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Intermittent PD-1/PD-L1 ICI + VEGFR-TKI

Phase 2

Renal Cell Carcinoma (RCC) | Small molecule | Oncology |China Pharma Holdings, Inc.|Last Updated: Sep 16, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07175480PET/CT-Directed Free of Therapy for Metastatic RCC Patients With IMDC Favorable or Intermediate RiskPHASE2 RECRUITING 30 — — Jan 24, 2025Aug 1, 2030Sep 16, 20251 China
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Study Endpoints
Primary Endpoints
Progression-free survival (PFS) rate
24 months from treatment initiation

Proportion of participants alive and without disease progression at 24 months will be assessed according to PERCIST 1.0 criteria.

Secondary Endpoints
Duration of response (DoR)
From treatment interruption until disease progression or death, assessed up to 24 months
Overall survival (OS)
From treatment initiation until death from any cause, assessed up to 5 years
Progression free survival (PFS)
From treatment initiation until disease progression or death from any cause, assessed up to 5 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment pauseEXPERIMENTALPatients achieving complete metabolic response (CMR) or partial metabolic response (PMR) on PET/CT within 24 months discontinue combination regimens with the possibility to restart initial treatment at progression.
Interventions
NameTypeDescription
Intermittent PD-1/PD-L1 ICI + VEGFR-TKIDRUGAny PD-1/PD-L1 inhibitor or VEGFR-TKI that is commercially marketed, regulatory-approved and reimbursed under public health plans.Dose as recommended by the manufacturer.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Pre-screening Inclusion Criteria: 1. Male or female subjects aged ≥ 18 years at time of signing informed consent 2. Locally advanced (not amenable to curative surgery or radiation therapy) or metastatic RCC (American Joint Committee on Cancer \[AJCC\] Stage IV) 3. Favorable or intermediate risk as ...

Countries:China
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