Irinotecan Liposomes in Total Neoadjuvant Therapy in Locally Advanced Rectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NALIRI, LCRT, FOLFOX.
- Who it may be relevant to
- Registry conditions: Locally Advanced Rectal Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized, Multicenter Clinical Study of Irinotecan Liposomes in Total Neoadjuvant Therapy in Locally Advanced Rectal Cancer
Overview
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.
Interventions
- Drug NALIRI
Irinotecan liposomes - Radiation LCRT
Long-course concurrent chemoradiotherapy - Drug FOLFOX
Fluorouracil/Leucovorin, Oxaliplatin (5-FU/LV, OX)
Primary outcome measures
- Complete Response rate（CR） [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 outcome measures (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.]
Eligibility criteria
Inclusion criteria
- 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;
- ECOG (Eastern Cooperative Oncology Group) performance status of 0-1;
- UGT1A1\*6 and UGT1A1\*28 gene phenotypes are either wild-type (GG+6/6) or single-site mutant (GG+6/7 or GA+6/6);
- No prior anti-tumor treatment for rectal cancer, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.;
- Normal function of major organs.
Exclusion criteria
- 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.
- Severe infection (CTCAE > Grade 2) within 4 weeks prior to the first use of the study drug, such as severe pneumonia requiring hospitalization, bacteremia, or infectious complications; baseline chest imaging showing active pulmonary inflammation; signs and symptoms of infection within 14 days prior to the first use of the study drug or requiring oral or intravenous antibiotic therapy, excluding prophylactic use of antibiotics.
- Severe gastrointestinal dysfunction (inflammation or diarrhea greater than Grade 1).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Zhejiang Cancer Hospital — Hangzhou
Identifiers
NCT: NCT07074353 · CinClare-2