Trial Title:
A Study of Multimodal Radiotherapy for Renal Cell Carcinoma Progressed After Prior Immunotherapy
NCT ID:
NCT06255223
Condition:
Renal Cell Carcinoma
Radiotherapy
Immune Checkpoint Inhibitor
Conditions: Official terms:
Carcinoma
Carcinoma, Renal Cell
Antibodies
Antibodies, Monoclonal
Conditions: Keywords:
RCC
Multimodal radiotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
High-dose Radiotherapy (HDRT)
Description:
SBRT was adopted, and radiotherapy plan was made according to the location and size of
lesions (total dose 20-70Gy, 5-12Gy every time).
Arm group label:
Experimental group
Other name:
Stereotactic Body Radiation Therapy
Other name:
SBRT
Other name:
Stereotactic Ablative Body Radiation Therapy
Other name:
SABR
Intervention type:
Radiation
Intervention name:
Low-dose Radiotherapy (LDRT)
Description:
Radiotherapy plan was made according to the location and size of lesions (total dose 2Gy,
1Gy every time). After completing SBRT, LDRT was performed on as many metastatic sites as
possible.
Arm group label:
Experimental group
Intervention type:
Drug
Intervention name:
Anti-PD-1 monoclonal antibody
Description:
At the end of multimodal radiotherapy, immunotherapy was given within 7 days and in a
subsequent LDRT. The maximum duration is 24 months.
Arm group label:
Experimental group
Summary:
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.
Detailed description:
The patients who were clinically diagnosed advanced renal cell carcinoma with progression
after 1-2 previous systemic therapies (at least one regimen containing immune checkpoint
inhibitors, including combined VEGFR-TKI drugs), with two or more metastases at different
sites, will be evaluated by the researchers. For eligible subjects, multimodal
radiotherapy will be added to the treatment besides original immunotherapy or
combinations of immunotherapy and TKIs after adjustment. The disease control rate and
safety of this treatment will be evaluated.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
- Subjects have fully understood and voluntarily signed an informed Consent form
(ICF).
- ECOG 0-1 points.
- Major organs are functioning well.
- Willing and able to comply with study plan visits, treatment laboratory tests,
sample retention, and other procedures.
- Fertile women must voluntarily use a highly effective contraceptive method (e.g.,
oral, injectable or implantable, barrier method, spermicide and condom, or
intrauterine device) from the study period to ≥120 days after the last dose and have
negative urine or serum pregnancy test results ≤7 days prior to enrolment.
- Male patients who are not sterilized must voluntarily use highly effective
contraception during the study period until ≥120 days after the last dose.
Exclusion Criteria:
- 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.
- There is no 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.
- A history of severe drug allergy, including but not limited to antibody drugs.
- Patients with contraindications to restart immunotherapy.
- A known history of allogeneic organ transplantation and allogeneic hematopoietic
stem cell transplantation may require long-term adrenal corticosteroid therapy.
- Patients with thyroid, suprarenal, or hypopituitarism that can be controlled with
hormone replacement therapy alone, type 1 diabetes, and psoriasis or vitiligo that
do not require systemic treatment are eligible to participate in this study.
- Toxicity did not resolve after previous antitumor therapy, i.e. regression to
baseline, prescribed grade 0 to 1 (except alopecia) as defined in NCI-CTCAE 5.0, or
to the levels specified in the inclusion/exclusion criteria. Irreversible toxicity
(such as hearing loss) that could reasonably be expected not to be aggravated by the
drug under study could be included in this study.
- Have central nervous system metastases and/or cancerous meningitis.
- A known history of clinically significant liver disease.
- Accompanied by uncontrolled third space effusion requiring repeated drainage, such
as pleural effusion, ascites, pericardial effusion, etc.
- In the first study, systemic corticosteroids or other immunosuppressive drugs were
administered within 14 days prior to medication.
- Patients with any severe or uncontrolled disease.
- Have or have a suspected presence of active autoimmune diseases, including but not
limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel
disease, etc.
- Renal failure requires hemodialysis or peritoneal dialysis.
- A history of immunodeficiency, including HIV positive or other acquired, congenital
immunodeficiency diseases, or a history of organ transplantation.
- History of live attenuated vaccine vaccination within 4 weeks prior to
administration or expected live attenuated vaccine vaccination during the study
period was studied for the first time.
- People who have a history of psychotropic substance abuse and cannot abstain or have
a history of mental disorders.
- Pregnant or lactating women.
- Other severe, acute, or chronic medical or psychiatric conditions or laboratory
abnormalities, as determined by the investigator, that may increase the risks
associated with study participation or that may interfere with the interpretation of
the study results.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University
Address:
City:
Nanjing
Zip:
210000
Country:
China
Status:
Recruiting
Contact:
Last name:
Le Qu, M. D.
Phone:
15720625951
Email:
septsoul@hotmail.com
Start date:
December 15, 2023
Completion date:
September 1, 2026
Lead sponsor:
Agency:
Jinling Hospital, China
Agency class:
Other
Source:
Jinling Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06255223
