Local Therapy for Oligometastatic ESCC Patients Treated With PD-1 Inhibitor

Launched by FUDAN UNIVERSITY · Dec 20, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment approach for patients with a specific type of esophageal cancer called oligometastatic esophageal squamous cell carcinoma. This means the cancer has spread to a limited number of places in the body (up to four distant spots), but not extensively. In this trial, participants will be randomly assigned to receive either a combination of a PD-1 inhibitor (a type of immunotherapy) and local therapy (like radiation) with or without chemotherapy, or just the PD-1 inhibitor and chemotherapy alone. The main goal is to see how long patients can live without their cancer getting worse, and they will also look at overall survival, side effects, and how well the local treatment controls the cancer.

To qualify for this trial, participants must be at least 18 years old and have a diagnosis of esophageal squamous cell carcinoma that fits the criteria for oligometastatic disease. This includes having a limited number of metastases (cancer spread), and the size of each lesion must be relatively small. Participants can expect to receive care and monitoring throughout the trial, and they will be contributing to important research that may help improve treatment for future patients with similar conditions. The trial is currently recruiting and is open to all genders, focusing on individuals aged 65 to 74.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. ≥18 years old; 2. ECOG 0-1; 3. Esophageal squamous cell carcinoma 4. ASTRO/ESTRO defined genuine oligometastatic disease and consistent with: i. ≤4 distant metastases, ii. ≤3 metastatic lesions within a single organ, iii. maximum diameter of each metastatic lesion ≤5cm; 5. ≥1 pathologically diagnosed metastases
• Exclusion Criteria:
• • 1. History of disseminated metastases or ASTRO/ESTRO defined induced oligometastatic disease 2.Esophageal perforation/hemorrhage 3.Progression disease after PD-1 inhibitor treatment 4.In-field recurrence 5.Intolerance to chemotherapy or immunotherapy 6.lung V20\>25%