Irinotecan Liposomes in Total Neoadjuvant Therapy in Locally Advanced Rectal Cancer

NCT07074353 | Not Yet Recruiting Phase 3

• 1 other identifier: CinClare-2
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Locally Advanced Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Complete Response rate（CR）

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

  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)

  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.

Study Arms (2)

NALIRI-TNT

EXPERIMENTAL

Irinotecan Liposomes+Long-course concurrent chemoradiotherapy followed by consolidation chemotherapy

Drug: NALIRI; Radiation: LCRT; Drug: FOLFOX

TNT

PLACEBO COMPARATOR

Long-course concurrent chemoradiotherapy followed by consolidation chemotherapy

Radiation: LCRT; Drug: FOLFOX

Interventions

NALIRI DRUG

Irinotecan liposomes

NALIRI-TNT

LCRT RADIATION

Long-course concurrent chemoradiotherapy

NALIRI-TNT; TNT

FOLFOX DRUG

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

NALIRI-TNT; TNT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Location

MeSH Terms

Interventions

Folfox protocol

Central Study Contacts

Ji ZHU

CONTACT

0571-88128212; zhuji@zjcc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating Investigator

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 20, 2025
• Study Start: July 20, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): July 1, 2030
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)