NCT04568200

Study of Anti-PD-L1 in Combination With Chemo(Radio)Therapy for Resectable Esophageal Squamous Cell Carcinoma

A Prospective, Randomized Controlled Study to Evaluate the Efficacy and Safety of Durvalumab Combined With Neoadjuvant Therapy in Patients With Local Advanced Esophageal Squamous Cell Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a study to evaluate the efficacy and safety of preoperative treatment with durvalumab combined with neoajuvant therapy (carboplatin, paclitaxel with/without radiation) in locally advanced resectable oesophageal squamous carcinoma.

Detailed description

The primary objective of the study is to assess the tumor response (by irRECIST) and pathological response of preoperative treatment with durvalumab combined with neoadjuvant therapy (carboplatin, paclitaxel with/without radiation). Secondary objectives are: To assess completion of treatment with durvalumab combined with chemotherapy with/without radiation treatment. To assess toxicities of durvalumab in combination with chemoradiation. \[Time Frame: up to 1 year\] To assess completion of chemotherapy with/without radiation treatment. To assess withdrawal rate from surgery. To assess delay rate from surgery. To assess R0 resection rate. To assess post-operative complications. Progression Free Survival. \[ Time Frame: up to 24 months \] Overall Survival. \[ Time Frame: up to 24 months \]

Conditions

• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Durvalumab	Durvalumab 1500mg i.v. day 1-22-43-64
DRUG	Carboplatin	Chemotherapy
DRUG	Paclitaxel	Chemotherapy
RADIATION	Radiotherapy 23 x 1.8 Gy	Radiotherapy 23 x 1.8 Gy

Timeline

• Start date: 2020-06-19
• Primary completion: 2023-12-01
• Completion: 2024-01-01
• First posted: 2020-09-29
• Last updated: 2024-01-22

Locations

1 site across 1 country: China