Precision treatment for kidney cancer based on proteomic analysis

Proteomic Guided First-line Precision Treatment of Renal Clear Cell Carcinoma: a Single-center, Prospective, Phase II Umbrella Clinical Study

This study is testing personalized treatment options for kidney cancer patients by grouping them based on their tumor's characteristics to see which combination of drugs works best for them.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fudan University (other)
• Drugs / interventions: chemotherapy, immunotherapy, Radiation, prednisone, tislelizumab, anlotinib
• Locations: 1 site (Shanghai)
• Trial ID: NCT06211790 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to provide personalized treatment for patients with renal clear cell carcinoma by categorizing them into three distinct subtypes based on their tumor's molecular characteristics. Utilizing the MSKCC Prognostic Model and IMDC criteria, patients will be assigned to one of three treatment groups receiving either anlotinib, anlotinib combined with everolimus, or anlotinib combined with tislelizumab. The study will evaluate the efficacy and safety of these treatment regimens in patients who have not received prior systemic therapy. By leveraging proteomic analysis of tissue samples, the trial seeks to enhance precision medicine in the management of kidney cancer.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 75 with unresectable or metastatic clear cell carcinoma of the kidney and available tissue samples for testing.

Not a fit: Patients with prior systemic treatment for their kidney cancer or those with significant organ dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective and tailored treatment options for patients with renal clear cell carcinoma.

How similar studies have performed: While this approach is innovative, similar studies utilizing proteomic-guided therapies have shown promise in other cancer types, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

Patients who meet the following criteria are eligible to participate in the trial:

* Male or female aged 18 and ≤ 75;
* Histologically or cytologically confirmed unresectable or metastatic clear cell carcinoma of the kidney, which may contain sarcomatoid lesions;
* At least one measurable target lesion at the time of enrollment according to RECIST1.1(Response Evaluation Criteria In Solid Tumors) standards;
* Tissue samples are available for testing;
* No previous systemic treatment for the disease;
* ECOG(Eastern Cooperative Oncology Group) PS(performance status) 0-1;
* Normal function of major organs (14 days prior to enrollment), i.e. meeting the following criteria:

  1. Blood routine examination criteria should be met (no blood transfusion and no granulocyte colony were received within 14 days before enrollment Stimulator therapy) :

     HB 90 g/L or higher The ANC(absolute neutrophil count) acuity 1.5 x 109 / L PLT(platelet count) acuity 100 x 109 / L
  2. No functional organic disease, the following criteria should be met:

Serum creatinine (Cr) ≤ 1.5× upper limit of normal (ULN) or creatinine clearance ≥40 mL/min T-bil ≤1.5×ULN upper limit of normal value ALT(Alanine transaminase) and AST≤2.5×ULN If liver metastasis, ALT and AST≤5×ULN

* Expected survival ≥3 months;
* Patients with potential fertility need to use contraception during the study period;
* Patients who volunteered to participate in this study and signed informed consent.

Exclusion Criteria:

Patients with any of the following conditions will be excluded from the trial:

1. Patients who have received the following medical interventions in the four weeks prior to treatment:

   * Radiation, surgery, chemotherapy, immunotherapy or molecular targeted therapy for tumors
   * To participate in other clinical studies of drug therapy
   * Live attenuated vaccine history
2. Previously received PD-1/PD-L1 monoclonal antibody, CTLA-4 antibody(cytolytic T lymphocyte-associated antigen) or other immunotherapy;
3. Previously received targeted therapy;
4. Definite brain/meningeal metastasis;
5. Patients who received systemic treatment with corticosteroids (\> 10 mg daily prednisone or equivalent) or other immunosuppressive drugs within 14 days prior to enrollment;
6. Any active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism), or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
7. Severe disturbances (CTCAE, Common Terminology Criteria for Adverse Events\> Class 2) occurred within 4 weeks prior to administration of the study drug;Baseline chest imaging suggests active pulmonary inflammation, signs and symptoms of infection (unexplained fever \>38.5 degrees) within 14 days prior to first use of the study drug, or the need for oral or intravenous antibiotic treatment;
8. Patients with clinically significant bleeding symptoms or definite bleeding tendency within 3 months prior to treatment, or with arteriovenous thrombosis events occurring within 6 months prior to treatment;
9. Active cardiovascular disease, such as myocardial infarction, severe/unstable angina, or New York Heart Association Class III or IV congestive heart failure, was present in the 6 months prior to treatment.
10. Have had other malignancies in the past 5 years (basal cell carcinoma of the skin that has been cured, except carcinoma in situ of the breast and carcinoma in situ of the cervix);
11. Have multiple factors that affect oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction);
12. Known to have active tuberculosis;
13. HIV antibody positive, active hepatitis B or C (HBV, HCV);
14. Is known to be allergic to the investigational drug or any excipients thereof, or has had a severe allergic reaction to other monoclonal antibodies;
15. Pregnant or lactating women and women of childbearing age do not take reliable contraceptive measures;
16. In the investigator's judgment, there is a concomitant medical condition (such as poorly controlled high blood pressure, severe diabetes, neurological or psychiatric illness, etc.) or any other condition that seriously endangers the subject's safety, may confuse the study results, or may interfere with the subject's completion of the study.

Where this trial is running

Shanghai

• Fudan University Shanghai Cancer Center — Shanghai, China (RECRUITING)

Study contacts

• Study coordinator: dingwei ye

Conditions: Kidney Cancer, Renal Cell Carcinoma, Renal Clear Cell Carcinoma