Preoperative Therapy of Super-selective Tumor Artery Embolization Combined With Toripalimab and Axitinib in Advanced RCC

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTianjin Medical University Second Hospital

About this trial

This is a phase II study to determine the efficacy and safety of Super-selective tumor artery embolization combined with toripalimab and axitinib as treatment for patients with the advanced kidney cancer . Further evaluate whether the treatment plan is beneficial to the patient's operation. Patients will undergo super-selective embolization of the feeding arteries to the renal tumour one week prior to drug therapy, followed by toripalimab administered every three weeks for three to four consecutive cycles combined with axitinib administered for four consecutive cycles in the preoperative and patients need to continue taking the drug for a year after surgery

Eligibility criteria

Qualifiers

Willing and able to provide written informed consent

Age ≥ 18 years

cT2N0M0 with Grade 4 or sarcomatoid feature;

cT3-4N0M0;

Disqualifiers

Prior receipt of radiotherapy, chemotherapy, long-term or high-dose corticosteroid therapy, surgery, or molecular targeted therapy

Subjects with a history of or concurrent other malignancies (except those controllable and not affecting 2-year survival)

Prior treatment with other PD-1/PD-L1 therapies; Known history of allergy to macromolecular protein preparations or any known PD-1 component

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; Subjects with vitiligo or childhood asthma that has achieved complete remission without requiring any intervention in adulthood may be included; subjects requiring medical intervention with bronchodilators for asthma are excluded);

Trial design

Treatments tested in this trial

  • Toripalimab and axitinib

Treatment groups

40 Participants
are divided into 1 treatment group