NALIRI-XELOX+AK104 for First-line Treatment of Advanced PDAC

Official title

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

Overview

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.

Interventions

• Drug Nanoliposomal Irinotecan+Oxaliplatin +Capecitabine+Cadonilimab
  Use the above medications on a regular basis

Primary outcome measures

• Objective Response Rate (ORR) [Time frame: 2 years]

Secondary outcome measures (6)

• Duration of Response (DoR) [Time frame: 2 years]
• Disease Control Rate (DCR) [Time frame: 2 years]
• Median Progression-Free Survival (mPFS) [Time frame: 1 years]
• 12-month PFS rate [Time frame: 12 months]
• Median Overall Survival (mOS) [Time frame: 2 years]
• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Adverse Events (AEs) Incidence, Serious Adverse Events (SAE) Incidence [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

• Age ≥18, male or female;
• Has histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC);
• Has not received prior systemic treatment for their locally advanced or metastatic PDAC;
• Has presence of measurable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST 1.1);
• Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status;
• Has a life expectancy of at least 3 months;
• Has adequate organ function;
• If female of childbearing potential, have a negative serum pregnancy test within 7 days prior to first trial treatment;
• 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

• Untreated active CNS metastasis or leptomeningeal metastasis.
• 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;
• 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;
• 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;
• 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;
• 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);
• Vaccination within 28 days of the first administration of trial treatment, except for administration of inactivated vaccines (e.g., inactivated influenza vaccines);
• Has interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management;
• History or current active autoimmune disease that might deteriorate when receiving an immunostimulatory agent；
• 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；
• Is pregnant or breastfeeding;
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences — Beijing

Identifiers

NCT: NCT06405490 · NCC4398

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗