Actively Recruiting
Nanoliposomal Irinotecan and XELOX Combined with Cadonilimab for First Treatment of Advanced Pancreatic Ductal Adenocarcinoma A Single-Arm Phase II Study
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
Researchers are evaluating the safety and effectiveness of a drug combination called Nanoliposomal Irinotecan and XELOX (NALIRI-XELOX) together with Cadonilimab for treating advanced pancreatic ductal adenocarcinoma in patients who have not received previous systemic treatment. This is a Phase II, single-center study focusing on patients with locally advanced or metastatic pancreatic cancer. Participants will receive a regimen that includes Nanoliposomal Irinotecan, Oxaliplatin, Capecitabine, and Cadonilimab. These medications will be given regularly as part of the treatment plan. The study involves only one group receiving this combination, aiming to assess the response rate and safety over time. During the study, patients will undergo assessments to measure how the cancer responds to the treatment, including imaging based on standard criteria (RECIST 1.1). Safety and organ function will be monitored, and participants must meet specific health and performance standards to join. The main outcome measured is the Objective Response Rate over two years, reflecting the proportion of patients whose tumors shrink or disappear with 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
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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
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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