NCT04523883

Concurrent Immunotherapy With Postoperative Radiotherapy in Intermediate/High Risk HNSCC Patients Unfit for Cisplatin: The IMPORT Study (IMPORT)

Randomized Phase II Trial of Postoperative Radiotherapy With Concurrent JS001（PD-1 Antibody） vs. Postoperative Radiotherapy Alone in Intermediate/High-risk Head and Neck Cancer Patients With a Contraindication to Cisplatin

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 316 (estimated)
• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To investigate weather concurrent JS001 with postoperative radiotherapy would have survival benefit in intermediate/high Risk HNSCC Patients who cannot take cisplatin

Conditions

• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
RADIATION	postoperative radiotherapy	postoperative radiotherapy with a dose of 60-66Gy
DRUG	JS001	JS001 240mg every three week

Timeline

• Start date: 2020-08-10
• Primary completion: 2022-08-09
• Completion: 2024-08-09
• First posted: 2020-08-24
• Last updated: 2021-04-15

Locations

1 site across 1 country: China