RecruitingPhase 2NCT07281157

Irinotecan Liposome Plus Capecitabine and Enronsubemab Combined With Short-course Radiotherapy for Neoadjuvant Treatment of Locally Advanced Rectal Cancer

The Combination of Irinotecan Liposome, Capecitabine and Enlansubemab Embedded in Short-course Radiotherapy as Neoadjuvant Therapy for Locally Advanced Rectal Cancer: a Prospective, Single-center and Single-arm Study


Sponsor

Tianjin Medical University Cancer Institute and Hospital

Enrollment

30 participants

Start Date

Nov 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective, single-center, single-arm study on the combination regimen of irinotecan liposome, capecitabine and enronsubemab embedded in short-course radiotherapy as neoadjuvant therapy for locally advanced rectal cancer.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a neoadjuvant (pre-surgery) combination of four treatments — a liposomal chemotherapy drug (irinotecan liposome), capecitabine (oral chemo), an immunotherapy drug (enronsubemab), and short-course radiation — for locally advanced rectal cancer. **You may be eligible if...** - You are 18–75 years old - You have locally advanced rectal cancer confirmed by biopsy (cT3–4 or lymph node positive), with the tumor within 10 cm of the anus - You have not received any prior cancer treatment for rectal cancer - Your tumor is measurable on scan - You are in good physical condition (ECOG 0–1) with at least 12 months expected survival - Your blood counts, liver, kidney, and clotting function are within acceptable limits **You may NOT be eligible if...** - You have had another cancer in the past 5 years (with some exceptions) - Your tumor is MSI-H or dMMR type (a subtype that responds differently to treatment) - You have significant bleeding, blood clots, or are on long-term anticoagulants - Your cancer has spread widely (e.g., to the lining of the abdominal cavity or multiple bones/brain) - You had major surgery in the past 4 weeks - You are pregnant or breastfeeding 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

DRUGIrinotecan Liposome, Capecitabine, and Enlansubemab Plus Short-Course Radiotherapy

Phase One: Induction immunotherapy Irinotecan liposome: 50mg/m2, ivgtt, d1; Capecitabine: 825mg/m2, po, bid, d1-10; Enlangsumab: 240mg, ivgtt, d1. Repeat every two weeks for two treatment cycles Phase Two: Short-course radiotherapy Short-course radiotherapy: 5x5Gy, once a day, 5Gy each time, for 5 consecutive days. After radiotherapy, rest for 7 to 14 days before starting consolidation immunotherapy. After radiotherapy, conduct imaging evaluations of tumor remission. Phase Three: Consolidation of chemotherapy-free treatment Irinotecan liposome: 50mg/m2, ivgtt, d1; Capecitabine: 825mg/m2, po, bid, d1-10; Enlangsumab: 240mg, ivgtt, d1. Repeat every two weeks for four treatment cycles Phase Four: W\&W


Locations(1)

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

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NCT07281157


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