SHR-1501 Combined With SHR-2005 for High-Risk Non-Muscle Invasive Bladder Cancer Which is Not Completely Resectable by TURBt

ConditionNMIBC
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFudan University

About this trial

This is a single-center, single-arm, phase Ib/II study, aimed at assessing the safety and efficacy of SHR-1501 in combination with SHR-2005 as treatment for patients with high-risk non-muscle invasive bladder cancer (HR NMIBC) which is not completely resectable by transurethral resection of bladder tumor (TURBt).

Eligibility criteria

Qualifiers

Age ≥18 years old, both genders

Previous pathological biopsy was diagnosed as high-risk NMIBC

Tumors cannot be completely resected by TURBT(at least 2 senior urologists assessed that the lesion area is too extensive to be completely resected)

Ineligible or unwilling to undergo radical cystectomy

Disqualifiers

Previous pathological biopsy was diagnosed with muscle-invasive bladder cancer at T2 or higher stages

Received any other intravesical chemotherapy treatment within 2 weeks or received any other clinical drugs within 4 weeks

History of allergy to any of the study drugs or study drug components

Upper urinary tract tumor detected by CTU or MRU during screening period or other concomitant malignant tumors within 5 years before the first administration

Trial design

Treatments tested in this trial

  • SHR-1501+SHR-2005

Treatment groups

58 Participants
are divided into 1 treatment group

Sponsors and collaborators