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New treatment option for Urinary Bladder Cancer
Official title Neoadjuvant Toripalimab in Combination with Gemcitabine and Cisplatin Therapy in Local Advanced Bladder Cancer Subjects
ClinicalTrials.gov ID: NCT04861584
What this study is testing
What is Neoadjuvant Toripalimab in Combination With Gemcitabine and Cisplatin?
Neoadjuvant Toripalimab in Combination With Gemcitabine and Cisplatin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for urinary bladder cancer.
Also referred to as Toripalimab.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a pre-surgical study involving subjects with local advanced bladder cancer, who are candidates for neoadjuvant therapy. It is a single-arm phase II portion.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patients between 18 and 75 years old on day of signing informed consent, regardless of gender;
- ECOG score 0-1 points, expected survival time\> 6 months;
- Pathologically confirmed locally advanced bladder urothelial carcinoma (cT2-T4a, N≤1, M0, tumor staging according to American Joint Committee on...
- Appropriate and plan for radical cystectomy;
- According to the RECIST1.1 standard, there is at least one measurable lesion (spiral CT scan ≥10mm);
You likely can't join if
- Have previously received anti-PD1/PDL1/CTLA-4 antibody treatment or systemic chemotherapy, bladder infusion chemotherapy is excluded;
- Have received bladder bacille Calmette Guerin (BCG) infusion therapy within 4 weeks;
- Have received radiotherapy of the bladder in the past;
- Patients with any history of active autoimmune disease or autoimmune disease;
- Complicated diseases that require the use of immunosuppressive drugs; concurrent diseases that require the use of immunosuppressive agents for...
- Combined with other malignant tumors;
See the full eligibility criteria
- Patients between 18 and 75 years old on day of signing informed consent, regardless of gender;
- ECOG score 0-1 points, expected survival time\> 6 months;
- Pathologically confirmed locally advanced bladder urothelial carcinoma (cT2-T4a, N≤1, M0, tumor staging according to American Joint Committee on Cancer (AJCC), 2017, eighth edition);
- Appropriate and plan for radical cystectomy;
- According to the RECIST1.1 standard, there is at least one measurable lesion (spiral CT scan ≥10mm);
- Since the diagnosis of locally advanced bladder urothelial carcinoma, patient has not received anti-tumor system treatment;
- The main organ functions are normal, and the following requirements must be met within 2 weeks before the first study treatment:
- Routine blood examination must meet: WBC≥4.0×109/L; PLT≥90×109/L; Hb≥90g/L (patients can be infused with red blood cells to meet this standard);
- Blood biochemical examination must meet: serum creatinine (Cr) ≤1.5 times the upper limit of normal (ULN) or endogenous creatinine clearance ≥60mL/min; TBIL≤1.5×ULN; ALB≥30g/L; ALT and AST≤ 3.0×ULN; TSH≤1.5×ULN.
- Female patients with fertility must undergo a pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and they voluntarily adopt appropriate methods of contraception during the...
- Agree to provide diagnosis and treatment-related tumor tissue specimens for clinical research, and have the ability to follow the planned research visit until the clinical recurrence/progress is clear.
- Sign informed consent voluntarily.
- Have previously received anti-PD1/PDL1/CTLA-4 antibody treatment or systemic chemotherapy, bladder infusion chemotherapy is excluded;
- Have received bladder bacille Calmette Guerin (BCG) infusion therapy within 4 weeks;
- Have received radiotherapy of the bladder in the past;
- Patients with any history of active autoimmune disease or autoimmune disease;
- Complicated diseases that require the use of immunosuppressive drugs; concurrent diseases that require the use of immunosuppressive agents for systemic or locally absorbable corticosteroids. It is forbidden to use...
- Combined with other malignant tumors;
- Have a history of allergy to other antibody drugs;
- The history of human immunodeficiency virus (HIV) infection;
- The subject has active infection, including active tuberculosis;
- Combined with severe heart disease, or combined with New York Heart Association (NYHA) grade 3 or 4 cardiac insufficiency;
- Kidney transplant patients;
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.