Pucotenlimab Combination With Vorolanib as Neoadjuvant Therapy for ccRCC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorSun Yat-sen University
About this trial
Through the neoadjuvant treatment with a combination of Pucotenlimab and Vorolanib, it enabled the successful and safe implementation of partial nephrectomy in patients with localized renal cancer, who had indications for nephron-sparing surgery but faced considerable difficulty in preserving the kidney (T1b with an endophytic component ≥75% or T2)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntarily sign a written informed consent form (ICF).
Age at the time of enrollment is between 18 years old and 85 years old, regardless of gender.
The physical fitness score of the Eastern Cooperative Oncology Group (ECOG) in the United States is 0 or 1.
Expected survival period ≥ 3 months.
Disqualifiers
Pregnant or lactating women.
Any past or current illness, treatment, or laboratory test abnormalities may confuse the research results, affect the full participation of the subjects in the study, or participation in the study may not be in the best interests of the subjects.
Trial design
Design model
Single group
Treatments tested in this trial
Pucotenlimab combination with Vorolanib
Drug3.7.1 Vorolanib Vorolanib 200mg PO QD, taken with or without food. 3.7.2 Pucotenlimab Intravenous infusion of 200mg of Pucotenlimab (injection), once every 3 weeks, as one treatment cycle.
Treatment groups
21 Participants
are divided into 1 treatment groupGroup A: Pucotenlimab combination with Vorolanib as neoadjuvant therapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective Response Rate (ORR) based on RECIST 1.1 criteria.
Time frame
Evaluation at the end of Cycle 2 or Cycle 4 (each cycle is 21 days) of Pucotenlimab treatmentSponsors and contacts
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Source ClinicalTrials.gov