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Background <p>The benefit of surgical resection in addition to systemic therapy in patients with gastric/gastroesophageal cancer and peritoneal metastases (GCPM) is controversial. This CONVERGENCE trial aims to study the potential benefits of conversion surgery in patients with peritoneal metastases.</p> Methods <p>This is a prospective, pragmatically designed, multicentre, randomized, investigator-initiated phase II/III trial. Patients with synchronous GCPM who have undergone either systemic therapy (including 1&#xa0;L chemotherapy +/- targeted therapy +/- immunotherapy) +/- peritoneal directed chemotherapy with favourable response would be randomized in 1:1 ratio to Arm 1 (Conversion surgery followed by systemic +/- peritoneal directed chemotherapy or Arm 2 (continual systemic +/- peritoneal directed chemotherapy). In the initial Phase II trial, 136 patients will be recruited and randomized. The primary endpoint is overall survival; main secondary endpoints include progression-free survival, R0 resection and complete cytoreduction rates, surgical morbidity/mortality and quality of life outcomes. If pre-defined thresholds of improved overall survival are met, the trial will expand to adequately power a phase III randomized controlled trial (<i>n</i> = 300).</p> Discussion <p>If survival benefit in conversion gastrectomy is demonstrated, this could potentially be a new standard of care for patients with peritoneal metastases from gastric or gastroesophageal junction cancer. Conversely, negative findings may lead to the avoidance of unnecessary surgical procedures and morbidity in these patients.</p> Trial registration <p>NCT07241715.</p>

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The CONVERGENCE trial protocol: a phase II/III trial for conversion surgery for gastric cancer with peritoneal metastases

  • 期刊论文

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  • 发表日期：

    2026年7月27日

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  • Daryl KA Chia,
  • Yu Chuan Tan,
  • Bee Choo Tai,
  • Xin Yi Chan,
  • Brian Badgwell,
  • Maria Bencivenga,
  • Piers Boshier,
  • Andreas Brandl,
  • Shannon Chan,
  • Delia Cortes Guiral,
  • Cuong Duong,
  • Jessie A. Elliott,
  • Clarisse Eveno,
  • Tania Fleitas Kanonnikoff,
  • Suzanne S. Gisbertz,
  • Georg Martin Haag,
  • Ken Hagiwara,
  • Mark I. van Berge Henegouwen,
  • Ignace De Hingh,
  • Hyoung-Il Kim,
  • Vo Duy Long,
  • Simon Law,
  • Hyuk-Joon Lee,
  • Misha Luyer,
  • Sheraz Markar,
  • Antoine Mariani,
  • Giovanni de Manzoni,
  • Chin-Ann Johnny Ong,
  • Beate Rau,
  • Franziska Koehler,
  • Safak Guel-Klein,
  • Sun Young Rha,
  • Johanna Van Sandick,
  • Olivia Sgabura,
  • Asim Shabbir,
  • Alberto Mitsuo Leon Takahashi,
  • Marieke Vollebergh,
  • Bas Wijnhoven,
  • Yanghee Woo,
  • Ian Yu-Hong Wong,
  • Hiroharu Yamashita,
  • Olivier Glehen,
  • Magnus Nilsson,
  • Wei Peng Yong,
  • Jimmy BY So

摘要

Background

The benefit of surgical resection in addition to systemic therapy in patients with gastric/gastroesophageal cancer and peritoneal metastases (GCPM) is controversial. This CONVERGENCE trial aims to study the potential benefits of conversion surgery in patients with peritoneal metastases.

Methods

This is a prospective, pragmatically designed, multicentre, randomized, investigator-initiated phase II/III trial. Patients with synchronous GCPM who have undergone either systemic therapy (including 1 L chemotherapy +/- targeted therapy +/- immunotherapy) +/- peritoneal directed chemotherapy with favourable response would be randomized in 1:1 ratio to Arm 1 (Conversion surgery followed by systemic +/- peritoneal directed chemotherapy or Arm 2 (continual systemic +/- peritoneal directed chemotherapy). In the initial Phase II trial, 136 patients will be recruited and randomized. The primary endpoint is overall survival; main secondary endpoints include progression-free survival, R0 resection and complete cytoreduction rates, surgical morbidity/mortality and quality of life outcomes. If pre-defined thresholds of improved overall survival are met, the trial will expand to adequately power a phase III randomized controlled trial (n = 300).

Discussion

If survival benefit in conversion gastrectomy is demonstrated, this could potentially be a new standard of care for patients with peritoneal metastases from gastric or gastroesophageal junction cancer. Conversely, negative findings may lead to the avoidance of unnecessary surgical procedures and morbidity in these patients.

Trial registration

NCT07241715.