Lubiprostone Combined With Maintenance Therapy for Prevention of Postoperative Recurrence in Peri… (NCT07405736) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Lubiprostone Combined With Maintenance Therapy for Prevention of Postoperative Recurrence in Peritoneal Metastatic Colorectal Cancer
124 participantsStarted 2026-02-24
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Voluntarily participates and provides written informed consent.
* Histologically confirmed colon/rectal adenocarcinoma with molecular status confirmed as pMMR or MSS.
* Cytoreductive surgery (CRS) achieves CC0/CC1 cytoreduction.
* No extraperitoneal metastasis prior to treatment.
* ECOG performance status 0-1 with adequate organ function per protocol requirements.
Exclusion Criteria:
* Extensive multisystem metastases on baseline imaging assessment.
* Tumor carrying BRAF V600E mutation.
* dMMR/MSI-H, or confirmed pathogenic POLE/POLD1 mutation(s).
* Cachexia or decompensated organ dysfunction.
* History of another malignancy within the past 5 years.
* Known or suspected hypersensitivity/allergy to the study drug or related formulations.
* Multiple primary cancers.
* Any serious disease or other medical, psychological, or social condition that, in the investigator's judgment, may compromise participant safety or affect study results.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
1-year Progression-Free Survival (PFS) Rate
Timeframe: From randomization to 12 months (1 year).