BridgeMD
Tests treatment safety and results for Collecting Duct Carcinoma
Official title Study to Evaluate the Efficacy and Safety of Immunotherapy With Axitinib in Advanced Collecting Duct Carcinoma
ClinicalTrials.gov ID: NCT06211114
What this study is testing
What is PD-(L)1 inhibitor?
PD-(L)1 inhibitor is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for collecting duct carcinoma.
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 phase II trial to evaluate the efficacy and safety of immune checkpoint inhibitors in combination with axitinib for previously treated advanced collecting duct carcinoma.
- 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 80
You may be able to join if
- Fully understand and be willing to provide written informed consent.
- Male or female with age ≥ 18 years and \<80 years.
- Have received prior systemic therapy after previous metastasis for collecting duct carcinoma, histologically confirmed diagnosis of unresectable...
- Having at least one measurable disease per RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if re-progression...
- ECOG PS 0 or 1.
You likely can't join if
- Exclusion criteria: Patients with any of the following conditions will not be included in the study:
- Prior Anti-PD-1, PD-L1 or axitinib.
- Has participated or is currently participating in a trial of investigational agent within 4 weeks prior to the first dose of study treatment, unless...
- Had major surgery (judged by investigators) within 4 weeks prior to the first dose of study treatment or has not recovered from prior surgery.
- Has traditional Chinese medicine or Chinese patent medicine preparation with anti-cancer indication within 2 weeks prior to the first dose of study...
- Requiring corticosteroids (Prednisone \>10 mg/day or equivalent analogue) or other immunosuppressive agents within 2 weeks prior to the first dose of...
See the full eligibility criteria
- Fully understand and be willing to provide written informed consent.
- Male or female with age ≥ 18 years and \<80 years.
- Have received prior systemic therapy after previous metastasis for collecting duct carcinoma, histologically confirmed diagnosis of unresectable, recurrent or metastatic collecting duct carcinoma.
- Having at least one measurable disease per RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if re-progression has been demonstrated.
- ECOG PS 0 or 1.
- Adequate function of vital organs: 6.1 Bone marrow function (without blood or blood products transfusion, without hematopoietic stimulating factor or other medication to improve blood cell count within 2 days prior to...
- Being willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
- Female people of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first treatment dose. Female people of childbearing potential and male people whose partners are of...
- Exclusion criteria: Patients with any of the following conditions will not be included in the study:
- Prior Anti-PD-1, PD-L1 or axitinib.
- Has participated or is currently participating in a trial of investigational agent within 4 weeks prior to the first dose of study treatment, unless observational (non-treatment) clinical study or follow-up period of...
- Had major surgery (judged by investigators) within 4 weeks prior to the first dose of study treatment or has not recovered from prior surgery.
- Has traditional Chinese medicine or Chinese patent medicine preparation with anti-cancer indication within 2 weeks prior to the first dose of study treatment.
- Requiring corticosteroids (Prednisone \>10 mg/day or equivalent analogue) or other immunosuppressive agents within 2 weeks prior to the first dose of study treatment. 6. Patients without active autoimmune disease using...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, 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 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, 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.