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Not yet recruiting NCT07726992

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

Phase III Interventional Papillary-Only Non-muscle-invasive Bladder Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SHR-1501+BCG, Placebo +BCG.
Who it may be relevant to
Registry conditions: Papillary-Only Non-muscle-invasive Bladder Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

Overview

This is a multicenter, randomized, Double-blind phase III study to determine the efficacy and safety 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)

Interventions

  • Drug SHR-1501+BCG
    SHR-1501+BCG
  • Drug Placebo +BCG
    Placebo +BCG

Primary outcome measures

  • Disease-Free Survival (DFS) assessed by BICR: Disease-free survival is defined as the time from randomization to date of DFS event assessed by BICR. [Time frame: Up to approximately 5 years]
Secondary outcome measures (4)
  • Disease-Free Survival (DFS) assessed by investigator: Disease-free survival is defined as the time from randomization to date of DFS event assessed by investigator. [Time frame: Up to approximately 5 years]
  • Overall Survival (OS): Overall Survival defined as the time from randomization to the date of death from any cause. [Time frame: Up to approximately 5 years.]
  • Number of adverse events (AEs) as assessed by CTCAE v6.0. [Time frame: Up to approximately 5 years.]
  • Number of serious adverse events (SAEs) as assessed by CTCAE v6.0. [Time frame: Up to approximately 5 years.]

Eligibility criteria

Inclusion criteria

  • Aged at least 18 years, gender is not limited;
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2;
  • Histologic confirmation of high-riskpapillary-only non-muscle invasive bladder cancer (high-grade Ta and/or any T1, no carcinoma in situ);
  • No previous BCG therapy;
  • Cystoscopy within 6 weeks before the randomization shows that the lesion has been completely removed; for T1 stage lesions, pathological results must show the presence of bladder muscle tissue;
  • Sufficient hematology and organ function;

Exclusion criteria

  • Previous histopathological diagnosis was muscle-invasive, locally advanced or metastatic urothelial carcinoma (T2 or T3 or T4 or N+ or M+).
  • Received surgery such as TURBT or radiotherapy for bladder lesions within 2 weeks before the randomization; Major surgery was performed within 28 days before randomization;
  • Those who have previously received immunostimulant therapy or immune checkpoint inhibitors;
  • Those who have previously received intravesical instillation of cytotoxic chemotherapy and have not experienced disease recurrence or progression before enrolment as assessed by investigator;
  • Those who plan to undergo radical (partial) cystectomy during the study;
  • Upper urinary tract tumor detected by CTU or MRU during screening period, urethral prostate tumor detected by cystoscopy, or other concomitant malignant tumors within 5 years before the first administration;
  • Previous medical history or examination suggests active tuberculosis within 1 year prior to the randomization;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 2 centers
  • The First Medical Center of the Chinese People's Liberation Army General Hospital — Beijing
  • Sun Yat-sen University Cancer Center — Guangzhou

Identifiers

NCT: NCT07726992 · SHR-1501-302

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗