PD1 Inhibitors Combined With Clostridium Butyricum for Urothelial Carcinoma

Nanjing Medical University

Status and phase: Enrolling; Phase 2

Conditions: Bladder (Urothelial, Transitional Cell) Cancer

Treatments: Drug: Cisplatin; Drug: Clostridium Butyricum Tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT06696742

2024-SR-371

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

GC+anti-PD1+Clostridium butyricum

Experimental group

Description:

For Neoadjuvant therapy * GC: gemcitabine (1.0 g/m2 on days 1 and 8) and cisplatin (70 mg/m2 evenly distributed over days 2 to 4) every 21 days for 3 cycles. * PD1: Tislelizumab 200mg every 21 days for 3 cycles. ③Clostridium butyricum: Clostridium Butyricum Tablets, 20mg, twice a day. For Adjuvant Therapy: ①PD1: Tislelizumab 200mg every 21 days for 1-2 year. ②Clostridium butyricum: Clostridium Butyricum Tablets, 20mg, twice a day.

Treatment:

Drug: Clostridium Butyricum Tablets

GC+anti-PD1

Active Comparator group

Description:

For Neoadjuvant therapy ①GC: gemcitabine (1.0 g/m2 on days 1 and 8) and cisplatin (70 mg/m2 evenly distributed over days 2 to 4) every 21 days for 3 cycles. ②PD1: Tislelizumab 200mg every 21 days for 3 cycles. For Adjuvant Therapy: ①PD1: Tislelizumab 200mg every 21 days for 1-2 year.

Treatment:

Drug: Cisplatin