Observational Study of Camrelizumab Combined With Apatinib and Hyperfractionated Radiotherapy for Renal Cell Carcinoma

Sponsor
Peking University First Hospital
Study ID
NCT04609293
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This trial will explore effectiveness and safety using the combination therapy of camrelizumab，apatinib and hyperfractionated radiotherapy in patients with renal cell carcinoma(RCC). Hypofractionation is a technique that delivers higher daily doses of radiation over a shorter period of time.immunotherapy. hyperfractionated radiotherapy, represented by stereotactic body radiation therapy (SBRT), can significantly improve the radiotherapy sensitivity of RCC. This trial will also observe whether SBRT can bring about immune effects and explore the group and individual indicators that affect the treatment effect of RCC.

Key Dates

Start date
Oct 20, 2020
Status verified
Oct 2020
Primary completion
Sep 7, 2023
Completion
May 7, 2024

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: Camrelizumab+apatinib+Hypofractionated radiation therapy
    Camrelizumab:200mg every 2 weeks for 1 years or until disease progression (as determined by RECIST 1.1), intolerance, or patient/physician decision to stop treatment. Apatinib:250mg everyday until disease progression (as determined by RECIST 1.1), intolerance, or patient/physician decision to stop treatment. Radiation: one week following completion of the second immunotherapy, hypofractionated radiotherapy with marginal dose of 50Gy/2Gy/25f and tumor center dose of local hyperfraction increase 24-32Gy/8-12Gy/3-4f will be performed 3-5 times. The routine radiotherapy will be started at the same time as the third immunotherapy and 25 times routine radiotherapy will be completed before the fifth or sixth immunotherapy.

Primary Outcome Measure

Objective response rate（ORR） [ Time Frame: 3 years ]

Central Contacts

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