Patient-reported Outcomes in Preoperative Immunochemotherapy/Radiotherapy-treated Esophageal Cancer Patients

• Status: Recruiting
• Trial end date: 2025-09-30
• Target enrollment: 0
• Participant gender: All

Summary

Preoperative Immune checkpoint inhibitors combined with chemotherapy have revolutionized the treatment landscape of locally advanced esophageal squamous cell carcinoma. However, there are still a significant proportion of patients who could not benefit from such treatment modality. Currently, no effective biomarkers were identified to stratify responders and non-responders. Early dynamic and persistent relief of dysphagia may act as a predictive biomarker to reflect the on-treatment anti-tumor activity. In this prospective study, we aimed to explore the feasibility of using patient-reported outcomes (PROs) to predict the pathological complete response of esophageal squamous cell carcinoma patients treated with neoadjuvant immunochemotherapy with or without short-term radiation as well as to assess the efficacy and safety of short-term radiotherapy in PROs-insensitive patients after one cycle of neoadjuvant immunochemotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guangdong Provincial People's Hospital
• Treatments: Carboplatin; Cisplatin; Paclitaxel

Criteria

Inclusion Criteria:

• Pathologically confirmed esophageal squamous cell carcinoma

• Potentially resectable esophageal squamous cell carcinoma at first diagnosis (cT1-4aN1-2M0, cT3-T4aN0M0)

• Treatment-naive

• Expected life span > 6 months

• Aged 18 - 75 years old

• Adequate organ functions

• PS 0-2

• Participants are fully informed about the whole study and are willing to sign the informed consent

Exclusion Criteria:

• Previous history of thoracic surgery or radiation

• Cervical or multi-origin esophageal cancer

• Known or suspected experimental drug allergy

• Pregnant or lactating women

• Esophagomediastianl fistula

• Peripheral neuropathy

• Previous cancer history other than esophageal cancer

• Severe organ function deterioration that can not tolerate neoadjuvant therapy

• Previous autoimmune diseases

• diabetic history > 10 years

• interstitial pulmonary disease, non-infectious pulmonitis

• Active type B hepatitis

• Any other conditions that may affect patients' safety and compliance