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Lubiprostone Combined With Maintenance Therapy for Prevention of Postoperative Recurrence in Peritoneal Metastatic Colorectal Cancer
Sponsor: Sun Yat-sen University
Summary
The goal of this phase II randomized controlled clinical trial is to evaluate whether adding lubiprostone to standard postoperative maintenance therapy can delay disease progression and recurrence in adult patients with colorectal cancer and peritoneal metastases (PM-CRC) who have undergone cytoreductive surgery with or without HIPEC after systemic treatment. The main questions it aims to answer are: Does lubiprostone plus maintenance therapy improve the 1-year progression-free survival (PFS) rate compared with maintenance therapy alone? Is lubiprostone safe and feasible for long-term use during the maintenance period in this PM-CRC population? Researchers will compare lubiprostone + maintenance therapy versus maintenance therapy alone to see if the addition of lubiprostone prolongs PFS, reduces the risk of distant metastasis, improves overall survival, and maintains or improves quality of life. Participants will: Be randomly assigned to receive maintenance therapy with lubiprostone or maintenance therapy alone after surgery (CRS ± HIPEC) and prior systemic therapy, according to the study protocol. Undergo scheduled follow-up assessments for disease status (progression/recurrence), survival outcomes, treatment-related toxicity, and quality of life using the EORTC QLQ-C30 (v3.0) questionnaire.
Official title: Lubiprostone Combined With Maintenance Therapy for Prevention of Postoperative Recurrence in Peritoneal Metastatic Colorectal Cancer, A Randomized Controlled Phase II Study
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
124
Start Date
2026-02-24
Completion Date
2028-06-01
Last Updated
2026-02-12
Healthy Volunteers
No
Conditions
Interventions
maintenance therapy plus lubiprostone
In experiment arm, participants receive investigator-selected standard-of-care maintenance therapy plus lubiprostone (24 μg orally twice daily) during the maintenance period, until disease progression, unacceptable toxicity, withdrawal, or other protocol-defined discontinuation criteria.
maintenance therapy
In active comparator arm, participants receive investigator-selected standard-of-care maintenance therapy during the maintenance period, until disease progression, unacceptable toxicity, withdrawal, or other protocol-defined discontinuation criteria.