Conversion Surgery for Gastric Cancer With Peritoneal Metastases (CONVERGENCE)

NCT ID: NCT07241715

Last Updated: 2025-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2034-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gastric Cancer Stage IV Peritoneal Metastasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Conversion surgery with systemic therapy (including 1L chemotherapy +/- targeted therapy +/- immunot

Group Type EXPERIMENTAL

Conversion Surgery

Intervention Type PROCEDURE

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

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

Group Type ACTIVE_COMPARATOR

Systemic Therapy/Standard of Care

Intervention Type DRUG

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

Interventions

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Conversion Surgery

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

Intervention Type PROCEDURE

Systemic Therapy/Standard of Care

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska University Hospital

OTHER

Sponsor Role collaborator

University of Lyon

OTHER

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role collaborator

Peter MacCallum Cancer Centre, Australia

OTHER

Sponsor Role collaborator

Queen Mary Hospital, Hong Kong

OTHER

Sponsor Role collaborator

Chinese University of Hong Kong

OTHER

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role collaborator

Erasmus Medical Center

OTHER

Sponsor Role collaborator

University Hospital, Montpellier

OTHER

Sponsor Role collaborator

Universita di Verona

OTHER

Sponsor Role collaborator

National University Hospital, Singapore

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Professor Jimmy So

Role: CONTACT

+65 6908 2222

Other Identifiers

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2024/00052

Identifier Type: -

Identifier Source: org_study_id

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