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Anlotinib + Benmelstobart vs Surgery for Patients With Localized Renal Cell Carcinoma Scheduled to Undergo Partial Nephrectomy (ALTER-UC-011)

31. maj 2026 opdateret af: Tianjin Medical University Cancer Institute and Hospital

A Multicenter, Randomized Controlled Phase II Study of Neoadjuvant Anlotinib Hydrochloride Capsules Combined With Benmelstobart Injection Versus Surgery Alone for Localized Renal Cell Carcinoma Planned for Partial Nephrectomy

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

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

144

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
      • Beijing, Kina
        • Peking University Third Hospital
        • Kontakt:
          • Shudong Zhang
      • Changchun, Kina
        • Jilin Provincial Cancer Hospital
        • Kontakt:
          • Changdong Zhou
      • Changsha, Kina
        • Hunan Provincial Cancer Hospital
        • Kontakt:
          • Xie Yu
      • Hangzhou, Kina
        • The first Affiliated Hospital, Zhejiang University School of Medicine
        • Kontakt:
          • Dan Xia
      • Kunming, Kina
        • Yunnan Provincial Cancer Hospital
        • Kontakt:
          • Yong Yang
      • Nanjing, Kina
        • Nanjing Drum Tower Hospital
        • Kontakt:
          • Hongqian Guo
      • Nanning, Kina
        • The First Affiliated Hospital of Guangxi Medical University
        • Kontakt:
          • Jiwen Chen
      • Qingdao, Kina
        • The Affiliated Hospital of Qingdao University
        • Kontakt:
          • Ke Wang
      • Shanghai, Kina
        • Huadong Hospital Affiliated to Fudan University
        • Kontakt:
      • Shenyang, Kina
        • Liaoning Provincial Cancer Hospital
        • Kontakt:
          • Bing Hu
      • Taiyuan, Kina
        • Shanxi Province Cancer Hospital
        • Kontakt:
          • Xuebing Han
      • Tianjin, Kina
        • Tianjin Medical University Cancer Institute and Hospital
        • Kontakt:
      • Wuhan, Kina
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Kontakt:
          • Xiaoping Zhang
      • Zhengzhou, Kina
        • The first affiliated hospital of Zhengzhou university
        • Kontakt:
          • Xuepei Zhang

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Aged between 18 and 75 years, inclusive.
  2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  3. Subjects with newly diagnosed cT1bN0M0 renal cell carcinoma (RCC) scheduled to undergo partial nephrectomy.
  4. Have at least one measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  5. No prior systemic therapy for renal cell carcinoma, including but not limited to targeted therapy, immunotherapy, investigational therapy, or hormone therapy.

Exclusion Criteria:

  1. Subjects with a solitary kidney tumor.
  2. Subjects with bilateral renal tumors or unilateral multiple renal tumors (n ≥ 2).
  3. Subjects with hereditary or familial renal tumors (e.g., von Hippel-Lindau [VHL] disease).
  4. Subjects with a prior history of renal transplantation.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Anlotinib + Benmelstobart
Anlotinib capsules 12 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21)； Benmelstobart 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle
Medicin: Anlotinib hydrochloride + Benmelstobart + Partial nephrectomy
Patients receive neoadjuvant therapy with oral anlotinib hydrochloride capsules and intravenous benmelstobart injection, followed by partial nephrectomy for localized renal cell carcinoma.
Aktiv komparator: Upfront partial nephrectomy (standard care)
Patients receive upfront partial nephrectomy
Procedure: Partial nephrectomy
Patients receive upfront partial nephrectomy without neoadjuvant therapy, as the standard treatment for localized renal cell carcinoma.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pentafecta Achievement
Tidsramme: Through study completion, an average of 1 year

It includes: negative surgical margin, warm ischemia time (WIT) ≤ 25 minutes, no perioperative complications, estimated glomerular filtration rate (eGFR) preservation ≥ 90% at 9-12 months postoperatively, and no increase in chronic kidney disease (CKD) stage at 9-12 months postoperatively.

The eGFR preservation rate is calculated as the percentage of the postoperative eGFR relative to the preoperative baseline eGFR.

An increase in CKD stage is defined as progression to Stage III, IV, or V; progression from Stage I to Stage II is not considered an increase in CKD stage.
Through study completion, an average of 1 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Primary tumor partial response (PR) rate in the experimental arm
Tidsramme: Through study completion, an average of 1 year
Through study completion, an average of 1 year
Safety
Tidsramme: Through study completion, an average of 2 years
Number of participants with treatment-related adverse events as assessed by CTCAE 6.0 To further describe safety and assess toxicities encountered with the use of the proposed treatment regimen in participants
Through study completion, an average of 2 years
2-year DFS Rate
Tidsramme: 2-years
2-year Disease-Free Survival Rate
2-years
R.E.N.A.L. score changes in the experimental group
Tidsramme: Through study completion, an average of 1 year

The R.E.N.A.L. Nephrometry Score is a 4-12 point anatomical classification system for renal tumors, with each letter representing a key feature scored as 1, 2, or 3 points, as follows:

(R) Radius (Maximum tumor diameter, cm)； (E) Exophytic/endophytic properties (Tumor growth pattern)； (N) Nearness to the collecting system or renal sinus (Tumor distance to collecting system/renal sinus, mm)； (A) Anterior/posterior location； (L) Location relative to the polar line (Relationship to renal polar line; suffix (h) is added if the tumor is adjacent to major renal artery or vein)
Through study completion, an average of 1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

31. maj 2026

Primær færdiggørelse (Anslået)

31. december 2028

Studieafslutning (Anslået)

31. december 2029

Datoer for studieregistrering

Først indsendt

20. maj 2026

Først indsendt, der opfyldte QC-kriterier

31. maj 2026

Først opslået (Faktiske)

4. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ALTER-UC-011 (Anden identifikator: Same as current)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Nyrecellekarcinom (RCC)

Kliniske forsøg med Anlotinib hydrochloride + Benmelstobart + Partial nephrectomy

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Zimbabwe

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner