Lubiprostone Combined With Maintenance Therapy for Prevention of Postoperative Recurrence in Peritoneal Metastatic Colorectal Cancer

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.

Sex

All

Minimum age

18 Years

Maximum age

75 Years

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.