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NCT06341400
RC48 Combined with Toripalimab As Neoadjuvant Therapy for Cisplatin Ineligible MIBC Patients
Phase 1, PHASE2 trial testing DisitamabVedotinForIicction Toripalimab in Bladder Cancer in 55 participants. Currently enrolling.
1 May 2026
Quick facts
| Lead sponsor | Zhujiang Hospital |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 55 |
| Start date | 19 June 2024 |
| Primary completion | 1 May 2026 |
| Estimated completion | 1 May 2027 |
| Sites | 1 location across China |
Drugs / interventions tested
- DisitamabVedotinForIicction Toripalimab — full drug profile →
Conditions studied
- Bladder Cancer — all drugs for Bladder Cancer →
- Muscle-Invasive Bladder Carcinoma — all drugs for Muscle-Invasive Bladder Carcinoma →
Sponsor
Zhujiang Hospital
Who can join
18 and older, any sex, with Bladder Cancer or Muscle-Invasive Bladder Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A single-arm, prospective, exploratory clinical trial to explore the pathological complete response (pCR) rate of immune checkpoint inhibitors combined with antibody conjugate drugs as the perioperative treatment of platinum-intolerant bladder cancer patients. Fifty-five patients with clinically or pathologically confirmed muscle-invasive bladder urothelial carcinoma (MIBC) who were ineligible for cisplatin-based chemotherapy or refused cisplatin-based chemotherapy were enrolled. Each subject will receive RC48-ADC and toripalimab intravenously every 2 weeks for a total of 4 cycles before surgery, 8 cycles after surgery. The efficacy was evaluated and followed up after 4 cycles of neoadjuvant therapy, 3 months postoperative, and every 3-6 months thereafter. The primary endpoint of this study was pathological complete response rate (pCR). The secondary endpoints were to explore the safety, disease-free survival (DFS), overall survival (OS), objective response rate (ORR) and disease control rate (DCR) of RC48 combined with toripalimab neoadjuvant therapy followed by radical cystectomy.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
The Dynamic Field of Perioperative Treatment for Localized Muscle-Invasive Bladder Cancer: A Review of the Current Research Landscape.
García-Rayo C, Juste-Álvarez S, Gómez-Cañizo C, Hernández-Arroyo M, et al · · 2025 · cited 2× · PMID 40869479 · DOI 10.3390/jcm14165653 -
Current Trends in Clinical Trials of Prodrugs.
Boreski D, Schmid VF, Bosquesi PL, Dos Santos JL, et al · · 2025 · cited 2× · PMID 40006024 · DOI 10.3390/ph18020210 -
Neoadjuvant treatment patterns and biomarker selection in muscle-invasive bladder cancer.
He W, Xie J, Wang Z, Wang M, et al · · 2025 · cited 1× · PMID 40591027 · DOI 10.1007/s12672-025-02796-6
Verify or expand the search:
- PubMed search for NCT06341400
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Bladder Cancer
Currently open trials in the same condition.
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Other Zhujiang Hospital trials
Trials by the same sponsor.
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- NCT07469072 — Comparison of Anticoagulant Effects of Different Doses of Nafamostat in Continuous Renal Replacement Therapy (CRRT) in t · Phase 2 · recruiting
- NCT07455149 — An Observational Clinical Study on the Association of Intestinal Ruminococcus Gnavus and Its Derived Biogenic Amines Wit · not yet recruiting
- NCT07457099 — Impact of Postoperative Radiotherapy Versus PD-1 Inhibitor Maintenance on Survival in Resectable Locally Advanced Oral a · not yet recruiting
- NCT07454421 — Racecadotril for Organ Injury in Sepsis Patients · Phase 1, PHASE2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06341400 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Zhujiang Hospital
- Last refreshed: 4 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06341400.
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