Study to Evaluate the Efficacy and Safety of Immunotherapy With Axitinib in Advanced Collecting D… (NCT06211114) | Clinical Trial Compass
RecruitingPhase 2
Study to Evaluate the Efficacy and Safety of Immunotherapy With Axitinib in Advanced Collecting Duct Carcinoma
China30 participantsStarted 2024-02-09
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion 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:
✓.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 first dose of study drug): Absolute neutrophil count (ANC) ≥ 1.5×109/L. Platelets ≥ 100×109/L. Hemoglobin ≥ 9.0g/dL or ≥ 5.6mmol/L. 6.2 Renal function: Serum creatinine ≤ 1.5×ULN 6.3 Hepatic function:Serum total bilirubin ≤1.5×ULN or total bilirubin levels \>1.5×ULN with direct bilirubin ≤ ULN. AST and ALT ≤2.5 × ULN, ≤5×ULN in those with hepatic metastasis.
✓.4 Endocrine function: Normal thyroid stimulating hormone, or abnormal TSH whilst normal FT3 and FT4.
Exclusion criteria
✕. 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-interventional) clinical study or follow-up period of interventional study.
What they're measuring
1
ORR assessed by investigators per RECIST 1.1
Timeframe: Up to approximately 2 years
Trial details
NCT IDNCT06211114
SponsorPeking University Cancer Hospital & Institute
✕. 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 inhaled prednisone \>10 mg/day will not be excluded from the study.