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Study on the drug resistance mechanism of RC48 combined with PDL1 (toripalimab) in the treatment of HER2-high expression bladder cancer

Study on the drug resistance mechanism of RC48 combined with PDL1 (toripalimab) in the treatment of HER2-high expression bladder cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600123818
Enrollment
Unknown
Registered
2026-04-30
Start date
2026-04-30
Completion date
Unknown
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder cancer

Interventions

Resistant/non-susceptible group:None
Susceptible group:None

Sponsors

Fuzhou University Affiliated Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Aged between 50-70 years old, no gender limit; (2) Locally advanced or metastatic urothelial carcinoma confirmed by histopathology or cytology; (3) Not suitable for receiving cisplatin-based chemotherapy; (4) Receive first-line treatment with RC48 combined with toripalimab; (5) The pre-treatment baseline tissue (FFPE) sample is complete and can be used for RNAseq sequencing analysis; (6) Complete clinicopathological data, including RECIST 1.1 efficacy evaluation results, progression-free survival (PFS), overall survival (OS), HER2 IHC status (IHC 2+/3+) and PD-L1 CPS score.

Exclusion criteria

Exclusion criteria: (1) Age below 50 years or above 70 years old; (2) Pathologically diagnosed non-urothelial cancer, or early-stage urothelial cancer, can be cured radically through surgery and does not require first-line treatment with RC48 combined with toripalimab; (3) Suitable for cisplatin-based chemotherapy regimen; (4) Not receiving first-line treatment with RC48 combined with toripalimab; (5) The baseline tissue (FFPE) sample before treatment is missing or incomplete, and RNAseq sequencing analysis cannot be performed; (6) Clinicopathological data are missing, and RECIST 1.1 efficacy evaluation, PFS/OS statistics, HER2 IHC status or PD-L1 CPS score determination cannot be completed.

Design outcomes

Primary

MeasureTime frame
Immune cell infiltration analysis;Differentially expressed gene related indicators;Biomarker Identification;Survival related indicators;Functional pathway enrichment analysis;

Countries

China

Contacts

Public ContactLiu Zhihua

Fuzhou University Affiliated Provincial Hospital

aukua@126.com+86 150 0508 6438

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026