Nanjing12)

The combination of programmed death receptor 1 (PD-1) inhibitors with chemotherapy has been recognized for the treatment of advanced and metastatic esophageal squamous cell carcinoma (ESCC). To the best of our knowledge, there is no published report to date which analyzes the efficacy and safety of this regimen in the treatment of locally primary-recurrent ESCC patients after definitive chemoradiotherapy or radiotherapy only. This is a prospective clinical study designed to enroll 79 patients. The study will focus on those who have attained a complete response (CR) subsequent to definitive chemoradiotherapy or radiotherapy and have a histologically proven in-field recurrence, with no distant metastases. These patients will receive treatment with a PD-1 inhibitor combined with monotherapy chemotherapy for 4 cycles, followed by a 2-year maintenance treatment with PD-1 inhibitors. During this period, patients diagnosed with esophageal wall thickening and identified as having progressive disease (PD) have the option to undergo salvage radiotherapy in conjunction with a dual-agent chemotherapy for 5 cycles. The primary endpoint of is 2-year after recurrence survival (ARS) rate. The secondary endpoints include the progression-free survival (PFS) and safety.

Inclusion Criteria:

-1.Age ≥18 years, regardless of gender. 2.Pathologically confirmed local recurrence of esophageal squamous cell carcinoma after definitive chemoradiotherapy.

3.With or without regional lymph node metastasis, but no distant metastasis. 4.Ineligible for surgery or refusal to undergo surgical intervention. 5.Tolerance to chemotherapy, radiotherapy, and immunotherapy. 6.ECOG performance status 0-2. 7.Life expectancy ≥3 months. 8.No severe hematopoietic, cardiac, pulmonary, hepatic, renal dysfunction, or immunodeficiency.

Exclusion Criteria:

• 1. Esophageal perforation or hematemesis. 2.Distant metastasis in patients after definitive chemoradiotherapy. 3.History of drug abuse, chronic alcoholism, or HIV/AIDS. 4.Myocardial infarction within ≤6 months. Patients with myocardial infarction >6 months ago must undergo myocardial thallium scan to confirm absence of myocardial ischemia and obtain cardiologist approval for chemotherapy.

  5.Uncontrolled seizures or psychiatric disorders impairing decision-making capacity.

  6.Severe allergic history or hypersensitivity. 7.Other conditions deemed unsuitable for study participation by the investigator.