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

NCT07474103•Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

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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

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Voluntary Participation: Subjects voluntarily participate in the study, sign the informed consent form, and have good compliance.
•Age and Gender: Age between 18 and 75 years, any gender.
•Pathological Diagnosis: Histologically or cytologically confirmed rectal adenocarcinoma; confirmed mismatch repair proficient (pMMR) or microsatellite stable (MSS) by genetic testing or immunohistochemistry.
•Disease Stage: Assessed as high-risk, mid-low (distance from the anal verge ≤10 cm) locally advanced rectal cancer by colonoscopy, digital rectal exam, or MRI. High-risk definition: Meeting at least one of the following: cT4, extramural vascular invasion (EMVI), tumor deposits, involvement of the mesorectal fascia or intersphincteric plane.
•Prior Treatment: No prior anti-tumor therapy for this rectal cancer (including surgery, radiotherapy, chemotherapy, immunotherapy, or targeted therapy).
•Measurable Lesion: At least one measurable lesion according to RECIST v1.1 criteria.
•Tumor Tissue Sample: Must provide tumor tissue samples for biomarker analysis.
•Adequate Organ Function (within 7 days before the first dose): 1) Hematological: Hemoglobin ≥90 g/L; White Blood Cell count ≥3.0 x 10⁹/L; Absolute Neutrophil Count ≥1.5 x 10⁹/L; Platelets ≥100 x 10⁹/L. 2) Hepatic: Total Bilirubin \<1.5 x ULN; AST and ALT ≤2.5 x ULN; Albumin ≥30 g/L. 3) Renal: Serum Creatinine ≤1.5 x ULN OR Creatinine Clearance ≥50 mL/min. 4) Coagulation: INR ≤1.5 x ULN (or ≤3 x ULN if on stable anticoagulant therapy); PTT or aPTT ≤1.5 x ULN (or ≤3 x ULN if on stable anticoagulant therapy).
•Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
•Life Expectancy: Expected survival time ≥3 months.
+2 more criteria

Exclusion Criteria

•Other Malignancies: Diagnosis of another malignancy within 5 years prior to the first dose, except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, carcinoma in situ, localized prostate cancer, or papillary thyroid cancer, etc.
•Allergy: Known or suspected allergy to the study drugs or any of their excipients.
•Pregnancy and Lactation: Pregnant or lactating women, or women planning to become pregnant during the study or within 6 months after the last dose.
•Central Nervous System Disease: Known active epilepsy, active central nervous system (CNS) metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease.
•Significant Cardiovascular Disease: Clinically significant uncontrolled cardiovascular disease.
•History of Allergic Disease: History of allergic diathesis, asthma, or atopic dermatitis.
•Pleural Effusion/Ascites: Presence of significant pleural effusion or ascites.
•Active Autoimmune Disease: Active autoimmune disease requiring systemic treatment within 2 years prior to the first dose (replacement therapy is allowed).
•Immunosuppressant Use: Use of systemic corticosteroids (\>10 mg/day prednisone equivalent) or other immunosuppressants within 2 weeks prior to enrollment.
•Interstitial Lung Disease: History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or evidence of active pneumonia on screening chest CT scan.
+5 more criteria

Locations (1)

Hongli Liu

Wuhan, China

Key Dates

Start Date

November 30, 2025

Primary Completion Date

March 31, 2028

Completion Date

December 31, 2028

Last Updated

March 16, 2026

Enrollment

ESTIMATED participants

Conditions

Rectal Cancer, Adenocarcinoma

Interventions

SCRT

RADIATION

Liposomal Irinotecan

DRUG

Oxaliplatin

DRUG

Capecitabine

DRUG

Sintilimab

DRUG

Contacts

Hongli Liu, Professor

CONTACT

13995680822 hongli_liu@hust.edu.cn

Induction Chemotherapy Plus Chemoradiotherapy With or Without Aspirin in High Risk Rectal Cancer

NCT03170115

Rectal Cancer, AdenocarcinomaLocally Advanced Malignant Neoplasm+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 16, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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