NCT05975307Active, not recruitingPhase 2
Treating Muscle-invasive Bladder Cancer With A Non-surgical Method Consisting of Anti-PD-1 Therapy and Chemoradiation
A Single-arm, Phase II Clinical Trial to Treat Muscle-invasive Bladder Cancer With Neoadjuvant Chemotherapy Plus Anti-PD-1 Therapy Followed by Radiotherapy Plus Concurrent Anti-PD-1 Therapy
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
The goal of this Phase 2 trial is to evaluate a non-surgical bladder-preserving treatment mode which consists of neoadjuvant chemotherapy plus anti-programmed cell death protein 1 (anti-PD-1) therapy followed by radiotherapy plus concurrent anti-PD-1 therapy. The main questions it aims to answer are: (i) whether the anti-PD-1 antibody, toripalimab, is effective in treating muscle-invasive bladder cancer (MIBC), when combined with chemoradiation; (ii) whether toripalimab is safe in combination with chemoradiation. Participants will receive 3 cycles of neoadjuvant treatment containing chemotherapy with gemcitabine and cisplatin/carboplatin, plus toripalimab. Then the ones without progressive disease will receive radical radiotherapy plus 2 cycles of concurrent toripalimab.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 64 (estimated)
- First submitted
- 27 Jul 2023
- Start date
- 1 Dec 2023
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Bladder cancer
- NCT number
- NCT05975307
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 64
- From 1 Dec 2023 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior history of pelvic radiotherapy or chemotherapy
- Treatment with glucocorticoid or immunosuppressive drugs within 1 month
Other illness
- Existence of small cell cancer component
- Uncontrolled tuberculosis, viral hepatitis or AIDS
- Autoimmune or mental diseases
- Severe cardiac, renal, hepatic or hematopoietic dysfunctions unsuitable for chemotherapy, radiotherapy or immune checkpoint inhibiting therapy
- Prior history of other malignancies within 5 years, except cured cervical carcinoma in situ and skin basal cell carcinoma
Other
- Simultaneous tumors of the urethra or upper urinary tract
- Poor adherence to regular follow-up (cystoscopy, CT, MRI, etc.)
- Pregnant or lactating women
- Other situations for which the investigators consider a patient inappropriate to participate
Who the study is looking for
- Pathologically diagnosed bladder malignant tumor via biopsy
- Urothelial carcinoma as the primary histological component
- Pretreatment clinical TNM stage as T2-4aN0-2M0 (UICC TNM staging classification, version 8)
- Age between 18 and 75 years old
- Karnofsky performance score ≥ 70
- Creatinine clearance rate ≥ 30 ml/min
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cancer Center, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.