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Liposomal Irinotecan, Capecitabine, and Enlonstobart Combined With Short-Course Radiotherapy as Neoadjuvant Therapy for Locally Advanced Rectal Cancer: A Prospective, Single-Center, Single-Arm Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a prospective, single-center, single-arm study evaluating the combination regimen of liposomal irinotecan, capecitabine, and enlonstobart combined with short-course radiotherapy as neoadjuvant therapy for locally advanced rectal cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Age of 18-75 years old;

• rectal adenocarcinoma confirmed by histology and/or cytology;

• locally advanced rectal cancer cT3-4 or N+ confirmed by baseline examination (AJCC/UICC TNM staging (8th edition, 2017);

• Distance from lower margin to anal margin ≤ 10 cm;

• Patients with at least one assessable lesion according to RECIST1.1 criteria;

• ECOG 0-1;

• the expected survival time was more than 12 months;

• had not received anti-tumor treatment for rectal cancer after diagnosis, including radiotherapy, chemotherapy, surgery, etc.

• Bone marrow function: absolute neutrophil count (ANC) ≥1.5×10\^9/L, hemoglobin ≥90g/dL, platelet (PLT) ≥100×10\^9/L, white blood cell (WBC) ≥3.0×10\^9/L;

⁃ Liver function: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) ≤2.5 times the upper limit of normal (ULN), if there is liver metastasis ≤5×ULN, total bilirubin \<1.5 ULN;

⁃ Renal function: serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CCr) ≥60mL/min (according to Cockcroft-Gault formula);

⁃ Coagulation function: prothrombin time (PT), activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤1.5×ULN;

⁃ exclude active or suspected infection;

⁃ non-pregnant or lactating women; Women/men of childbearing age should use effective contraception during the study and for 6 months after the end of study treatment;

⁃ The patients had good compliance, understood the research process of this study, and signed the written informed consent.

Locations
Other Locations
China
Tianjin Medical University Cancer Institute & Hospital
RECRUITING
Tianjin
Contact Information
Primary
Rui Liu, MD
liurui9003@163.com
+86 13602139003
Time Frame
Start Date: 2025-11-01
Estimated Completion Date: 2032-04-30
Participants
Target number of participants: 30
Treatments
Experimental: Liposomal Irinotecan, Capecitabine, and Enlonstobart Combined with Short-Course Radiotherapy
Related Therapeutic Areas
Sponsors
Leads: Tianjin Medical University Cancer Institute and Hospital

This content was sourced from clinicaltrials.gov