# A Study of SHR-1501 Combination With BCG Versus Placebo Combined With BCG in Subjects With Papillary-Only NMIBC

Source: https://onco.cc/trials/nct07726992/  
OnCo record `nct07726992` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial testing SHR-1501 in bladder & urothelial cancer, now recruiting.

## Summary

A Study of SHR-1501 Combination With BCG Versus Placebo Combined With BCG in Subjects With Papillary-Only NMIBC is a phase 3 interventional study registered as NCT07726992, led by Suzhou Suncadia Biopharmaceuticals, and recruiting on the registry. Official title: A Multicenter, Randomised, Double-blind Phase III Study of Intravesical SHR-1501 Combined With Bacillus Calmette Guerin (BCG) Versus Placebo Combined With BCG In Patients With High-risk BCG-naive Papillary-Only Non-muscle-invasive Bladder Cancer (NMIBC). Planned enrolment is 750 participants (estimated). The study started in 2026-08-25 and primary completion is expected in 2029-12. No results have been posted on ClinicalTrials.gov.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-11
- Also known as: NiBladder 2
- Tags: ctgov-ingest
- Registry id: NCT07726992
- Phase: 3
- Setting: A Multicenter, Randomized, Double-blind Phase III Study of Intravesical SHR-1501 Combined With Bacillus Calmette Guerin (BCG) Versus Placebo Combined With BCG In Patients With High-risk BCG-naive Papillary-Only Non-muscle-invasive Bladder Cancer (NMIBC)
- Sponsor: Suzhou Suncadia Biopharmaceuticals
- Enrolled: 750

## Sources

- ClinicalTrials.gov NCT07726992: https://clinicaltrials.gov/study/NCT07726992

## Connected records

- cancers: [Bladder & urothelial cancer](https://onco.cc/cancers/urothelial/), [Non-muscle-invasive bladder cancer](https://onco.cc/cancers/non-muscle-invasive-bladder-cancer/)
- drugs: [SHR-1501](https://onco.cc/drugs/shr-1501/)
- companies: [Jiangsu Hengrui Pharmaceuticals](https://onco.cc/companies/hengrui/)

---
JSON: https://onco.cc/api/v1/entities/nct07726992.json