Combination of Hyperfractionated Radiotherapy With Immunotherapy in Massive Tumors

Sponsor
Peking University First Hospital
Study ID
NCT04587817
Status
Unknown

Conditions

  • Bulky Tumor
  • Immunotherapy
  • SBRT

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Oct 15, 2020
Status verified
Oct 2020
Primary completion
Sep 19, 2022
Completion
Dec 1, 2023

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: Camrelizumab+Hypofractionated radiation therapy
    Camrelizumab: 200mg every 2 weeks until disease progression (as determined by RECIST 1.1), intolerance, or patient/physician decision to stop treatment. Hypofractionated Radiotherapy(SABR): tumor center dose of 24-32Gy/8Gy/3-4f and surrounding important organs at risk ≤3.0Gy will be performed when one week following completion of the first immunotherapy. 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.

Primary Outcome Measure

Progression free survival (PFS) [ Time Frame: 2 years ]

Central Contacts

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