NCT07405736Not yet recruitingPhase 2
Lubiprostone Combined With Maintenance Therapy for Prevention of Postoperative Recurrence in Peritoneal Metastatic Colorectal Cancer
Lubiprostone Combined With Maintenance Therapy for Prevention of Postoperative Recurrence in Peritoneal Metastatic Colorectal Cancer, A Randomized Controlled Phase II Study
Source: ClinicalTrials.gov · Last updated 12 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 124 (estimated)
- First submitted
- 4 Feb 2026
- Start date
- 24 Feb 2026
- Primary completion date
- 1 Jun 2027
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Colorectal cancer
- NCT number
- NCT07405736
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 124
- From 24 Feb 2026 to the primary completion date, 1 Jun 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.