SABR Combined With Targeted Therapy and Anti-PD-1 for Recurrent or Metastatic Renal Cancer (COSTAR)

Cohort Study of SABR Combined With Targeted Therapy and Anti-PD-1 Versus Targeted Therapy and Anti-PD-1 for Recurrent or Metastatic Renal Cell Carcinoma Patients

Renal cancer ranks seventh in incidence among men and sixth among women in the Beijing area, with Peking University First Hospital treating over 1,000 kidney cancer patients annually. Once recurrence or metastasis occurs, the prognosis is poor, with median progression times of 1-2 years after first-line systemic therapy (targeted therapy combined with immunotherapy). Enhancing local control of lesions is key to improving overall survival. Combining local radiotherapy with systemic treatment may be one approach to address this issue. Currently, Stereotactic Ablative Radiotherapy (SABR) enables precise tumor ablation and can activate the body's immune response. Studies show that the one-year local control rate after SABR exceeds 90%. Preliminary research by the applicant has shown that the combination of drug therapy and SABR for recurrent metastatic renal cancer can extend progression-free survival beyond two years, with earlier intervention leading to more significant survival improvements. This study aims to evaluate the efficacy and safety of combining SABR with targeted and immunotherapy for recurrent metastatic renal cancer through a multicenter, bidirectional cohort design, exploring new therapeutic strategies.

Study Overview

• Status: Recruiting
• Conditions: Recurrent Renal Cell Cancer; Radiation Therapy; Metastatic Renal Cancer
• Intervention / Treatment: Radiation: Radiation therapy

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Mingwei Ma, M.D.; Phone Number: +86-15810160120; Email: dr.mingweima@stu.pku.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100034
      • Recruiting
      • Peking University First Hospital
      • Contact: Mingwei Ma, M.D.; Phone Number: +86-15810160120; Email: dr.mingweima@stu.pku.edu.cn
    • Beijing, Beijing, China, 100091
      • Recruiting
      • Peking University Third Hospital
      • Contact: Hao Wang, M.D.; Phone Number: +86-18611207267; Email: hhbysy@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with histologically confirmed renal cancer; diagnosed with recurrent or metastatic renal cancer via PET/CT or other whole-body imaging.

Description

Inclusion Criteria:

• Patients with histologically confirmed renal cancer; diagnosed with recurrent or metastatic renal cancer via PET/CT or other whole-body imaging.
• Evaluated by the radiation oncology and imaging departments as having at least one lesion amenable to radiation therapy.
• Planning to undergo or currently receiving first-line or second-line targeted therapy combined with immunotherapy.
• Voluntarily agrees to participate in the study and signs an informed consent form.
• Male or female, aged ≥18 years (inclusive).
• Expected survival of ≥12 weeks.
• At least one measurable lesion as per the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
• European Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Adequate cardiac, bone marrow, liver, and renal function.
• Willing and able to comply with the study procedures and follow-up schedule.

Exclusion Criteria:

• Extensive, multiple metastases;
• Presence of central nervous system metastases and/or carcinomatous meningitis.
• Toxicity from previous treatments not yet recovered to grade 0-1 (excluding grade 2 alopecia);
• Other severe, uncontrollable co-morbid conditions that could affect protocol compliance or confound interpretation of results, including active opportunistic or severe progressive infections, uncontrolled diabetes, uncontrolled hypertension, cardiovascular diseases (defined as New York Heart Association Class III or IV heart failure, second-degree or higher heart block, myocardial infarction within the last 12 months, unstable arrhythmias or angina, stroke within the last 6 months), or pulmonary diseases (interstitial pneumonia, obstructive pulmonary disease, and symptomatic bronchospasm history), deep vein thrombosis or pulmonary embolism within the last 6 months;
• Diagnosed with other malignancies within 5 years prior to enrollment, except:
• Localized low-risk prostate cancer (defined as stage ≤T2b, Gleason score ≤7, and PSA ≤20ng/mL at diagnosis, who have undergone curative treatment with no recurrence of prostate-specific antigen);
• Malignancies treated with a curative intent that are considered cured, including but not limited to adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated with surgery;
• Pregnant or breastfeeding women;
• Positive HIV test result;
• Active hepatitis B or C infection;
• Active tuberculosis;
• Any other conditions, metabolic abnormalities, physical examination or laboratory findings that in the investigator's judgment might indicate an unsuitability for the study drug, could interfere with the interpretation of study results, or place the patient at high risk if they participate in the study;
• Estimated insufficient compliance with the clinical study.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
RT group; In conjunction with targeted and immunotherapy, administer radiation therapy to achieve as complete coverage as possible of all identifiable primary and metastatic lesions.	Radiation: Radiation therapy; Administer radiation therapy to achieve as complete coverage as possible of all identifiable primary and metastatic lesions in conjunction with targeted and immunotherapy
Control group; Targeted and immunotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival 2, PFS2	Progression Free Survival 2 (PFS2) is defined as the time from the start of treatment to the point where, despite the emergence of new lesions and continuation of the original systemic therapy, local radiotherapy is used to intervene on new lesions. Subsequently, due to the emergence of additional new lesions or progression of existing lesions, a change in systemic therapy becomes necessary. Alternatively, it also includes situations where a new lesion appears and cannot be treated with radiotherapy, necessitating a change in the original systemic therapy plan.	2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival 1, PFS1	Defined as the time from the start of treatment to the first progression.	2 year
Overall survival, OS	Defined as the time from the start of treatment to death.	2 year
Objective response rate，ORR	Defined as CR (Complete Response) + PR (Partial Response), representing the best response achieved at any time.	six months.
Disease control rate，DCR	Defined as CR + PR + SD (Stable Disease), maintained for at least six months.	six months.
Adverse Reactions	Evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 to assess treatment-related adverse reactions.	2 year

Collaborators and Investigators

• Sponsor: Peking University First Hospital
• Collaborators: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: August 24, 2024
• First Submitted That Met QC Criteria: September 1, 2024
• First Posted (Actual): September 3, 2024

Study Record Updates

• Last Update Posted (Actual): September 3, 2024
• Last Update Submitted That Met QC Criteria: September 1, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: SBRT; Metastatic Renal Cancer; Recurrent Renal Cell Cancer
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Disease Attributes; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Neoplasms; Carcinoma, Renal Cell; Recurrence
• Other Study ID Numbers: COSTAR-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No