Actively Recruiting

Phase 2
Age: 18Years - 85Years
All Genders
NCT07386158

Pucotenlimab Combination With Vorolanib as Neoadjuvant Therapy for ccRCC

Led by Sun Yat-sen University · Updated on 2026-02-04

21

Participants Needed

1

Research Sites

77 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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)

CONDITIONS

Official Title

Pucotenlimab Combination With Vorolanib as Neoadjuvant Therapy for ccRCC

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent
  • Age between 18 and 85 years, any gender
  • ECOG physical fitness score of 0 or 1
  • Expected survival of at least 3 months
  • Confirmed renal clear cell carcinoma or mostly clear cell carcinoma by biopsy
  • Willingness to undergo kidney preservation surgery
  • Healthy kidney function with GFR less than 60 ml/min by renal imaging
  • Tumor size and location indicating difficult but possible kidney preservation surgery (4-7 cm near renal hilum or tumors larger than 7 cm)
  • At least one measurable lesion suitable for accurate repeated measurements
  • Good organ function and laboratory results meeting hematology, liver, and coagulation criteria
  • Willing and able to comply with study visits, treatments, and tests
Not Eligible

You will not qualify if you...

  • Renal vein cancer thrombus
  • Diffuse tumor growth without clear boundary with normal kidney tissue
  • Poor general condition or unable to tolerate general anesthesia
  • Serious uncontrolled cardiovascular or cerebrovascular diseases
  • Uncontrolled hypertension or diabetes
  • Long-term use of immunosuppressants post-organ transplantation
  • Current use of immunosuppressive drugs
  • Active infection or fever
  • Diagnosis of T-cell lymphoma or myeloma
  • Concurrent malignant tumors, recent treatment for other tumors, or history of other cancers within 6 months
  • Metastatic renal cell carcinoma
  • Recent use (within 14 days) of Chinese herbal medicine or immunomodulatory drugs with anti-tumor effects
  • Systematic treatment with certain immune agents (except local treatment for pleural effusion)
  • Active or recurrent autoimmune diseases except specified stable conditions
  • Participation in another interventional clinical study
  • History of mental illness, drug abuse, alcoholism
  • Pregnancy or breastfeeding
  • Any illness or condition that could interfere with study participation or results

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Sun Yat-sen University Cancer Center

Guangzhou, Other (Non U.s.), China, 0755

Actively Recruiting

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Research Team

Z

Zhiling Zhang, M.D

CONTACT

Y

Yulu Peng, M.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Pucotenlimab Combination With Vorolanib as Neoadjuvant Therapy for ccRCC | DecenTrialz