Bladder (Urothelial, Transitional Cell) CancerPhase 2NCT06696742
PD1 Inhibitors Combined With Clostridium Butyricum for Urothelial Carcinoma
A Phase 2 study testing Clostridium Butyricum Tablets and Cisplatin in people with Bladder (Urothelial, Transitional Cell) Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder (Urothelial, Transitional Cell) Cancer
- What is being tested?
- Clostridium Butyricum Tablets and Cisplatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2024to 1 Feb 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For Neoadjuvant therapy:
- T2-T4aN0M0 bladder patients
- For Adjuvant therapy:
- Postoperative pathological stage T3-T4 and/or lymph node metastasis were positive.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Xiao Yang, +8613951813528, yangxiao2915@163.com
About this study
Official title: Study on the Efficacy of Neoadjuvant or Adjuvant Therapy Based on PD1 Inhibitors Combined With Clostridium Butyricum Supplementation for Urothelial Carcinoma
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.
Read the 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.
- Being tested
- Clostridium Butyricum Tablets, Cisplatin
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clostridium Butyricum TabletsDrug
Also called Cisplatin, Gemcitabine
Gemcitabine and Cisplatin combined with Clostridium Butyricum Tablets
CisplatinDrug
Also called Gemcitabine
Gemcitabine and Cisplatin
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression-Free Survival
Measured: 3 years after surgery
Secondary outcomes (1)
OS
Overall Survival
Measured: 3 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start1 Feb 2024
- Primary completion1 Feb 2029 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder (Urothelial, Transitional Cell) CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qiang Lu, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06696742
- Sponsor's protocol ID
- 2024-SR-371
- Status last verified
- Nov 2024
- First submitted
- 30 Oct 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Efficacy of Neoadjuvant or Adjuvant Therapy Based on PD1 Inhibitors Combined With Clostridium Butyricum Supplementation for Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT06696742
- Acronym / sponsor ID
- 2024-SR-371
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 20 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GC+anti-PD1+Clostridium butyricum | Experimental | Drug: Clostridium Butyricum TabletsFor 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. |
| GC+anti-PD1 | Active comparator | Drug: CisplatinFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- T2-T4aN0M0 bladder patients
- Postoperative pathological stage T3-T4 and/or lymph node metastasis were positive.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clostridium Butyricum TabletsAlso: Cisplatin, GemcitabineGemcitabine and Cisplatin combined with Clostridium Butyricum Tablets | Drug | GC+anti-PD1+Clostridium butyricum |
| CisplatinAlso: GemcitabineGemcitabine and Cisplatin | Drug | GC+anti-PD1 |
Primary outcome
PFS
Time frame: 3 years after surgery
Progression-Free Survival
1 secondary outcome
OS
Time frame: 3 years after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Qiang Lu principal investigator
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Clostridium Butyricum Tablets and Cisplatin in people with Bladder (Urothelial, Transitional Cell) Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiao Yang (+8613951813528, yangxiao2915@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 3 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.