Muscle Invasive Bladder CancerPhase 2NCT04101812
Pegylated Liposomal Doxorubicin, PD-1 in Treating Muscle Invasive Bladder Cancer
A Phase 2 study testing pegylated liposomal doxorubicin (PLD) and PD-1 in people with Muscle Invasive Bladder Cancer, run by Tianjin Medical University Second Hospital at 1 site in China.
Trial summary
Despite primary surgical management of muscle invasive bladder cancer (MIBC) with radical cystectomy and pelvic lymphnode dissection, up to 50% of patients will eventually develop tumours at distant sites, owing to pre-existing disseminated occult micrometastases. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Muscle Invasive Bladder Cancer
- What is being tested?
- pegylated liposomal doxorubicin (PLD) and PD-1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 17 Sep 2019to 31 May 2021
- 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
- Clinically confirmed muscle-invasive bladder cancer.
- Histologically confirmed by HE staining or IHC staining.
- Life expectancy of greater than or equal to 3 months.
- KPS performance >60, ECOG performance status ≤2.
- Adequate liver function with a bilirubin up to 1.5 x ULN. Transaminases up to 2.5 x ULN; for liver metastasis, transaminases up to 5 x ULN.
- Adequate bone marrow function, as defined by neutrophils count of ≥1.5×109/L, platelet count≥80×109/L, hemoglobin≥9.0g/dL.
Show all 10Show fewer
- Adequate renal function (serum creatinine ≤1.25 times the ULN, and the release rate of which ≥ 60ml/min).
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- Negative serum pregnancy test for female subjects with reproductive potential =< 7 days prior to registration, for women of childbearing potential only. All female patients of childbearing age and all male patients with partners of childbearing age should use a reliable method of contraception, such as the barrier method, throughout the study and for 8 weeks after last treatment.
- Sign the informed consent before any trial related activities.
Who cannot join
- A prior malignancy, other than non-melanoma skin cancer, carcinoma in situ, localized prostate cancer or ductal carcinoma in situ treated by surgery unless they have completed therapy at least 5 years prior to start of study and have no evidence of recurrent or residual disease
- Chemotherapy, biological therapy or other anti-cancer drugs ≤ 28 days prior to pre-registration
- Factors that would affect taking medicine orally, such as dysphagia, chronic diarrhea and intestinal obstruction
- History of arterial/venous thrombus ≤ 6 months prior to registration, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism
- History or tendency of gastrointestinal hemorrhage caused by severe gastroesophageal varices or other reasons.
- Dysfunction of blood coagulation: prothrombin time (PT)>16s, activated partial thromboplastin time (APTT) >43s, thrombin time (TT) >21s, INR >2, fibrinogen < 2g/L, bleeding tendency or under thrombolytic or anticoagulant therapy
Show all 12Show fewer
- Uncontrolled intercurrent illness including, but not limited to:
- ongoing or active infection; poor controlled diabetes (FBG > 10 mmol/L); urine protein ≥++, and UAE > 1.0g/24h; myocardial ischemia; congestive heart failure; cardiac arrhythmia or cardiac insufficiency; LVEF < 50%
- Unhealed wounds, ulcers or fractures
- Abuse of psychotropic substances or mentally disturbed
- History of HIV, organ transplantation or any other acquired, congenital immunodeficiency diseases
- Patients evaluated not suitable for the study in the opinion of investigators
Trial locations and contacts
1 site in 1 country.
Lili Wang contact
China1 site, 1 recruiting
- Recruiting
Tianjin Medical Unversity Second Hospital
Tianjin, Tianjin Municipality
Haitao Wang
Lili Wang
About this study
Official title: A Non-randomized, Prospective Clinical Study of Pegylated Liposomal Doxorubicin and PD-1 in the Second-line Treatment of Relapse or Metastatic Muscle Invasive Bladder Cancer
Despite primary surgical management of muscle invasive bladder cancer (MIBC) with radical cystectomy and pelvic lymphnode dissection, up to 50% of patients will eventually develop tumours at distant sites, owing to pre-existing disseminated occult micrometastases. The first line treatment for relapse or metastatic MIBC is gemcitabine and cisplatin. After the failure of first line treatment, second line chemotherapy drugs can be chosen from doxorubicin, docetaxel, pemetrexed, etc. This non-randomized, prospective study aims to explore the efficacy and safety of PEGylated liposomal doxorubicin and PD-1 in second line treatment of MIBC.
- Conditions
- Muscle Invasive Bladder Cancer
- Being tested
- pegylated liposomal doxorubicin (PLD), PD-1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pegylated liposomal doxorubicin (PLD)Drug
Also called Doxorubicin Hydrochloride Liposome Injection
PLD is an anthracycline topoisomerase II inhibitor that is encapsulated in liposomes for intravenous use.
PD-1Drug
PD-1 monoclonal antibody is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands and PD-L1.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Experimental group Pegylated liposomal doxorubicin 40mg/m2 iv every 3 weeks, for 3 cycles; PD-1 every 3 weeks, for 3 cycles. Receives: Drug: pegylated liposomal doxorubicin (PLD); Drug: PD-1 |
| Control group | Active comparator | PD-1 every 3 weeks, for 6 cycles. Receives: Drug: PD-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease control rate
Disease control rate defined as confirmed complete response or partial response or stable disease under RECIST 1.0 criteria.
Measured: at least 10 months
Objective response rate
Objective response rate defined as confirmed complete response or partial response under RECIST 1.0 criteria.
Measured: at least 10 months
Secondary outcomes (2)
Progression free survival
Progression-free survival estimated using Kaplan-Meier methods is defined as the time from registration to the earlier of death or disease progression.
Measured: at least 10 months
Overall survival
Overall survival estimated using Kaplan-Meier methods is defined as the time from treatment initiation to death by any cause
Measured: at least 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start17 Sep 2019
- Primary completion31 May 2020 (estimated)
- Study completion31 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Invasive Bladder CancerStudies of the same condition, open and under way.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Second Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- CSPC Pharmaceutical Group Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04101812
- Sponsor's protocol ID
- DMSMIBC-01
- Status last verified
- Sep 2019
- First submitted
- 17 Sep 2019
- Last updated
- 26 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-randomized, Prospective Clinical Study of Pegylated Liposomal Doxorubicin and PD-1 in the Second-line Treatment of Relapse or Metastatic Muscle Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT04101812
- Acronym / sponsor ID
- DMSMIBC-01
- Conditions
- Muscle Invasive Bladder Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tianjin Medical University Second HospitalUniversity, hospital or other
- Collaborators
- CSPC Pharmaceutical Group Limited
- Study start
- 17 Sep 2019 (actual)
- Primary completion
- 31 May 2020 (estimated)
- Study completion
- 31 May 2021 (estimated)
- First posted
- 24 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.
Despite primary surgical management of muscle invasive bladder cancer (MIBC) with radical cystectomy and pelvic lymphnode dissection, up to 50% of patients will eventually develop tumours at distant sites, owing to pre-existing disseminated occult micrometastases. The first line treatment for relapse or metastatic MIBC is gemcitabine and cisplatin. After the failure of first line treatment, second line chemotherapy drugs can be chosen from doxorubicin, docetaxel, pemetrexed, etc. This non-randomized, prospective study aims to explore the efficacy and safety of PEGylated liposomal doxorubicin and PD-1 in second line treatment of MIBC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: pegylated liposomal doxorubicin (PLD), Drug: PD-1Experimental group Pegylated liposomal doxorubicin 40mg/m2 iv every 3 weeks, for 3 cycles; PD-1 every 3 weeks, for 3 cycles. |
| Control group | Active comparator | Drug: PD-1PD-1 every 3 weeks, for 6 cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Clinically confirmed muscle-invasive bladder cancer.
- Histologically confirmed by HE staining or IHC staining.
- Life expectancy of greater than or equal to 3 months.
- KPS performance >60, ECOG performance status ≤2.
- Adequate liver function with a bilirubin up to 1.5 x ULN. Transaminases up to 2.5 x ULN; for liver metastasis, transaminases up to 5 x ULN.
Key exclusion criteria (12 listed)
- A prior malignancy, other than non-melanoma skin cancer, carcinoma in situ, localized prostate cancer or ductal carcinoma in situ treated by surgery unless they have completed therapy at least 5 years prior to start of study and have no evidence of recurrent or residual disease
- Chemotherapy, biological therapy or other anti-cancer drugs ≤ 28 days prior to pre-registration
- Factors that would affect taking medicine orally, such as dysphagia, chronic diarrhea and intestinal obstruction
- History of arterial/venous thrombus ≤ 6 months prior to registration, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism
- History or tendency of gastrointestinal hemorrhage caused by severe gastroesophageal varices or other reasons.
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 |
|---|---|---|
| pegylated liposomal doxorubicin (PLD)Also: Doxorubicin Hydrochloride Liposome InjectionPLD is an anthracycline topoisomerase II inhibitor that is encapsulated in liposomes for intravenous use. | Drug | Experimental group |
| PD-1PD-1 monoclonal antibody is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands and PD-L1. | Drug | Control group, Experimental group |
Primary outcome
Disease control rate
Time frame: at least 10 months
Disease control rate defined as confirmed complete response or partial response or stable disease under RECIST 1.0 criteria.
Objective response rate
Time frame: at least 10 months
Objective response rate defined as confirmed complete response or partial response under RECIST 1.0 criteria.
2 secondary outcomes
Progression free survival
Time frame: at least 10 months
Overall survival
Time frame: at least 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Muscle Invasive Bladder Cancer
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine PF-08052667 in People With Bladder Cancer
Non-muscle Invasive Bladder Cancer
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingPhase 1
FORAGER-1: A Study of Vepugratinib (LY3866288; LOXO-435) in Participants With Cancer With a Change in a Gene Called FGFR3
Urinary Bladder Neoplasms, Neoplasm Metastasis
RecruitingObservational study
Mood Alterations in the Patients With Non-Muscle Invasive Bladder Cancer Treated With BCG
Non-Muscle Invasive Bladder Cancer
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.
Lili Wang contact
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 pegylated liposomal doxorubicin (PLD) and PD-1 in people with Muscle Invasive Bladder Cancer, run by Tianjin Medical University Second Hospital 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 10 inclusion and 12 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 26 Sep 2019. 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 Haitao Wang ((022)28331788, peterrock2000@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease control rate (time frame: at least 10 months). The study lists 2 primary outcomes in all. 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 26 Sep 2019.