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

NCT06255223 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 2024DZKY-018-01
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Renal Cell Carcinoma; Radiotherapy; Immune Checkpoint Inhibitor

Keywords

RCC; Multimodal radiotherapy

Outcome Measures

Primary Outcomes (2)

• Disease control rate (DCR)

  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).

  Up to 1 year

• Incidence of adverse events

  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.

  Up to 1 year

Secondary Outcomes (5)

• Progression-free survival (PFS)

  Up to 1 year

• Objective response rate (ORR) (partial response or complete response)

  Up to 1 year

• Overall survival (OS)

  Up to 1 year

• Abscopal effects

  1 year

• Change of lymphocyte subsets and tumor-associated macrophages (TAMs)

  1 year

Study Arms (1)

Experimental group

EXPERIMENTAL

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

Radiation: High-dose Radiotherapy (HDRT); Radiation: Low-dose Radiotherapy (LDRT); Drug: Anti-PD-1 monoclonal antibody

Interventions

High-dose Radiotherapy (HDRT) RADIATION

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

Also known as: Stereotactic Body Radiation Therapy, SBRT, Stereotactic Ablative Body Radiation Therapy, SABR

Experimental group

Low-dose Radiotherapy (LDRT) RADIATION

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.

Experimental group

Anti-PD-1 monoclonal antibody DRUG

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

Experimental group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.
• 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.

Sponsors & Collaborators

• Jinling Hospital, China: lead

Study Sites (1)

Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Radiotherapy; Radiosurgery; spartalizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Le Qu, M. D.

CONTACT

15720625951; septsoul@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate chief urologist

Study Record Dates

• First Submitted: February 3, 2024
• First Posted: February 13, 2024
• Study Start: December 15, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-08

Locations

CN (1)