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.
This trial is a prospective, single-center, observational clinical trial evaluating the combination therapy of camrelizumab,apatinib and hyperfractionated radiotherapy in patients with renal cell carcinoma(RCC). All enrolled patients will receive the following treatments: camrelizumab 200mg every 2 weeks for 1 years combined with apatinib 250mg everyday until disease progression (as determined by RECIST 1.1), intolerance, or patient/physician decision to stop treatment. 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. 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 30 study participants.
Study Type
OBSERVATIONAL
Enrollment
30
Immunotherapy, anti-angiogenesis targeted therapy combined with hyperfractionated radiotherapy
Objective response rate(ORR)
Objective response rate, which is defined as the proportion of subjects who achieve a best response of complete response (CR) or partial response (PR) using the RECIST 1.1 criteria.
Time frame: 3 years
Subject safety
Number of Adverse Events using NCI CTCAE 5.0
Time frame: Date of signing of informed consent form until 12 weeks after the last medication
Progression free survival (PFS)
The date of first treatment until the date of progression using the RECIST 1.1 criteria, or death due to any cause, whichever comes first.
Time frame: 3 years
Disease control rate(DCR)
Disease control rate, which is defined as the proportion of subjects who achieve a response of complete response,partial response and stable disease (PR+CR+SD) in the total number of evaluable subjects using the RECIST 1.1 criteria.
Time frame: 3 years
Overall Survival(OS)
Overall survival, defined from the date of first treatment to the date of death due to any cause.
Time frame: 3 years
Local Control Rate
Local Control Rate, which is defined as the proportion of subjects who achieve a response of remission and stable disease (PR+CR+SD) evaluated by RECIST 1.1 after radiotherapy.
Time frame: 3 years
Quality of Life: EORTC QLQ-C30 questionnaire
Quality of life, which will be evaluated using the EORTC(The European Organization for Reasearch and Treatment of Cancer) QLQ-C30(Quality of Life Questionnare-Core 30) questionnaire. The questionnaire contains 30 items. Items 29 and 30 are divided into seven levels, which are counted from 1 to 7 points, 1 is very poor, and 7 is very good. Other items are divided into 4 levels: no at all, a little bit, a lot, and very, and they are directly rated from 1 to 4 points.
Time frame: 3 years
Response rate of lesions that did not receive radiotherapy
Response rate of lesions that did not receive radiotherapy, which is defined as the percentage of the number of cases with tumors that have not received radiotherapy in remission and stable disease (PR+CR+SD) in the total number of evaluable cases using the RECIST 1.1 criteria.
Time frame: 3 years
Pathology and genetic testing
The pathology of the primary tumor before treatment, the puncture specimen of the tumor after the end of radiotherapy, and the whole exome sequencing of the tumor pathology after the progression + blood ctDNA detection for the patients who agree to the examination.
Time frame: 3 years
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