Actively Recruiting
Nanoliposomal Irinotecan and XELOX NALIRI-XELOX Combined With Cadonilimab for First-Line Treatment of Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2024-12-24
30
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of Nanoliposomal Irinotecan and XELOX NALIRI-XELOX with Cadonilimab as a first-line treatment for patients with advanced pancreatic ductal adenocarcinoma PDAC who have not yet received systemic therapy. This Phase II, single-center study aims to assess the safety and effectiveness of this regimen in treating locally advanced or metastatic PDAC. The treatment involves cycles every two weeks including Nanoliposomal Irinotecan, Cadonilimab, Oxaliplatin, and Capecitabine, with specific dosing schedules. After three cycles, patients are re-evaluated, and those treated for more than nine cycles may enter maintenance therapy with Capecitabine and Cadonilimab. This approach studies continuous dosing and maintenance to manage advanced PDAC. Participants will undergo regular assessments including tumor response evaluations according to RECIST 1.1 criteria, safety monitoring for adverse events, and other efficacy measures like progression-free and overall survival over two years. Organ function, performance status, and other health indicators will be closely monitored to track treatment impact and patient safety throughout the study period.
CONDITIONS
Brief 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 per 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
- Negative serum pregnancy test within 7 days before first treatment for females of childbearing potential
- Willingness to use a highly effective method of contraception from first treatment to 24 weeks after trial completion for females of childbearing potential and males with partners of childbearing potential
You will not qualify if you...
- Untreated active central nervous system (CNS) or leptomeningeal metastasis
- Participation in another investigational drug study within 4 weeks or 5 times the drug half-life prior to trial treatment
- Receipt of other anti-tumor treatments within 4 weeks or 5 times the drug half-life prior to trial treatment
- Major surgery within 4 weeks prior to trial treatment or incomplete recovery from recent surgery
- Curative radiation within 3 months prior to trial treatment or radiation to over 30% of bone marrow within 4 weeks
- Current use of immunosuppressive agents unless tapered off prior to trial treatment, except low-dose corticosteroids for adrenal insufficiency
- Vaccination within 28 days prior to trial treatment, except inactivated vaccines
- Interstitial lung disease or history of pneumonitis requiring steroid treatment
- History or active autoimmune disease worsened by immunostimulatory agents
- Previous malignant disease, uncontrolled illness, prior therapy targeting T cell coregulatory proteins, or severe hypersensitivity to antibody drugs
- Pregnancy or breastfeeding
- Other medical conditions that may interfere with safety, efficacy, or compliance as determined by the investigator
Research Team
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