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New treatment option for Advanced RCC
Official title Gut Microbiota Modulation for Immunotherapy Resensitization in Advanced Renal Cell Carcinoma
ClinicalTrials.gov ID: NCT07611825
What this study is testing
What is Toripalimab?
Toripalimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced rcc.
Also referred to as anti-PD-1 monoclonal antibody.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The combination of immune checkpoint inhibitors (ICIs) and tyrosine kinase inhibitors (TKIs) has significantly improved clinical outcomes in patients with advanced renal cell carcinoma (RCC). However, 40%-60% of patients still develop primary or acquired resistance.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- Pathological Diagnosis and Subtype Specification Histologically confirmed metastatic renal cell carcinoma (mRCC) of either clear cell type or...
- Immunotherapy Resistance Patients must have received at least two cycles of PD-1/PD-L1 ICI therapy and demonstrated disease progression either during...
- Prior Treatment Lines and Sequence Restriction Patients must have received no more than two prior lines of systemic therapy, with no more than one...
- Lesion Requirement Patients must have at least one measurable lesion per RECIST v1.1, as assessed by the investigator or by local radiologic...
- Pre-treatment Tumor Biopsy Quality The pre-treatment tumor biopsy specimen must contain viable tumor tissue accounting for at least 75% of the total...
You likely can't join if
- \- Recent Microbiota Interference Patients are excluded if they have received systemic antibiotics within 4 weeks prior to screening, or have...
- Have a history of permanent discontinuation of immunotherapy due to immune-mediated adverse events;
- Have active or known autoimmune disease, except for type 1 diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, and vitiligo;
- Have an immunosuppressive status, defined as confirmed immunodeficiency, receipt of systemic corticosteroids at a dose equivalent to \>10 mg of...
- Planned Other Antineoplastic Treatment Patients are excluded if they require any other systemic or local antineoplastic therapy during the study...
- Active Second Malignancy Patients are excluded if they have a second active malignancy diagnosed within the preceding 2 years, with the exception of...
See the full eligibility criteria
Who can join
- Pathological Diagnosis and Subtype Specification Histologically confirmed metastatic renal cell carcinoma (mRCC) of either clear cell type or non-clear cell type, with non-clear cell histologies restricted to papillary...
- Immunotherapy Resistance Patients must have received at least two cycles of PD-1/PD-L1 ICI therapy and demonstrated disease progression either during treatment or within six months after the last dose. Progressive...
- Prior Treatment Lines and Sequence Restriction Patients must have received no more than two prior lines of systemic therapy, with no more than one line consisting of a PD-1/PD-L1 ICI. This PD-1/PD-L1 ICI based therapy...
- Lesion Requirement Patients must have at least one measurable lesion per RECIST v1.1, as assessed by the investigator or by local radiologic evaluation.
- Pre-treatment Tumor Biopsy Quality The pre-treatment tumor biopsy specimen must contain viable tumor tissue accounting for at least 75% of the total examined area.
- Prior Radiotherapy Washout Participants who have received palliative radiotherapy for non-central nervous system lesions must complete such therapy at least 2 weeks prior to the first dose of study treatment...
- Recovery from Prior Treatment Toxicity All toxicities from prior anticancer therapies must have recovered to baseline or to Grade ≤1 according to the CTCAE version 5.0, with the exception of controllable AEs such as...
- General Baseline Status Patients must be ≥18 years of age, have an Eastern Cooperative Oncology Group (ECOG) performance status \<2, an American Society of Anesthesiologists (ASA) score ≤2, and a life expectancy ≥6...
- Adequate Liver Function Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤3 × upper limit of normal (ULN), or ≤5 × ULN in patients with liver metastases. Total bilirubin ≤1.5 × ULN, except for...
- Adequate Renal Function Creatinine clearance ≥30 mL/min (Cockcroft-Gault formula) or serum creatinine ≤1.5 × ULN, and urine protein-to-creatinine ratio ≤1 mg/mg.
- Adequate Bone Marrow Function White blood cell count \>2.0 × 10⁹/L, absolute neutrophil count \>1.5 × 10⁹/L, platelet count \>100 × 10⁹/L, lymphocyte count ≥0.3 × 10⁹/L, and hemoglobin ≥90 g/L, with no blood transfusion...
- Viral Serology Patients must be negative for human immunodeficiency virus (HIV), negative for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb) with negative HBV DNA, and negative...
- Informed Consent Patients must provide written informed consent.
- Compliance Patients must be willing and able to adhere to the study protocol.
What rules you out
- \- Recent Microbiota Interference Patients are excluded if they have received systemic antibiotics within 4 weeks prior to screening, or have received any live bacterial preparations or commercial prebiotics within 2...
- Have a history of permanent discontinuation of immunotherapy due to immune-mediated adverse events;
- Have active or known autoimmune disease, except for type 1 diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, and vitiligo;
- Have an immunosuppressive status, defined as confirmed immunodeficiency, receipt of systemic corticosteroids at a dose equivalent to \>10 mg of prednisone per day or other immunosuppressive agents (excluding inhaled or...
- Planned Other Antineoplastic Treatment Patients are excluded if they require any other systemic or local antineoplastic therapy during the study period, with the exception of bisphosphonates or denosumab for the...
- Active Second Malignancy Patients are excluded if they have a second active malignancy diagnosed within the preceding 2 years, with the exception of indolent or early-stage tumors, including non-melanoma skin cancer and...
- Laboratory Abnormalities Patients are excluded if they meet any of the following criteria:
- White blood cell count \<2.0 × 10⁹/L, absolute neutrophil count \<1.5 × 10⁹/L, or platelet count \<100 × 10⁹/L;
- AST/ALT \>3 × ULN, or \>5 × ULN in patients with liver metastases, or total bilirubin \>1.5 × ULN (except for Gilbert's syndrome); ③Creatinine clearance \ 1.5 × ULN.
- Other Uncontrolled Comorbidities Patients are excluded if they have any of the following:
- Uncontrolled tumor-related pain, with painful lesions requiring palliative radiotherapy to be managed prior to enrollment;
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage more frequently than once per month, the presence of an indwelling catheter such as a PleurX® device is permitted; ③Moderate to severe...
- Other General Exclusions Patients are excluded if they meet any of the following criteria:
- Have received prior allogeneic stem cell transplantation or solid organ transplantation;
- Have active hepatitis B (HBV DNA positive), active hepatitis C (HCV RNA positive), or HIV infection;
- Have undergone major surgery within 4 weeks prior to study treatment;
- Have a history of allergy to food or antibiotics; ⑤Are pregnant, breastfeeding, or plan to conceive or father children during the study period (from pre-screening or screening visit until 120 days after the last dose)...
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.