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Multicenter clinical trial on the effectiveness of intravesical hematoporphyrin infusion photodynamic therapy combined with pirarubicin hydrochloride infusion chemotherapy in preventing postoperative recurrence of moderate to high-risk non-muscular invasive bladder cancer

Multicenter clinical trial on the effectiveness of intravesical hematoporphyrin infusion photodynamic therapy combined with pirarubicin hydrochloride infusion chemotherapy in preventing postoperative recurrence of moderate to high-risk non-muscular invasive bladder cancer

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046736
Enrollment
Unknown
Registered
2021-05-27
Start date
2021-07-01
Completion date
Unknown
Last updated
2022-01-10

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

Conditions

Bladder Cancer

Interventions

experimental group:intravesical hematoporphyrin infusion photodynamic therapy combined with pirarubicin hydrochloride infusion chemotherapy

Sponsors

Shenzhen Hospital, Cancer Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. The patient aged 18-80 years, and confirmed by histology as middle-high-risk non-muscular invasive bladder cancer. 2. ECOG score: 0-1 points; 3. Expected survival period >= 2 years; 4. Complete screening related examinations (blood routine, coagulation function, liver and kidney function, infectious disease screening, 12-lead electrocardiogram, urinary system B-ultrasound, pelvic enhanced CT or MR, histopathological examination), and no surgical contraindications; 5. Volunteer to participate in this trial and sign an informed consent form;

Exclusion criteria

Exclusion criteria: 1. Those who are known to be allergic to test drugs or related drugs; 2. Have a history of bladder contracture or the functional bladder volume is less than 100mL; 3. Patients with severe urethral stricture that cannot be inserted into a cystoscope; 4. Other tumors of the genitourinary system or other organs are found during the inspection; 5. Those who suffer from severe coagulation function, liver and kidney function, hematopoietic dysfunction, etc. who cannot tolerate surgical treatment 6. Those who suffer from immunocompromised, acquired, or congenital immunodeficiency diseases; 7. Suffering from various mental disorders, severe cardiovascular and cerebrovascular diseases, cardiopulmonary dysfunction, etc. who cannot tolerate surgery; 8. There are active infections: acute pneumonia, active tuberculosis, severe urinary tract infection; 9. Women during pregnancy and lactation; 10. Participated in other clinical trials in the past 30 days; 11. Patients judged by the investigator as unsuitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
Relapse-Free Survival, RFS;

Secondary

MeasureTime frame
Progression-Free Survival, PFS;

Countries

China

Contacts

Public ContactTian Jun

Shenzhen Hospital, Cancer Hospital, Chinese Academy of Medical Sciences

tianjun197010@hotmail.com+86 13911890203

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026