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

NCT07474103 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2026-03-16

No results posted yet for this study

Summary

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.

Conditions

  • Rectal Cancer, Adenocarcinoma

Interventions

RADIATION

SCRT

25 Gy / 5 F

DRUG

Liposomal Irinotecan

50 mg/m², intravenously (IV) on Day 1 of each cycle.

DRUG

Oxaliplatin

85 mg/m², IV on Day 1 of each cycle.

DRUG

Capecitabine

800 mg/m², orally twice daily from Day 1 to Day 14 of each cycle.

DRUG

Sintilimab

200 mg, IV on Day 1 of each cycle.

Sponsors & Collaborators

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    lead OTHER

Principal Investigators

  • Hongli Liu, Professor · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-30
Primary Completion
2028-03-31
Completion
2028-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07474103 on ClinicalTrials.gov