Combination treatment for advanced pancreatic cancer

Nanoliposomal Irinotecan and XELOX (NALIRI-XELOX) in Combination With Cadonilimab for First-Line Treatment of Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma : A Single-arm, Phase II Study

This study is testing a new combination of treatments for people with advanced pancreatic cancer who haven't had treatment before to see if it helps manage their disease better.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Academic / other)
• Drugs / interventions: radiation, prednisone, Cadonilimab
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06405490 on ClinicalTrials.gov

What this trial studies

This Phase II clinical trial evaluates the safety and efficacy of a combination treatment regimen consisting of Nanoliposomal Irinotecan, Oxaliplatin, Capecitabine, and Cadonilimab for patients with advanced pancreatic ductal adenocarcinoma who have not previously received systemic therapy. The study aims to determine how well this treatment works in managing the disease and improving patient outcomes. Participants will be monitored for measurable disease response based on established criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with confirmed advanced pancreatic ductal adenocarcinoma who have not undergone prior systemic treatment.

Not a fit: Patients with untreated active central nervous system metastasis may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced pancreatic cancer.

How similar studies have performed: While there have been studies on similar treatment combinations, this specific regimen is being evaluated for the first time in this context.

Eligibility criteria

Inclusion Criteria:

1. Age ≥18, male or female;
2. Has histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC);
3. Has not received prior systemic treatment for their locally advanced or metastatic PDAC;
4. Has presence of measurable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST 1.1);
5. Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status;
6. Has a life expectancy of at least 3 months;
7. Has adequate organ function;
8. If female of childbearing potential, have a negative serum pregnancy test within 7 days prior to first trial treatment;
9. If female of childbearing potential or a male subject with a partner with childbearing potential, be willing to use a highly effective method of contraception (with a failure rate of less than 1.0% per year) from first study treatment to 24 weeks after completion of the trial treatment.

Exclusion Criteria:

1. Untreated active CNS metastasis or leptomeningeal metastasis.
2. Is currently participating and receiving an investigational drug or has participated in a study of an investigational drug within 4 weeks or within 5 times of half-life (no less than 2 weeks), whichever is shorter prior to the first dose of trial treatment;
3. Has received other anti-tumor treatment within 4 weeks or within 5 times of half-life (no less than 2 weeks), whichever is shorter prior to the first trial treatment;
4. Major surgery for any reason, except diagnostic biopsy, within 4 weeks of the first administration of trial treatment and/or if the subject has not fully recovered from the surgery within 4 weeks of the first administration of trial treatment;
5. Curative radiation within 3 months of the first dose of trial treatment. Radiation to more than 30% of the bone marrow or with a wide field of radiation should not be used within 4 weeks prior to the first administration of trial treatment;
6. Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of trial treatment (with the exception of subjects with adrenal insufficiency, who may continue corticosteroids at physiologic replacement doses, equivalent to \< 10 mg prednisone daily, inhaled steroids and topical use of steroids);
7. Vaccination within 28 days of the first administration of trial treatment, except for administration of inactivated vaccines (e.g., inactivated influenza vaccines);
8. Has interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management;
9. History or current active autoimmune disease that might deteriorate when receiving an immunostimulatory agent；
10. Previous malignant disease History of uncontrolled intercurrent illness Prior therapy with any antibody/drug targeting T cell coregulatory proteins Known severe hypersensitivity reactions to antibody drug；
11. Is pregnant or breastfeeding;
12. Other medical conditions that at the discretion of investigator interfere with the requirements of the trial in terms of safety or efficacy evaluation, or treatment compliance.

Where this trial is running

Beijing, Beijing Municipality

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: lin yang

Conditions Nanoliposomal Irinotecan; Cadonilimab; Oxaliplatin; Capecitabine; First-Line; Advanced Cancer; Pancreatic Adenocarcinoma; Drug Use