Conversion Surgery for Gastric Cancer With Peritoneal Metastases (CONVERGENCE) (CONVERGENCE)

May 12, 2026 updated by: National University Hospital, Singapore

The goal of this clinical trial is to evaluate the impact of conversion surgery on overall survival (OS) in patients with gastric cancer peritoneal metastases (GCPM) who show a good response to preoperative systemic therapy (including first-line chemotherapy with or without targeted therapy and/or immunotherapy) with or without peritoneal-directed chemotherapy.]. The main question it aims to answer is:

(i) Will Conversion surgery be associated with improved overall survival (OS) in patients with GCPM who respond well to preoperative systemic therapy, compared to patients who do not undergo surgery? (ii) Will Quality of life be comparable or improved in patients who undergo conversion surgery compared to patients receiving palliative chemotherapy as measured by the QLQ-C30 questionnaire?

If there is a comparison group: Researchers will compare Arm 1 (Conversion surgery with systemic therapy (including 1L chemotherapy +/- targeted therapy +/- immunotherapy) +/- peritoneal directed chemotherapy) to Arm 2 (systemic therapy alone (including 1L chemotherapy +/- targeted therapy +/- immunotherapy) +/- peritoneal directed chemotherapy) to see if the conversion surgery will be associated with improved overall survival (OS) in Arm 1.

Participants will be randomized to either Arm 1 or Arm 2.

  • For Arm 1, participants will go for conversion surgery then continue systemic therapy.
  • For Arm 2, participants will continue systemic therapy.

Radiological assessment will be performed every 6 months or upon progression of disease, whichever comes earlier.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore
        • National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • GCPM detected on surgical exploration and demonstrated by histology or cytology
  • Primary GC not resected
  • Age > 21 (or > 18 as allowed by individual institution review boards)

Exclusion Criteria:

  • Pregnant and lactating females
  • Prior surgical treatment for GC involving resection
  • Clinical or radiological progression during 1st line systemic treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Conversion surgery with systemic therapy (including 1L chemotherapy +/- targeted therapy +/- immunot
Procedure: Conversion Surgery
Conversion surgery with systemic therapy (including 1L chemotherapy +/- targeted therapy +/- immunotherapy) +/- peritoneal directed chemotherapy
Active Comparator: systemic therapy (including 1L chemotherapy +/- targeted therapy +/- immunotherapy) +/- peritoneal d
Drug: Systemic Therapy/Standard of Care
systemic therapy (including 1L chemotherapy +/- targeted therapy +/- immunotherapy) +/- peritoneal directed chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: From enrollment to the end of follow-up at 36 months.
Time from randomization to death from any cause. Patients alive or lost to follow-up at analysis will be censored at the date last known alive.
From enrollment to the end of follow-up at 36 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: From enrollment to the end of follow-up at 36 months.
Time from randomization to radiological or clinical recurrence (Arm 1) or progression (Arm 2), or death from any cause, whichever occurs first. Patients alive and without recurrence/progression will be censored at the date last known disease-free.
From enrollment to the end of follow-up at 36 months.
Surgical outcomes
Time Frame: From surgery to 90 days post-operation, and up to the end of follow-up at 36 months for late events.
Incidence of postoperative complications graded according to the Clavien-Dindo classification.
From surgery to 90 days post-operation, and up to the end of follow-up at 36 months for late events.
Quality of Life - Global Health Status (EORTC QLQ-C30
Time Frame: Baseline and scheduled follow-up visits up to 36 months.
Change in global health status/quality-of-life score using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Scale 0-100; higher scores indicate better global health/QoL.
Baseline and scheduled follow-up visits up to 36 months.
Quality of Life - Gastro-Oesophageal Symptoms (EORTC QLQ-OG25)
Time Frame: Baseline and scheduled follow-up visits up to 36 months.
Change in symptom-specific scores using the EORTC QLQ-OG25 module assessing upper GI symptoms and treatment-related side effects. Scale 0-100; higher scores indicate worse symptoms.
Baseline and scheduled follow-up visits up to 36 months.
Quality of Life - General Health Status (EQ-5D-5L)
Time Frame: Baseline and scheduled follow-up visits up to 36 months.
Change in EQ-5D-5L health status index (range -0.594 to 1.0; higher indicates better health) and visual analog scale (VAS 0-100; higher indicates better perceived health).
Baseline and scheduled follow-up visits up to 36 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University Hospital, Singapore

Collaborators

M.D. Anderson Cancer Center
Karolinska University Hospital
Chinese University of Hong Kong
Universita di Verona
University Hospital, Montpellier
Erasmus Medical Center
Seoul National University Hospital
University of Oxford
University Hospital, Lille
Peter MacCallum Cancer Centre, Australia
Queen Mary Hospital, Hong Kong
University of Lyon
Antoni van Leeuwenhoek Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2026

Primary Completion (Estimated)

January 1, 2034

Study Completion (Estimated)

January 1, 2034

Study Registration Dates

First Submitted

October 7, 2024

First Submitted That Met QC Criteria

November 18, 2025

First Posted (Actual)

November 21, 2025

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/00052

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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