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

NCT07405736 | Not Yet Recruiting Phase 2

• 1 other identifier: 2025-FXY-439
• Study Type: interventional
• Target: 124
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Colorectal Cancer Metastatic; Peritoneal Metastasis; Colorectal Cancer (CRC); MSS Metastatic Colorectal Cancer; Peritoneal (Metastatic) Cancer

Keywords

Peritoneal metastasis; Colorectal cancer; Maintenance therapy; Lubiprostone; Cytoreductive Surgery; Progression-free survival

Outcome Measures

Primary Outcomes (1)

• 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.

  From randomization to 12 months (1 year).

Secondary Outcomes (5)

• 3-year Progression-Free Survival (PFS) rate

  From randomization to 36 months (3 years).

• 3-year Overall Survival (OS) Rate

  From randomization to 36 months (3 years).

• Extraperitoneal (Distant) Metastasis Rate

  Up to 36 months (3 years) after randomization.

• Treatment Toxicity (Adverse Events)

  From start of study treatment through 30 days after the end of treatment.

• Quality of Life Evaluated by EORTC QLQ-C30 v3.0

  Baseline; every 3 months during treatment; and at end of follow-up (up to 36 months).

Study Arms (2)

Investigator-Selected Maintenance Therapy + Lubiprostone

EXPERIMENTAL

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.

Drug: maintenance therapy plus lubiprostone

Investigator-Selected Maintenance Therapy

ACTIVE COMPARATOR

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.

Drug: maintenance therapy

Interventions

maintenance therapy plus lubiprostone DRUG

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.

Investigator-Selected Maintenance Therapy + Lubiprostone

maintenance therapy DRUG

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.

Investigator-Selected Maintenance Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

MeSH Terms

Conditions

Neoplasm Metastasis; Neoplasms; Colorectal Neoplasms

Interventions

Maintenance; Lubiprostone

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services; Alprostadil; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Central Study Contacts

Guangzhao Lv, MD, PhD

CONTACT

+86 020 87343920; lvgz@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Colorectal Surgery; Professor

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 12, 2026
• Study Start: February 24, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share