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Irinotecan Liposomes in Total Neoadjuvant Therapy in Locally Advanced Rectal Cancer

ConditionLocally Advanced Rectal Cancer
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhejiang Cancer Hospital

About this trial

This study enrolled patients with locally advanced rectal cancer. The experimental group received irinotecan liposomes combined with standard total neoadjuvant therapy (TNT), while the control group received standard TNT. The study endpoints were the complete response rate (cCR + pCR), 3-year event-free survival (EFS) rate, and overall survival (OS). The aim was to compare the efficacy and safety of irinotecan liposomes combined with or without standard TNT.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years and ≤ 75 years, both male and female are eligible;

Histologically confirmed rectal adenocarcinoma;

Clinical stage assessed by MRI as T3-4 or N+ (according to the 8th edition of the AJCC);

Distance from the lower edge of the tumor to the anal verge ≤ 10 cm;

Disqualifiers

Previous or ongoing treatment for rectal cancer, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.

Known MSI-H (high microsatellite instability) by genetic testing or dMMR (deficient mismatch repair) by immunohistochemistry.

Known hypersensitivity, allergic reaction, or contraindication to irinotecan liposomes/vehicle, irinotecan, other liposomal products, 5-FU, leucovorin, oxaliplatin, or any of these agents.

Uncontrolled cardiac symptoms or disease.

Trial design

Design model

Parallel

Treatments tested in this trial

  • NALIRI

    Drug

    Irinotecan liposomes

  • LCRT

    Radiation

    Long-course concurrent chemoradiotherapy

  • FOLFOX

    Drug

    Fluorouracil/Leucovorin, Oxaliplatin (5-FU/LV, OX)

Treatment groups

360 Participants
are divided into 2 treatment groups
Group A: NALIRI-TNTExperimental treatment 3 interventions
Group B: TNTPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Complete Response rate（CR）

Clinical Complete Response rate（cCR）+ Pathological Complete Response rate （pCR）

Time frame
cCR: before the surgery, and up to 4 weeks after the end of completation of total neoadjuvant therapy (TNT) for cCR. pCR: after the surgery.

Secondary outcomes

1

3-year event-free survival (3y-EFS)

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhejiang Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: