A Study of Multimodal Radiotherapy for Renal Cell Carcinoma Progressed After Prior Immunotherapy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorJinling Hospital, China
About this trial
The objective of this single-center clinical study was to evaluate the disease control rate(DCR) and safety of multimodal radiotherapy in the treatment of patients with renal cell carcinoma (RCC) progressed after prior immunotherapy.
Eligibility criteria
Qualifiers
Renal cell carcinoma confirmed histologically or cytopathologically, including unresectable or recurrent metastatic renal cell carcinoma.
Subject's previous treatment: Disease progression or intolerance following prior treatment with 1-2 systemic therapies (at least one regimen containing immune checkpoint inhibitors, including combined VEGFR-TKI drugs), And patients who have progressed within 12 months of prior immunoadjuvant or neoadjuvant therapy; According to the evaluation of attending physicians and professional radiotherapy doctors, it meets the standard of radiotherapy.
Patients can tolerate sequential immunotherapy while receiving radiation therapy.
At least two or more metastases at different sites are considered observable according to RECIST v1.1.
Disqualifiers
A history of malignancies other than the disease studied within the past 5 years, other than malignancies that are expected to be cured with treatment (including but not limited to adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or breast ductal carcinoma in situ treated with radical surgery).
Systemic treatment with other antitumor agents, including targeted agents, immunotherapy agents and their combination regimens (eligible for inclusion after 5 half-lives), local antitumor therapy, or clinical investigational drug or device therapy, was administered 4 weeks prior to the first study.
Previous history of radiation therapy at any site or in any mode.
Had major surgery (as judged by the investigator) within 4 weeks prior to the first trial or was convalescing.
Trial design
Treatments tested in this trial
- High-dose Radiotherapy (HDRT)
- Low-dose Radiotherapy (LDRT)
- Anti-PD-1 monoclonal antibody
Treatment groups
35 Participants
are divided into 1 treatment groupLocations
1Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University210000, NanjingJiangsu, China
Sponsors and collaborators
Jinling Hospital, China
Lead sponsor
Source ClinicalTrials.gov