PD1 Inhibitors Combined With Clostridium Butyricum for Urothelial Carcinoma

Study on the Efficacy of Neoadjuvant or Adjuvant Therapy Based on PD1 Inhibitors Combined With Clostridium Butyricum Supplementation for Urothelial Carcinoma

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06696742

Enrollment

Registered

2024-11-20

Start date

2024-02-01

Completion date

2029-02-01

Last updated

2024-11-20

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

Conditions

Bladder (Urothelial, Transitional Cell) Cancer

Brief summary

This study intends to explore whether the combination of Clostridium butyricum can improve the current situation of poor anti-PD1 treatment effect in patients with bladder cancer.

Detailed description

This study intends to explore whether the combination of Clostridium butyricum can improve the current situation of poor anti-PD1 treatment effect in patients with bladder cancer. This study is divided into two parts. One is the patients with neoadjuvant therapy. After 3 cycles of neoadjuvant therapy, to observe whether the patients with Clostridium butyricum live tablets have better neoadjuvant therapy efficacy. The other was in patients with adjuvant therapy to see if adjuvant therapy combined with Clostridium butyricum could prolong the patient's prognosis.

Interventions

DRUGClostridium Butyricum Tablets

Gemcitabine and Cisplatin combined with Clostridium Butyricum Tablets

DRUGCisplatin

Gemcitabine and Cisplatin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

For Neoadjuvant therapy: * T2-T4aN0M0 bladder patients For Adjuvant therapy: * Postoperative pathological stage T3-T4 and/or lymph node metastasis were positive.

Exclusion criteria

* The researchers evaluated the patients who could not tolerate radical surgery; * Previously received systemic chemotherapy or immunotherapy; * There are active autoimmune diseases requiring systemic treatment or other diseases requiring long-term use of a large number of hormones and other immunosuppressants; * Have had major surgery or major trauma within 28 days before joining the group; * Vaccinated with live vaccine within 28 days before joining the group.

Design outcomes

Primary

Measure	Time frame	Description
PFS	3 years after surgery	Progression-Free Survival

Secondary

Measure	Time frame	Description
OS	3 years after surgery	Overall Survival

Countries

China

Contacts

Primary ContactXiao Yang

yangxiao2915@163.com+8613951813528

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026