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Pegylated Liposomal Doxorubicin, PD-1 in Treating Muscle Invasive Bladder Cancer

Primary Purpose

Muscle Invasive Bladder Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
pegylated liposomal doxorubicin (PLD)
PD-1
Sponsored by
Tianjin Medical University Second Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Invasive Bladder Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • Tianjin Medical Unversity Second HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control group

Arm Description

Experimental group Pegylated liposomal doxorubicin 40mg/m2 iv every 3 weeks, for 3 cycles; PD-1 every 3 weeks, for 3 cycles.

PD-1 every 3 weeks, for 6 cycles.

Outcomes

Primary Outcome Measures

Disease control rate
Disease control rate defined as confirmed complete response or partial response or stable disease under RECIST 1.0 criteria.
Objective response rate
Objective response rate defined as confirmed complete response or partial response under RECIST 1.0 criteria.

Secondary Outcome Measures

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.
Overall survival
Overall survival estimated using Kaplan-Meier methods is defined as the time from treatment initiation to death by any cause

Full Information

First Posted
September 17, 2019
Last Updated
September 25, 2019
Sponsor
Tianjin Medical University Second Hospital
Collaborators
CSPC Pharmaceutical Group Limited
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1. Study Identification

Unique Protocol Identification Number
NCT04101812
Brief Title
Pegylated Liposomal Doxorubicin, PD-1 in Treating Muscle Invasive Bladder Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 17, 2019 (Actual)
Primary Completion Date
May 31, 2020 (Anticipated)
Study Completion Date
May 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Second Hospital
Collaborators
CSPC Pharmaceutical Group Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Invasive Bladder Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Experimental group Pegylated liposomal doxorubicin 40mg/m2 iv every 3 weeks, for 3 cycles; PD-1 every 3 weeks, for 3 cycles.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
PD-1 every 3 weeks, for 6 cycles.
Intervention Type
Drug
Intervention Name(s)
pegylated liposomal doxorubicin (PLD)
Other Intervention Name(s)
Doxorubicin Hydrochloride Liposome Injection
Intervention Description
PLD is an anthracycline topoisomerase II inhibitor that is encapsulated in liposomes for intravenous use.
Intervention Type
Drug
Intervention Name(s)
PD-1
Intervention Description
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.
Primary Outcome Measure Information:
Title
Disease control rate
Description
Disease control rate defined as confirmed complete response or partial response or stable disease under RECIST 1.0 criteria.
Time Frame
at least 10 months
Title
Objective response rate
Description
Objective response rate defined as confirmed complete response or partial response under RECIST 1.0 criteria.
Time Frame
at least 10 months
Secondary Outcome Measure Information:
Title
Progression free survival
Description
Progression-free survival estimated using Kaplan-Meier methods is defined as the time from registration to the earlier of death or disease progression.
Time Frame
at least 10 months
Title
Overall survival
Description
Overall survival estimated using Kaplan-Meier methods is defined as the time from treatment initiation to death by any cause
Time Frame
at least 10 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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. Exclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haitao Wang
Phone
(022)28331788
Email
peterrock2000@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lili Wang
Facility Information:
Facility Name
Tianjin Medical Unversity Second Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haitao Wang
First Name & Middle Initial & Last Name & Degree
Lili Wang
First Name & Middle Initial & Last Name & Degree
Dingkun Hou

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Pegylated Liposomal Doxorubicin, PD-1 in Treating Muscle Invasive Bladder Cancer

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