Liposomal Irinotecan, Capecitabine and Enlonstobart With Short-Course Radiotherapy for Locally Advanced Rectal Cancer

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT07281157
Phase
PHASE2
Status
Recruiting
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Conditions

  • Advanced Rectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan Liposome, Capecitabine, and Enlansubemab Plus Short-Course Radiotherapy — DRUG
    Phase One: Induction immunotherapy Liposomal irinotecan: 50mg/m2, ivgtt, d1; Capecitabine: 825mg/m2, po, bid, d1-10; Enlonstobart: 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 Liposomal irinotecan: 50mg/m2, ivgtt, d1; Capecitabine: 825mg/m2, po, bid, d1-10; Enlonstobart: 240mg, ivgtt, d1. Repeat every two weeks for four treatment cycles Phase Four: W\&W

Study Details

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.

Key Dates

Start date
Nov 1, 2025
Status verified
Oct 2025
Primary completion
Apr 30, 2027
Completion
Apr 30, 2032

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Liposomal Irinotecan, Capecitabine, and Enlonstobart Combined with Short-Course Radiotherapy

Primary Outcome Measure

Complete response plus pathological complete response [ Time Frame: 1 year ]

Central Contacts