RecruitingNot ApplicableNCT07474103

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

Short-Course Radiotherapy Followed by Liposomal Irinotecan, Oxaliplatin, Capecitabine, and Sintilimab as Total Neoadjuvant Therapy in High-Risk Locally Advanced Rectal Cancer: A Single-Arm, Single-Center, Exploratory Study


Sponsor

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

Enrollment

49 participants

Start Date

Nov 30, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination treatment for locally advanced rectal cancer (cancer in the last part of the large intestine that has grown into nearby tissue but not spread to distant organs). The treatment combines short-course radiation, chemotherapy drugs (including a newer drug called nalirixelox), and an immunotherapy drug (sintilimab), given before surgery. **You may be eligible if...** - You are between 18 and 75 years old - You have been confirmed to have rectal cancer (adenocarcinoma) that is locally advanced and high-risk - Your tumor is located within 10 cm of the anal opening - You have not had any prior treatment for this cancer - Your tumor tests show it is not the type that responds to immunotherapy alone (pMMR/MSS) - Your blood counts and organ function are adequate - You are in good general health (ECOG 0 or 1) **You may NOT be eligible if...** - You have another active cancer diagnosed in the last 5 years - You are pregnant or breastfeeding - You have cancer that has spread to the brain or spinal fluid - You have an active autoimmune disease requiring treatment - You have had a major operation in the last 4 weeks - You have active HIV, hepatitis B, hepatitis C, or tuberculosis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONSCRT

25 Gy / 5 F

DRUGLiposomal Irinotecan

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

DRUGOxaliplatin

85 mg/m², IV on Day 1 of each cycle.

DRUGCapecitabine

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

DRUGSintilimab

200 mg, IV on Day 1 of each cycle.


Locations(1)

Hongli Liu

Wuhan, China

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NCT07474103


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