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OncoMatch/Clinical Trials/NCT07386158

Pucotenlimab Combination With Vorolanib as Neoadjuvant Therapy for ccRCC

Is NCT07386158 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Pucotenlimab combination with Vorolanib for vorolanib.

Phase 2RecruitingSun Yat-sen UniversityNCT07386158Data as of Jun 2026Location: China

Treatment: Pucotenlimab combination with VorolanibThrough 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)

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Extracted eligibility criteria

Treatments studied

Targeted therapy

Pucotenlimab combination with Vorolanib

Cancer type

Renal Cell Carcinoma

Disease stage

Required: Stage T1BN0M0, T2N0M0

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 85

Prior therapy

Cannot have received: Chinese herbal medicine or immunomodulatory drugs with anti-tumor indications

Received Chinese herbal medicine or immunomodulatory drugs with anti-tumor indications within 14 days prior to the first use of the investigational drug

Cannot have received: systematic treatment (including thymosin, interferon, interleukin, except for local use to control pleural effusion)

Exception: except for local use to control pleural effusion

Perform systematic treatment (including thymosin, interferon, interleukin, except for local use to control pleural effusion)

Lab requirements

Blood counts

ANC ≥ 1.5 × 10^9/L (1500/mm3); Platelet count (PLT) ≥ 100 × 10^9/L (100000/mm3); Hemoglobin (HB) ≥ 90 g/L

Kidney function

Preoperative assessment of healthy kidney GFR<60 ml/min through renal dynamic imaging

Liver function

Serum total bilirubin (TBIL) ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN; For subjects with liver metastasis, AST and ALT ≤ 5 × ULN; Serum albumin (ALB) ≥ 28g/L

Good organ function, laboratory test results during the screening period meet the following criteria: Hematology... Liver... Coagulation function: INR and APTT ≤ 1.5 × ULN

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT07386158 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior Chinese herbal medicine or immunomodulatory drugs with anti-tumor indications, systematic treatment (including thymosin, interferon, interleukin, except for local use to control pleural effusion) disqualifies patients from enrollment.

What disease stage is eligible?

Stage T1BN0M0 or T2N0M0 is required.

Is there an age limit?

Yes. Patients must be 85 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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