Definitive Proton Radiotherapy Combined With Chemotherapy and Immunotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma: A Phase I Clinical Study

Launched by ANHUI PROVINCIAL HOSPITAL · Jun 15, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat a type of esophageal cancer called esophageal squamous cell carcinoma that has advanced but not spread too far. Researchers want to see if combining a special kind of radiation therapy called proton radiotherapy with chemotherapy and immunotherapy is safe and possibly more effective. Proton radiotherapy is a newer form of radiation that targets the cancer more precisely, which may reduce side effects compared to the usual radiation treatment. Immunotherapy helps the body’s immune system fight cancer, and combining it with proton therapy might improve results by protecting immune cells during treatment.

Adults aged 18 to 75 with confirmed esophageal squamous cell carcinoma that cannot be removed by surgery may be eligible for this study, especially if their overall health is good enough to handle treatment. Participants will receive the combined treatment and be closely monitored for side effects and how well the cancer responds. It’s important that patients have not had previous cancer treatments and are expected to live more than six months. This trial is still in the early stages and has not started recruiting yet, but it aims to find safer and more effective options for people facing this challenging diagnosis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18-75 years ECOG performance status 0-1 Histologically confirmed esophageal squamous cell carcinoma (ESCC) Stage II-IVA disease (AJCC 8th edition), confirmed via contrast-enhanced CT of the neck, chest, and abdomen, or PET-CT Unresectable by surgical evaluation or patient refusal of surgery No prior oncologic treatment Life expectancy \>6 months Radiotherapy plan meets physical dose constraints Signed informed consent by patient or legal representative
• Exclusion Criteria:
• • Age \<18 or \>75 years ECOG \>1 or inability to tolerate treatment Histology other than squamous cell carcinoma Stage I or IVB disease High risk of hemorrhage or fistula, as assessed by imaging and radiation oncologists Previously treated patients Life expectancy \<6 months Contraindications to chemotherapy or immunotherapy Radiotherapy plan fails to meet dose constraints Lack of signed informed consent