PD1 Inhibitors Combined With Clostridium Butyricum for Urothelial Carcinoma

NCT06696742 | Recruiting Phase 2

• 1 other identifier: 2024-SR-371
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder (Urothelial, Transitional Cell) Cancer

Outcome Measures

Primary Outcomes (1)

• PFS

  Progression-Free Survival

  3 years after surgery

Secondary Outcomes (1)

• OS

  3 years after surgery

Study Arms (2)

GC+anti-PD1+Clostridium butyricum

EXPERIMENTAL

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.

Drug: Clostridium Butyricum Tablets

GC+anti-PD1

ACTIVE COMPARATOR

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.

Drug: Cisplatin

Interventions

Clostridium Butyricum Tablets DRUG

Gemcitabine and Cisplatin combined with Clostridium Butyricum Tablets

Also known as: Cisplatin, Gemcitabine

GC+anti-PD1+Clostridium butyricum

Cisplatin DRUG

Gemcitabine and Cisplatin

Also known as: Gemcitabine

GC+anti-PD1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Cisplatin; Gemcitabine

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Qiang Lu

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiao Yang

CONTACT

+8613951813528; yangxiao2915@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 20, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029
• Last Updated: November 20, 2024

Record last verified: 2024-11

Locations

CN (1)