Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| camrelizumab+apatinib+hyperfractionated radiotherapy | Combination Product | Immunotherapy, anti-angiogenesis targeted therapy combined with hyperfractionated radiotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Subject safety | Number of Adverse Events using NCI CTCAE 5.0 | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Continuous sampling was performed in the Department of Radiotherapy, Peking University First Hospital.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mingwei Ma, MD | Contact | 15810160120 | 15810160120@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xianshu Gao, MD,PhD | Peking University First Hospital | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | 3 years |
| Overall Survival(OS) | Overall survival, defined from the date of first treatment to the date of death due to any cause. | 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. | 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. | 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. | 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. | 3 years |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |