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

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,

Trial Details

NCT ID
NCT07474103
Phase
NA
Sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • SCRT
  • Liposomal Irinotecan
  • Oxaliplatin
  • Capecitabine
  • Sintilimab
Locations (sample)
  • Wuhan, China|30.58333,114.26667

Key Eligibility 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 microsatell…
  • Disease Stage: Assessed as high-risk, mid-low (distance from the anal verge ≤10 cm) locally advanced rectal cancer by colonoscopy, digital rectal e…

For full eligibility, visit ClinicalTrials.gov.

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