A Phase 2 interventional study of liposomal irinotecan and Capecitabine in Rectal Cancer, sponsored by Hebei Medical University Fourth Hospital. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by Hebei Medical University Fourth Hospital · Phase 2, Interventional, and Treatment
This single-arm trial will explore the efficacy and safety of long-course neoadjuvant chemoradiation with liposomal irinotecan and capecitabine guided by UGT1A1 status in patients with locally advanced rectal cancer.
This is a single-center, single-arm, prospective clinical study. The aim of this study is to explore the short-term and long-term efficacy and safety of total neoadjuvant therapy with irinotecan liposome in patients with locally advanced rectal cancer. Patients' nutritional status, quality of life, changes in symptoms, and adverse events will also be regularly assessed and registered during the implementation phase of the study, and patients will be treated promptly if symptoms are assessed as positive.
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's enrollment of 60 is close to the median of 65 across 1,297 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Hebei Medical University Fourth Hospital is the lead sponsor of 78 studies on the registry; 53 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Concurrent Chemoradiotherapy (Radiation 50.4Gy/28 fractions + Capecitabine 625mg/m\^2 bid + Liposomal irinotecan 50mg/m\^2) followed by 4-6 cycles of Chemotherapy (Capecitabine 1000mg/m\^2 bid d1-7 + Liposomal irinotecan 70mg/m\^2 or 50mg/m\^2, d1, Q2W) before surgery.
Drug: liposomal irinotecan · Drug: Capecitabine · Radiation: Radiation threapy
Liposomal irinotecan: 50mg/m\^2 or 70mg/m\^2
Also known as: nal-IRI
Capecitabine: 625mg/m\^2 or 1000mg/m\^2 bid.
Also known as: Xeloda
50.4Gy/28 fractions
Also known as: RT
Pathologic Complete Response
Defined as the proportion of patients who have achieved pathologic complete response.
Time frame: 1 week after sugery
clinical complete response
Defined as the proportion of patients who have achieved clinical complete response.
Time frame: up to 30 weeks
Major Pathologic Response
Defined as the proportion of patients who have achieved major pathologic response
Time frame: 1 week after sugery
Objective Response Rate
Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1.
Time frame: through study completion，an average of 3 year
Anal Sphincter Retention Rate
Defined as the proportion of patients who retain anal sphincter
Time frame: 1 week after sugery
R0 resection rate
Defined as the proportion of patients who have achieved R0 resection.
Time frame: 1 week after sugery
3-year Local Recurrence Free Survival Rate
Defined as the proportion of patients who are not local recurrence or death at 3 years after enrollment.
Time frame: 3 years
3-year Progress Free Survival Rate
Defined as the proportion of patients who are not progress or death at 3 years after enrollment.
Time frame: 3 years
3-year Overall Survival Rate
Defined as the proportion of patients who are alive at 3 years after enrollment.
Time frame: 3 years
Incidence of adverse events
Use NCI-CTCAE version 5.0 for classification and grading.
Time frame: 7 months
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Hebei Medical University Fourth Hospital