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NCT Number: NCT07241715

Conversion Surgery for Gastric Cancer With Peritoneal Metastases (CONVERGENCE)

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Gastric Cancer Stage IV Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Peritoneal Metastasis Stomach Diseases Stomach Neoplasms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

National University Hospital

Singapore

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conversion Surgery

Procedure

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

Systemic Therapy/Standard of Care

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

Sponsors and collaborators

Lead sponsor

National University Hospital, Singapore

Other

Collaborators

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

Registry information

Acronym: CONVERGENCE

Important dates

Study start
2026
Primary completion
2034
Study completion
2034
First posted
Nov 21, 2025
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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