Actively Recruiting
NALIRI-XELOX+AK104 for First-line Treatment of Advanced PDAC
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2024-12-24
30
Participants Needed
1
Research Sites
141 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a single-center, Phase II Study to assess the efficacy and safety of the regimen of Nanoliposomal Irinotecan and XELOX (NALIRI-XELOX) in combination with Cadonilimab in subjects with advanced pancreatic ductal adenocarcinoma who have not previously received systemic treatment.
CONDITIONS
Official Title
NALIRI-XELOX+AK104 for First-line Treatment of Advanced PDAC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, male or female
- Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC)
- No prior systemic treatment for locally advanced or metastatic PDAC
- Presence of measurable disease according to RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 3 months
- Adequate organ function
- If female of childbearing potential, negative serum pregnancy test within 7 days before first treatment
- Willingness to use highly effective contraception from first treatment to 24 weeks after trial completion if applicable
You will not qualify if you...
- Untreated active central nervous system (CNS) metastasis or leptomeningeal metastasis
- Participation in another investigational drug study within 4 weeks or 5 half-lives prior to first treatment
- Receipt of other anti-tumor treatment within 4 weeks or 5 half-lives prior to first treatment
- Major surgery within 4 weeks prior to first treatment or incomplete recovery from such surgery
- Curative radiation within 3 months or radiation to more than 30% of bone marrow within 4 weeks prior to first treatment
- Use of immunosuppressive agents except for certain low-dose corticosteroids
- Vaccination within 28 days prior to first treatment, except inactivated vaccines
- Interstitial lung disease or history of pneumonitis requiring steroids
- History or active autoimmune disease that could worsen with immunostimulatory treatment
- Prior malignancy, uncontrolled illness, or severe hypersensitivity to antibody drugs
- Pregnancy or breastfeeding
- Other medical conditions impacting safety, efficacy, or compliance as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
L
lin yang
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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