Neoadjuvant Chemoradiation With Nal-IRI and Capecitabine Guided by UGT1A1 Status in Patients With Rectal Cancer

Sponsor
Hebei Medical University Fourth Hospital
Study ID
NCT06210971
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • liposomal irinotecan — DRUG
    Liposomal irinotecan: 50mg/m\^2 or 70mg/m\^2
  • Capecitabine — DRUG
    Capecitabine: 625mg/m\^2 or 1000mg/m\^2 bid.
  • Radiation threapy — RADIATION
    50.4Gy/28 fractions

Study Details

This single-arm trial will explore the efficacy and safety of long-course neoadjuvant chemoradiation with liposomal irinotecan and capecitabine guided by UGT1A1 status in patients with locally advanced rectal cancer.

Key Dates

Start date
Feb 1, 2024
Status verified
Mar 2025
Primary completion
Feb 1, 2026
Completion
Jul 1, 2028

Study Design

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

Arms

  • Experimental: Liposomal irinotecan-based TNT therapy
    Concurrent Chemoradiotherapy (Radiation 50.4Gy/28 fractions + Capecitabine 625mg/m\^2 bid + Liposomal irinotecan 50mg/m\^2) followed by 4-6 cycles of Chemotherapy (Capecitabine 1000mg/m\^2 bid d1-7 + Liposomal irinotecan 70mg/m\^2 or 50mg/m\^2, d1, Q2W) before surgery.

Primary Outcome Measure

Pathologic Complete Response [ Time Frame: 1 week after sugery ]

Central Contacts

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