Anlotinib + Benmelstobart vs Surgery for Patients With Localized Renal Cell Carcinoma Scheduled to Undergo Partial Nephrectomy

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTianjin Medical University Cancer Institute and Hospital

About this trial

Evaluation of long-term renal function improvement, surgical safety, as well as efficacy and safety of preoperative anlotinib hydrochloride capsules combined with benmelstobart injection versus surgery in patients with localized renal cell carcinoma undergoing partial nephrectomy

Eligibility criteria

Qualifiers

Aged between 18 and 75 years, inclusive.

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Subjects with newly diagnosed cT1bN0M0 renal cell carcinoma (RCC) scheduled to undergo partial nephrectomy.

Have at least one measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Disqualifiers

Subjects with a solitary kidney tumor.

Subjects with bilateral renal tumors or unilateral multiple renal tumors (n ≥ 2).

Subjects with hereditary or familial renal tumors (e.g., von Hippel-Lindau [VHL] disease).

Subjects with a prior history of renal transplantation.

Trial design

Treatments tested in this trial

  • Anlotinib hydrochloride + Benmelstobart + Partial nephrectomy
  • Partial nephrectomy

Treatment groups

144 Participants
are divided into 2 treatment groups