Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunomodulating Agents

Immunoglobulins

Immunologic Factors

For eligible subjects, multimodal radiotherapy will be added to the treatment besides original immunotherapy or combinations of immunotherapy and TKIs after adjustment.

SBRT was adopted, and radiotherapy plan was made according to the location and size of lesions (total dose 20-70Gy, 5-12Gy every time).

High-dose Radiotherapy (HDRT)

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.

Low-dose Radiotherapy (LDRT)

At the end of multimodal radiotherapy, immunotherapy was given within 7 days and in a subsequent LDRT. The maximum duration is 24 months.

Anti-PD-1 monoclonal antibody

Le Qu, M. D.

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.

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.

A Study of Multimodal Radiotherapy for Renal Cell Carcinoma Progressed After Prior Immunotherapy

An Open-label, Single-arm Study to Evaluate the Efficacy and Safety of Multimodal Radiotherapy in the Treatment of Renal Cell Carcinoma Progressed After Prior Immunotherapy

After completing the full course of radiotherapy, the patients underwent periodic imaging evaluation. Tumor imaging evaluations within 48 weeks should be performed every 6 weeks (±7 days) and every 12 weeks (±7 days) after 48 weeks until disease progression, loss of follow-up, death, withdrawal of study informed consent, subject initiation of other antitumor therapy, or study termination. DCR was evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST v 1.1).

Adverse events according to Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). The patients must be on the trial for at least 8 weeks. Adverse events must be attributable to radiation therapy or immunotherapy.

After completing the full course of radiotherapy, the patients underwent periodic imaging evaluation. Tumor imaging evaluations within 48 weeks should be performed every 6 weeks (±7 days) and every 12 weeks (±7 days) after 48 weeks until disease progression, loss of follow-up, death, withdrawal of study informed consent, subject initiation of other antitumor therapy, or study termination. PFS was evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST v 1.1).

After completing the full course of radiotherapy, the patients underwent periodic imaging evaluation. Tumor imaging evaluations within 48 weeks should be performed every 6 weeks (±7 days) and every 12 weeks (±7 days) after 48 weeks until disease progression, loss of follow-up, death, withdrawal of study informed consent, subject initiation of other antitumor therapy, or study termination. ORR was evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST v 1.1).

After completing the full course of radiotherapy, patients were followed for one year until the last visit or death. OS was measured based on data collected through professional procedures.

When making a radiotherapy plan, identify one or more LDRT lesions to be used for puncture. After the completion of the full course of radiotherapy, the predetermined lesions were punctured, and the obtained specimens were analyzed by pathological biopsy and immunohistochemistry to evaluate the changes of tumor microenvironment. At the same time, the patient's blood was extracted and the relevant cytokines were detected for analysis.

When making a radiotherapy plan, identify one or more LDRT lesions to be used for puncture. After the completion of the full course of radiotherapy, the predetermined lesions were punctured, and the obtained specimens were analyzed by pathological biopsy and immunohistochemistry to evaluate the changes of immune cells through the markers in tumor microenvironment. At the same time, the patient's blood was extracted and the numbers of relevant cells were detected. The changes of CD8+ T cells, CD4+ T cells, Treg, phenotype of TAMs and DCs were evaluated.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of Multimodal Radiotherapy for Renal Cell Carcinoma Progressed After Prior Immunotherapy	NCT06255223	Renal Cell Carc... Radiotherapy Immune Checkpoi...	High-dose Radio... Low-dose Radiot... Anti-PD-1 monoc...	18 Years - 80 Years	Jinling Hospital, China
A Study of Multimodal Radiotherapy for Renal Cell Carcinoma Progressed After Prior Immunotherapy	NCT06255223	Renal Cell Carc... Radiotherapy Immune Checkpoi...	High-dose Radio... Low-dose Radiot... Anti-PD-1 monoc...	18 Years - 80 Years	Jinling Hospital, China

Spots Global Cancer Trial Database for multimodal radiotherapy