Actively Recruiting
Study to Evaluate the Efficacy and Safety of Immunotherapy With Axitinib in Advanced Collecting Duct Carcinoma
Led by Peking University Cancer Hospital & Institute · Updated on 2024-11-26
30
Participants Needed
2
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study to Evaluate the Efficacy and Safety of Immunotherapy With Axitinib in Advanced Collecting Duct Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to fully understand and willing to provide written informed consent
- Male or female aged 18 years or older and younger than 80 years
- Histologically confirmed unresectable, recurrent or metastatic collecting duct carcinoma with prior systemic therapy after metastasis
- At least one measurable tumor lesion according to RECIST 1.1 criteria
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
- Adequate vital organ function including bone marrow, renal, hepatic, endocrine, coagulation, and heart function
- Willing and able to comply with study visits, treatment plan, lab tests, and procedures
- Female participants of childbearing potential must have a negative pregnancy test within 7 days before first treatment
- Both female participants of childbearing potential and male participants with partners of childbearing potential must agree to use highly effective contraception during the study and for 180 days after last treatment
You will not qualify if you...
- Prior treatment with Anti-PD-1, PD-L1, or axitinib
- Participation in investigational drug trials within 4 weeks before first dose, except observational or follow-up studies
- Major surgery within 4 weeks before first dose or not fully recovered from prior surgery
- Use of traditional Chinese medicine with anti-cancer effects within 2 weeks before first dose
- Use of corticosteroids (>10 mg Prednisone or equivalent) or other immunosuppressive drugs within 2 weeks before first dose
- History of organ transplantation or long-term corticosteroid treatment
- Certain controlled endocrine disorders such as hypothyroidism only on replacement therapy
- Unrecovered toxicity from previous anti-cancer treatment except alopecia
- Additional malignancy requiring treatment within 5 years, with exceptions for certain low-risk cancers
- Active or recent central nervous system metastasis within 30 days prior to first dose
- Poorly controlled hypertension
- Serious cardiovascular events within 6 months prior to randomization
- Active hemorrhage or significant bleeding within 30 days prior to randomization
- Recent deep vein thrombosis or pulmonary embolism within 6 months
- Arterial thrombosis within 12 months prior to randomization
- Significant gastrointestinal abnormalities affecting drug absorption or active GI bleeding
- History or current non-infective pneumonia or interstitial lung disease requiring steroids
- Active infection requiring systemic therapy or known HIV, HBV, or HCV infection not meeting criteria
- Receipt of live virus vaccine within 30 days before randomization
- History of hypersensitivity to antibodies or tyrosine kinase inhibitors
- Known psychiatric disorders or drug abuse
- Evidence of inadequate wound healing
- Use or expected need for strong CYP3A4/5 inhibitors or inducers or proarrhythmic drugs within 7 days of randomization
- Any condition or abnormality that might interfere with study participation or results as judged by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Department of Genitourinary Oncology, Peking University Cancer Hospital & Institute
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
2
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100086
Not Yet Recruiting
Research Team
X
Xinan Sheng, MD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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