Conversion Surgery for Gastric Cancer With Peritoneal Metastases (CONVERGENCE)

Summary

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.

Conditions

• Gastric Cancer Stage IV
• Peritoneal Metastasis

Interventions

PROCEDURE

Conversion Surgery

Conversion surgery with systemic therapy (including 1L chemotherapy +/- targeted therapy +/- immunotherapy) +/- peritoneal directed chemotherapy

DRUG

Systemic Therapy/Standard of Care

systemic therapy (including 1L chemotherapy +/- targeted therapy +/- immunotherapy) +/- peritoneal directed chemotherapy

Sponsors & Collaborators

• Karolinska University Hospital

  collaborator OTHER

• University of Lyon

  collaborator OTHER

• M.D. Anderson Cancer Center

  collaborator OTHER

• Seoul National University Hospital

  collaborator OTHER

• University of Oxford

  collaborator OTHER

• Peter MacCallum Cancer Centre, Australia

  collaborator OTHER

• Queen Mary Hospital, Hong Kong

  collaborator OTHER

• Chinese University of Hong Kong

  collaborator OTHER

• University Hospital, Lille

  collaborator OTHER

• Erasmus Medical Center

  collaborator OTHER

• University Hospital, Montpellier

  collaborator OTHER

• Universita di Verona

  collaborator OTHER

• Antoni van Leeuwenhoek Hospital

  collaborator OTHER

• National University Hospital, Singapore

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-02-21

Primary Completion

2034-01-31

Completion

2034-01-31

Countries

• Singapore

Study Locations