Status and phase
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Treatments
About
The goal of this prospective, multicenter, single-arm clinical study is to evaluate the efficacy and safety of toripalimab in combination with axitinib for postoperative adjuvant therapy for non-clear renal cell carcinoma with high-risk recurrence factors.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Age 18-75 years old
Participants with histologically confirmed non-clear renal cell carcinoma except clear cell RCC, chromophobe RCC and eosinophilic RCC, and must meet any of the following conditions:
Patients who have completely resected the primary tumor (partial or radical nephrectomy), and M1 NED patients who have completely resected solid, isolated soft tissue metastases.
Patients who have completely removed the renal tumor. The nephrectomy must be performed ≥ 3 weeks but ≤ 12 weeks before randomization. Partial nephrectomy and renal tumor enucleation are permitted;
Patients must have no clinical or radiographic evidence of macroscopic residual lesions or distant metastasis (M0) after surgery. M1 participants must have no evidence of disease (M1 NED);
ECOG performance status 0-1 ;
Patients must have not received systemic therapy for renal tumors;
Adequate hematopoiesis and organ function:
Signed informed consent form;
Patients and/or their partner are willing to use highly effective forms of contraception and to continue its use 3 months after the last dose of drugs.
Ability and capacity to comply with study and follow-up procedures.
Exclusion criteria
Clear cell RCC, chromophobe RCC and eosinophilic RCC;
Previous anti-tumor immunotherapy, including but not limited to cytokines (IL-2, IFN-α, etc.) and antibody drugs (anti-PD-1, PD-L1, or CTLA-4 antibodies, etc.)
Previous drug therapy targeting VEGF, VEGFR, or mTOR;
Have participated in or are currently participating in an investigational drug trial within 4 weeks; major surgery performed within 4 weeks prior to randomization;
Receive traditional Chinese medicines or proprietary Chinese medicine, adrenocortical hormone or other immunosuppressant systemic therapy within 2 weeks before enrollment; People who > 10 mg of prednisone or equivalent inhalers daily but have no active autoimmune disease may participate in this study;
Toxicity has not been relieved after previous antineoplastic therapy; Irreversible toxicities (e.g., hearing loss) that are reasonably expected not to be aggravated by the study drug may participate in this study;
Other malignancies that have progressed or require treatment in 5 years (excluding adequately treated basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, superficial bladder cancer, breast, cervix, or prostate carcinoma in situ);
History of central nervous system (CNS) metastases or CNS metastases on baseline imaging (MRI or CT) within 30 days prior to the first trial administration;
Hypertension that cannot be controlled by medications (blood pressure 150/100 mmHg despite optimal medical therapy)
Evidence of following cardiovascular disease within 6 months:
QT interval (QTc) corrected with heart rate ≥500 msec (Bazett's formula)
History of active or other severe bleeding within 30 days, and have haemoptysis within 6 weeks prior to randomization;
Deep vein thrombosis or pulmonary embolism within 6 months;
Clinically significant gastrointestinal (GI) abnormalities, including:
History of organ transplantation may require long-term adrenocortical hormone therapy;
Previous or current presence of (noninfectious) pneumonia/interstitial lung disease requiring adrenocortical hormone therapy
Active infection requiring systemic treatment, human immunodeficiency virus (HIV) infection (known HIV antibody positive), active HBV or HCV infection;
Have received a live vaccine within 30 days prior to enrollment;
History of severe drug allergy;
Known history of psychiatric illness or substance abuse;
The presence of unhealed wounds;
Taken within 7 days prior to enrollment or expected to take concomitant treatment with potent CYP3A4/5 inhibitors and CYP3A4/5 inducers ;
Subject has a history or current evidence of any disease, treatment, or laboratory abnormality that may confound the trial results, interfere with the subject's participation in the full trial, or is not in the best interest of the subject to participate in the trial, in the judgment of the investigator.
Primary purpose
Allocation
Interventional model
Masking
30 participants in 1 patient group
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Central trial contact
shun zhang
Data sourced from clinicaltrials.gov
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