Status:
RECRUITING
Perioperative TORIPALIMAB Plus LENVATINIB in Patients With Renal Cell Carcinoma Undergoing Nephrectomy (PLUTO)
Lead Sponsor:
Jinling Hospital, China
Conditions:
Renal Cell Carcinoma (RCC)
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The PLUTO-trial is a single-center, open-label, phase II trial investigating Toripalimab plus Lenvatinib in patients with multi-stage clear-cell renal cell carcinoma. In this trial, patients will be e...
Eligibility Criteria
Inclusion
- Have fully understood and voluntarily signed the informed consent Form (ICF);
- Age: 18-80 years old (at the time of signing the informed consent); Both male and female; ECOG PS score: 0-1;
- RCC with clear cell component confirmed by histology or cytopathology, including locally advanced RCC with clear cell component;
- ECOG 0-1 points
- T1b-T2bN0M0, T3a-4N0M0, TanyN1M0 or M1RCC diagnosed by imaging at initial diagnosis:
- Cohort 1: T1b-T2bN0M0 RCC;
- Cohort 2: T3a-4N0M0 or TanyN1M0 RCC;
- Cohort 3: M1 RCC undergoing cytoreductive nephrectomy.
- Radical nephrectomy or partial nephrectomy or renal tumor enucleation was decided after the clinician made the treatment plan and communicated with the patient;
- Willingness and ability to comply with planned visits, therapeutic laboratory testing, and other procedures.
Exclusion
- Signs of tumor metastasis involving the central nervous system;
- History of malignant tumors other than the study disease within the previous 5 years, with the exception of malignant tumors that can be expected to be cured with treatment (including but not limited to adequately treated thyroid cancer, carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated with radical surgery);
- Prior to participating in the study, patients had received other systemic treatment drugs, including targeted drugs, immunotherapy drugs and their combination regimens, or local anti-tumor therapy, or received investigational drugs or device therapy;
- Underwent major surgery (judged by the investigator) within 4 weeks before the first trial dose, were recovering, or were unable to undergo baseline puncture;
- History of severe drug allergy, including but not limited to antibody drugs;
- patients with contraindications to immunotherapy restart, including but not limited to:
- Grade 2-4 immune myocarditis;
- Severe grade 4 proteinuria;
- Severe or life-threatening grade 4 immune hepatitis;
- Severe grade 3-4 immune pneumonitis;
- Severe inflammatory arthritis that significantly affects daily life or quality of life;
- Severe neurological toxicity:
- Myasthenia gravis grade 2-4;
- Guillain-Barre syndrome (GBS) or transverse myelitis of any grade;
- Grade 2-4 encephalitis;
- Severe or life-threatening grade 3-4 pancreatitis;
- Severe or life-threatening bullous disease (grade 3-4);
- Severe grade 3-4 uveitis or episcleritis;
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation or long-term corticosteroid therapy. Patients with thyroid, suprarenal or hypopituitarism that could be controlled only with hormone replacement therapy, type 1 diabetes mellitus, psoriasis or vitiligo without systemic treatment, etc., were eligible to participate in the study.
- Non-resolution of toxicity after previous antineoplastic therapy, i.e., resolution to baseline, NCI-CTCAE 5.0 grade 0-1 (excluding alopecia), or inclusion/exclusion criteria. Irreversible toxicities (e.g., hearing loss) that would not reasonably be expected to be exacerbated by the study drug can be included in the study;
- Known history of clinically significant liver disease, including active viral hepatitis (hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HbcAb) positive, HBV DNA\>10000 copies /mL or \>2000 IU/mL; Hepatitis C virus (HCV) antibody positive and HCV RNA positive\], or other active hepatitis, clinically significant moderate to severe cirrhosis;
- Patients with uncontrolled third space effusion requiring repeated drainage, such as pleural effusion, ascites, pericardial effusion, etc. (Patients who do not need drainage of effusion or stop drainage for 3 days without significant increase in effusion can be enrolled);
- Receiving a systemic corticosteroid (prednisone \> 10mg/ day or equivalent) or other immunosuppressive medication within 14 days before the first study medication;
- Patients with any severe and/or uncontrolled disease, including:
- Hypertension that is not well controlled by antihypertensive medication (systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg);
- Unstable angina pectoris or myocardial infarction, coronary artery bypass grafting or stent implantation within 6 months before study medication;
- Grade I or above myocardial ischemia or myocardial infarction, arrhythmia (including QTc≥480ms) and ≥ grade 2 congestive heart failure (New York Heart Association (NYHA) classification); Degree Ⅱ or above heart block; Left ventricular ejection fraction (LVEF) \< 50%;
- Poorly controlled diabetes (fasting blood glucose \> 10 mmol/L);
- Patients with urinary protein ≥++ and confirmed 24-hour urinary protein \> 1.0g;
- Severe active or uncontrolled infection;
- Patients with or suspected to have active autoimmune diseases, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc.;
- Renal failure requiring hemodialysis or peritoneal dialysis;
- Patients with a history of immunodeficiency, including HIV positive patients, other acquired immunodeficiency diseases, congenital immunodeficiency diseases, or organ transplantation history;
- History of live attenuated vaccine inoculation within 4 weeks before the first study drug or the expected vaccination during the study period;
- History of psychiatric drug abuse and can not quit or have a history of mental disorders;
- The presence of any other severe, acute or chronic medical disease or mental illness or laboratory abnormality, as judged by the investigator, that may increase the risk associated with participation in the study or that may interfere with the interpretation of the results of the study.
Key Trial Info
Start Date :
December 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT06114940
Start Date
December 20 2022
End Date
December 31 2027
Last Update
October 21 2025
Active Locations (1)
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1
Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China
Nanjing, Jiangsu, China, 210000