NCT04587817

Combination of Hyperfractionated Radiotherapy With Immunotherapy in Massive Tumors

An Observational, Single-center Study of Radiotherapy Combined With Immunotherapy for Massive Tumors

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Peking University First Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial will explore effectiveness and safety using the combination therapy of camrelizumab and hyperfractionated radiotherapy in patients with massive tumor including non-small cell lung cancer, soft tissue sarcoma or urothelial carcinoma. Hypofractionation which represented by stereotactic body radiation therapy (SBRT) is a technique that delivers higher daily doses of radiation over a shorter period of time. This trial will also observe the index which can influencing the curative effect of hyperfractionated radiotherapy combined with immunotherapy.

Detailed description

This trial is a prospective, observational, single-center, single-arm clinical research. This trial will explore effectiveness and safety using the combination therapy of camrelizumab and hyperfractionated radiotherapy in patients with massive tumor including non-small cell lung cancer, soft tissue sarcoma or urothelial carcinoma. All enrolled patients will receive the following treatments: camrelizumab 200mg every 2 weeks until disease progression (as determined by RECIST 1.1), intolerance, or patient/physician decision to stop treatment. One week following completion of the first immunotherapy, hypofractionated radiotherapy(SABR) with tumor center dose of 24-32Gy/8Gy/3-4f and surrounding important organs at risk ≤3.0Gy will be performed. And the routine radiotherapy will be started with reaching a radical cure dose for the tumor margin. Generally, the radiotherapy will end before the fourth immunotherapy. During treatment participants will be assessed for curative effects and the occurrence of adverse events. Following treatment, participants will be assessed at a clinic visit every 3 months to collect survival information and follow-up treatment information. The planned sample size is 60 study participants.

Conditions

• Immunotherapy
• SBRT
• Bulky Tumor

Interventions

Type	Name	Description
COMBINATION_PRODUCT	camrelizumab+hyperfractionated radiotherapy	Immunotherapy combined with hyperfractionated radiotherapy

Timeline

• Start date: 2020-10-15
• Primary completion: 2022-09-19
• Completion: 2023-12-01
• First posted: 2020-10-14
• Last updated: 2020-10-14