SCRT-NALIRIXELOX+Sintilimab as TNT for High-Risk LARC

Sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study ID
NCT07474103
Status
Recruiting
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Conditions

  • Rectal Cancer, Adenocarcinoma

Eligibility Criteria

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

Interventions

  • SCRT — RADIATION
    25 Gy / 5 F
  • Liposomal Irinotecan — DRUG
    50 mg/m², intravenously (IV) on Day 1 of each cycle.
  • Oxaliplatin — DRUG
    85 mg/m², IV on Day 1 of each cycle.
  • Capecitabine — DRUG
    800 mg/m², orally twice daily from Day 1 to Day 14 of each cycle.
  • Sintilimab — DRUG
    200 mg, IV on Day 1 of each cycle.

Study Details

This is a single-center, exploratory clinical study for patients with newly diagnosed, high-risk, locally advanced rectal cancer. The study aims to evaluate the effectiveness and safety of a comprehensive pre-surgery (neoadjuvant) treatment strategy. All participants will receive a short course of radiation therapy (25 Gy in 5 fractions) over one week. This will be followed by a combination of chemotherapy (Liposomal Irinotecan, Oxaliplatin, and Capecitabine) and immunotherapy (Sintilimab). This combined treatment is administered for six cycles. For patients who achieve a complete response, the option to avoid immediate surgery and enter a close monitoring program ("Watch and Wait") will be considered.

Key Dates

Start date
Nov 30, 2025
Status verified
Nov 2025
Primary completion
Mar 31, 2028
Completion
Dec 31, 2028

Study Design

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

Arms

  • Experimental: SCRT followed by NALIRIXELOX + Sintilimab
    1. Short-Course Radiotherapy (SCRT) 2. Systemic Therapy (Chemotherapy + Immunotherapy): Liposomal Irinotecan+Oxaliplatin+Capecitabine+Sintilimab

Primary Outcome Measure

Complete Response Rate [ Time Frame: 6 months ]

Central Contacts