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.
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.
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.
Parallel
maintenance therapy plus lubiprostone
DrugIn 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
DrugIn 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.
1-year Progression-Free Survival (PFS) Rate
Progression-free survival is defined as the time from randomization to the first documented recurrence/progression event. Recurrence/progression is confirmed by at least one of the following: imaging assessment judged as recurrence by two radiologists; or physical examination + progressively rising tumor markers and/or MRD and other objective evidence supporting progression; or positive cytology/histology from biopsy. The date of recurrence is the date the above diagnostic confirmation is established; isolated CEA rise alone is not sufficient evidence of recurrence.
3-year Progression-Free Survival (PFS) rate
PFS is defined as the time from randomization to the first documented recurrence/progression event, using the same event confirmation rules as above (radiology/clinical objective evidence/positive pathology). Tumor assessments are performed at scheduled intervals (every 3 months or 6 months) and/or whenever clinical signs suggest progression.
3-year Overall Survival (OS) Rate
Overall survival is defined as the time from randomization to death from any cause. Participants alive at the last follow-up are censored on that date.
Extraperitoneal (Distant) Metastasis Rate
Proportion of participants who develop metastasis outside the peritoneum (extraperitoneal organs/tissues) during follow-up, confirmed by imaging and/or pathology.
Treatment Toxicity (Adverse Events)
Treatment-emergent adverse events graded and recorded according to NCI CTCAE v5.0, with emphasis on the incidence of Grade ≥3 adverse events.
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