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Study to Evaluate the Efficacy and Safety of Immunotherapy With Axitinib in Advanced Collecting Duct Carcinoma

Study to Evaluate the Efficacy and Safety of Immune Checkpoint Inhibitors in Combination With Axitinib in Previously Treated Advanced Collecting Duct Carcinoma

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06211114
Enrollment
30
Registered
2024-01-18
Start date
2024-02-09
Completion date
2027-02-28
Last updated
2024-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Collecting Duct Carcinoma

Keywords

Immune Checkpoint Inhibitors, Axitinib

Brief 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.

Detailed description

Patients meeting specific inclusion and exclusion criteria will be enrolled in two stages, 8 patients in stage 1 and 22 patients in stage 2. Stage 2 will enroll if 1 or more patients exhibit a response at week 9 or later in stage 1 in the study. All enrolled patients will be treated with immune checkpoint inhibitors in combination with axitinib until disease progression. Efficacy will be assessed by tumor measurements using CT and MRI (when indicated) scans and physical exam at baseline, and scans and physical exam of all disease-involved areas every 9 weeks until progression. Safety will be assessed by periodic physical exams, clinical laboratory studies, and adverse events. All patients will have a follow-up visit 90 days following last study drug treatment.

Interventions

Toripalimab 240mg or Tirelizumab 200mg or pembrolizumab 200mg intravenously every 3 weeks

DRUGAxitinib

axitinib 5mg orally twice daily

Sponsors

Peking University Cancer Hospital & Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

1. Fully understand and be willing to provide written informed consent. 2. Male or female with age ≥ 18 years and \<80 years. 3. Have received prior systemic therapy after previous metastasis for collecting duct carcinoma, histologically confirmed diagnosis of unresectable, recurrent or metastatic collecting duct carcinoma. 4. 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. 5. ECOG PS 0 or 1. 6. 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 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. 6.4 Endocrine function: Normal thyroid stimulating hormone, or abnormal TSH whilst normal FT3 and FT4. 6.5 Coagulation function: International normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN, and activated partial thromboplastin time (aPTT) ≤1.5×ULN, Subjects receiving anticoagulant therapy (e.g., heparin or warfarin) may participate in the study with PT or APTT levels within the scope of the proposed therapy and monitored during study treatment. 6.6 Left ventricular ejection fraction (LVEF) ≥ 50%. 7. Being willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. 8. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first treatment dose. Female subjects of childbearing potential and male subjects whose partners are of childbearing potential must agree to use a highly effective methods of contraceptive throughout the study and for 180 days after the last dose of study therapy.

Design outcomes

Primary

MeasureTime frameDescription
ORR assessed by investigators per RECIST 1.1Up to approximately 2 yearsThe treatment effect of with ICI plus axitinib will be assessed using RECIST 1.1 to determine tumor response.

Secondary

MeasureTime frameDescription
PFS assessed by investigators per RECIST 1.1Up to approximately 2 yearsThe treatment effect of with ICI plus axitinib will be assessed using RECIST 1.1 to determine tumor response.

Countries

China

Contacts

Primary ContactXinan Sheng, MD.
doctor_sheng@126.com+86-10-88196348

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026