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

Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study ID
NCT06405490
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Apr 17, 2024
Status verified
Dec 2024
Primary completion
Aug 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: NALIRI-XELOX+AK104
    Every 2 weeks as a cycle: 1. Nanoliposomal Irinotecan: 47.1mg/m2, iv, d1; 2. Cadonilimab: 6mg/kg, iv, d3; 3. Oxaliplatin: 70mg/m2, iv, d1; 4. Capecitabine: 1000mg/m2, bid, po, d1-d7; Re-evaluate patients every three cycles. If the patient has been treated for more than 9 cycles, they will enter maintenance therapy, and the regimen is capecitabine +Cadonilimab.

Primary Outcome Measure

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

Central Contacts

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