Upper Tract Urinary CarcinomaPhase 2NCT04099589
Neoadjuvant Treatment of Upper Urinary and Muscular Invasive Bladder Urothelial Carcinoma
A Phase 2 study testing Toripalimab in people with Upper Tract Urinary Carcinoma and Muscle-invasive Bladder Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
Few previous studies focused on the neoadjuvant treatments of upper urinary or bladder cancer, especially chemotherapy combined with immunotherapy, however, available data of retrospective studies showed this neoadjuvant treatment model might benefit patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Upper Tract Urinary Carcinoma, Muscle-invasive Bladder Cancer
- What is being tested?
- Toripalimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2019to 1 Oct 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- bladder cancer of T2-4aN0M0
- upper tract urinary carcinoma of T1-3N0M0 and high grade
- ECOG 0-1
- good organ function
- no previous chemotherapy or immunotherapy
- Informed consent form signed
Who cannot join
- unable to receive chemotherapy or surgery due to physical abnormalities
- previous cancer history
- active tuberculosis
- HIV
- autoimmune disease
- anticipating other clinical studies
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Jianzhong Shou, MD, 13601332989, shoujzh@126.com
About this study
Official title: Multicenter Phase II Study of Gemcitabine/Cisplatin (GC) Chemotherapy Combined With PD-1 Inhibitor (Toripalimab) in the Neoadjuvant Treatment of Upper Urinary and Muscular Invasive Bladder Urothelial Carcinoma
Few previous studies focused on the neoadjuvant treatments of upper urinary or bladder cancer, especially chemotherapy combined with immunotherapy, however, available data of retrospective studies showed this neoadjuvant treatment model might benefit patients. So This prospective Phase II clinical trial was designed to explore the efficacy of chemotherapy combined with PD-1 inhibitor as neoadjuvant therapy in upper urinary and muscle-invasive bladder urothelial carcinoma, then to improve the rate of complete pathological remission, survival and provide medical evidence.
- Being tested
- Toripalimab
- Keywords
- upper tract urinary carcinoma, muscle-invasive bladder cancer, neoadjuvant, chemotherapy, immunotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToripalimabDrug
Gemcitabine/Cisplatin plus Toripalimab
| Study group | Role | What they receive |
|---|---|---|
| MIBC Group | Experimental | Muscle-invasive bladder cancer of T2-4aN0M0 confirmed by pathology after maximal transurethral resection of bladder tumors. Enrollment of 30 patients. Receives: Drug: Toripalimab |
| UTUC Group | Experimental | Upper tract urothelial carcinoma of T1-3N0M0 and high grade confirmed by flexible ureteroscope biopsy. Enrollment of 34 patients. Receives: Drug: Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathological complete response rate
the percentage of pT0N0 patients after operations
Measured: through study completion of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start1 Oct 2019
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Tract Urinary CarcinomaStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianzhong Shou, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Jianzhong Shou, Principal investigator, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04099589
- Sponsor's protocol ID
- NCC2121
- Status last verified
- Mar 2022
- First submitted
- 19 Sep 2019
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Phase II Study of Gemcitabine/Cisplatin (GC) Chemotherapy Combined With PD-1 Inhibitor (Toripalimab) in the Neoadjuvant Treatment of Upper Urinary and Muscular Invasive Bladder Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT04099589
- Acronym / sponsor ID
- NCC2121
- Keywords
- upper tract urinary carcinoma, muscle-invasive bladder cancer, neoadjuvant, chemotherapy, immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Peking University First Hospital, China-Japan Friendship Hospital
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 23 Sep 2019 (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.
Few previous studies focused on the neoadjuvant treatments of upper urinary or bladder cancer, especially chemotherapy combined with immunotherapy, however, available data of retrospective studies showed this neoadjuvant treatment model might benefit patients. So This prospective Phase II clinical trial was designed to explore the efficacy of chemotherapy combined with PD-1 inhibitor as neoadjuvant therapy in upper urinary and muscle-invasive bladder urothelial carcinoma, then to improve the rate of complete pathological remission, survival and provide medical evidence.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIBC Group | Experimental | Drug: ToripalimabMuscle-invasive bladder cancer of T2-4aN0M0 confirmed by pathology after maximal transurethral resection of bladder tumors. Enrollment of 30 patients. |
| UTUC Group | Experimental | Drug: ToripalimabUpper tract urothelial carcinoma of T1-3N0M0 and high grade confirmed by flexible ureteroscope biopsy. Enrollment of 34 patients. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- bladder cancer of T2-4aN0M0
- upper tract urinary carcinoma of T1-3N0M0 and high grade
- ECOG 0-1
- good organ function
- no previous chemotherapy or immunotherapy
Key exclusion criteria (6 listed)
- unable to receive chemotherapy or surgery due to physical abnormalities
- previous cancer history
- active tuberculosis
- HIV
- autoimmune disease
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 |
|---|---|---|
| ToripalimabGemcitabine/Cisplatin plus Toripalimab | Drug | MIBC Group, UTUC Group |
Primary outcome
pathological complete response rate
Time frame: through study completion of 3 years
the percentage of pT0N0 patients after operations
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
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Study BT5528-100 in Patients With Advanced Solid Tumors Associated With EphA2 Expression
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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. This study is not recruiting at the moment.
Jianzhong Shou principal investigator
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
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 Toripalimab in people with Upper Tract Urinary Carcinoma and Muscle-invasive Bladder Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 29 Mar 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianzhong Shou (86-18813019104, chuanzhenc@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathological complete response rate (time frame: through study completion of 3 years). 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 29 Mar 2022.