Gastric Cancer Stage IVPhase 2/3CONVERGENCENCT07241715
Conversion Surgery for Gastric Cancer With Peritoneal Metastases (CONVERGENCE)
A Phase 2/3 study testing Conversion Surgery in people with Gastric Cancer Stage IV and Peritoneal Metastasis, run by National University Hospital, Singapore at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Gastric Cancer Stage IV, Peritoneal Metastasis
- What is being tested?
- Conversion Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSingapore
- Study dates
- 21 Feb 2026to Jan 2034
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Pregnant and lactating females
- Prior surgical treatment for GC involving resection
- Clinical or radiological progression during 1st line systemic treatment
Trial locations and contacts
1 site in 1 country.
About this study
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?
Read more
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
- Being tested
- Conversion Surgery, Systemic Therapy/Standard of Care
- Keywords
- Gastric cancer, Peritoneal Metastasis
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conversion SurgeryProcedure or surgery
Conversion surgery with systemic therapy (including 1L chemotherapy +/- targeted therapy +/- immunotherapy) +/- peritoneal directed chemotherapy
Systemic Therapy/Standard of CareDrug
systemic therapy (including 1L chemotherapy +/- targeted therapy +/- immunotherapy) +/- peritoneal directed chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Conversion surgery with systemic therapy (including 1L chemotherapy +/- targeted therapy +/- immunot | Experimental | Not described Receives: Procedure: Conversion Surgery |
| systemic therapy (including 1L chemotherapy +/- targeted therapy +/- immunotherapy) +/- peritoneal d | Active comparator | Not described Receives: Drug: Systemic Therapy/Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
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.
Measured: From enrollment to the end of follow-up at 36 months.
Secondary outcomes (5)
Progression-free survival (PFS)
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.
Measured: From enrollment to the end of follow-up at 36 months.
Surgical outcomes
Incidence of postoperative complications graded according to the Clavien-Dindo classification.
Measured: 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
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.
Measured: Baseline and scheduled follow-up visits up to 36 months.
Quality of Life - Gastro-Oesophageal Symptoms (EORTC QLQ-OG25)
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.
Measured: Baseline and scheduled follow-up visits up to 36 months.
Quality of Life - General Health Status (EQ-5D-5L)
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).
Measured: Baseline and scheduled follow-up visits up to 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start21 Feb 2026
- Primary completionJan 2034 (estimated)
- Study completionJan 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric Cancer Stage IVStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital, University of Lyon, M.D. Anderson Cancer Center, Seoul National University Hospital, University of Oxford, Peter MacCallum Cancer Centre, Australia, Queen Mary Hospital, Hong Kong, Chinese University of Hong Kong, University Hospital, Lille, Erasmus Medical Center, University Hospital, Montpellier, Universita di Verona, Antoni van Leeuwenhoek Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07241715
- Sponsor's protocol ID
- 2024/00052
- Acronym
- CONVERGENCE
- Status last verified
- Oct 2025
- First submitted
- 7 Oct 2024
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chia DK, Tan YC, Tai BC, Chan XY, Badgwell B, Bencivenga M, Boshier P, Brandl A, Chan S, Guiral DC, Duong C, Elliott JA, Eveno C, Kanonnikoff TF, Gisbertz SS, Haag GM, Hagiwara K, van Berge Henegouwen MI, De Hingh I, Kim HI, Long VD, Law S, Lee HJ, Luyer M, Markar S, Mariani A, de Manzoni G, Ong CJ, Rau B, Koehler F, Guel-Klein S, Rha SY, Van Sandick J, Sgabura O, Shabbir A, Takahashi AML, Vollebergh M, Wijnhoven B, Woo Y, Wong IY, Yamashita H, Glehen O, Nilsson M, Yong WP, So JB. The CONVERGENCE trial protocol: a phase II/III trial for conversion surgery for gastric cancer with peritoneal metastases. BMC Cancer. 2026 Jul 27;26(1):1276. doi: 10.1186/s12885-026-16423-2.
PubMed 42919242
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conversion Surgery for Gastric Cancer With Peritoneal Metastases (CONVERGENCE)
- ClinicalTrials.gov ID
- NCT07241715
- Acronym / sponsor ID
- CONVERGENCE / 2024/00052
- Conditions
- Gastric Cancer Stage IV, Peritoneal Metastasis
- Keywords
- Gastric cancer, Peritoneal Metastasis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- Karolinska University Hospital, University of Lyon, M.D. Anderson Cancer Center, Seoul National University Hospital, University of Oxford, Peter MacCallum Cancer Centre, Australia, Queen Mary Hospital, Hong Kong, Chinese University of Hong Kong, University Hospital, Lille, Erasmus Medical Center, University Hospital, Montpellier, Universita di Verona, Antoni van Leeuwenhoek Hospital
- Study start
- 21 Feb 2026 (actual)
- Primary completion
- Jan 2034 (estimated)
- Study completion
- Jan 2034 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conversion surgery with systemic therapy (including 1L chemotherapy +/- targeted therapy +/- immunot | Experimental | Procedure: Conversion Surgery |
| systemic therapy (including 1L chemotherapy +/- targeted therapy +/- immunotherapy) +/- peritoneal d | Active comparator | Drug: Systemic Therapy/Standard of Care |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- Pregnant and lactating females
- Prior surgical treatment for GC involving resection
- Clinical or radiological progression during 1st line systemic treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conversion SurgeryConversion surgery with systemic therapy (including 1L chemotherapy +/- targeted therapy +/- immunotherapy) +/- peritoneal directed chemotherapy | Procedure or surgery | Conversion surgery with systemic therapy (including 1L chemotherapy +/- targeted therapy +/- immunot |
| Systemic Therapy/Standard of Caresystemic therapy (including 1L chemotherapy +/- targeted therapy +/- immunotherapy) +/- peritoneal directed chemotherapy | Drug | systemic therapy (including 1L chemotherapy +/- targeted therapy +/- immunotherapy) +/- peritoneal d |
Primary outcome
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.
5 secondary outcomes
Progression-free survival (PFS)
Time frame: 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.
Quality of Life - Global Health Status (EORTC QLQ-C30
Time frame: 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.
Quality of Life - General Health Status (EQ-5D-5L)
Time frame: Baseline and scheduled follow-up visits up to 36 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Derived from this study: PubMed 42919242Chia DK, Tan YC, Tai BC, Chan XY, Badgwell B, Bencivenga M, Boshier P, Brandl A, Chan S, Guiral DC, Duong C, Elliott JA, Eveno C, Kanonnikoff TF, Gisbertz SS, Haag GM, Hagiwara K, van Berge Henegouwen MI, De Hingh I, Kim HI, Long VD, Law S, Lee HJ, Luyer M, Markar S, Mariani A, de Manzoni G, Ong CJ, Rau B, Koehler F, Guel-Klein S, Rha SY, Van Sandick J, Sgabura O, Shabbir A, Takahashi AML, Vollebergh M, Wijnhoven B, Woo Y, Wong IY, Yamashita H, Glehen O, Nilsson M, Yong WP, So JB. The CONVERGENCE trial protocol: a phase II/III trial for conversion surgery for gastric cancer with peritoneal metastases. BMC Cancer. 2026 Jul 27;26(1):1276. doi: 10.1186/s12885-026-16423-2.
- Individual participant dataSharing planned: Undecided
Related trials for Gastric Cancer Stage IV
RecruitingPhase 1
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Solid Tumor, Advanced Solid Tumor
Active, not recruitingPhase 2
Ramucirumab and Trifluridine/Tipiracil or Paclitaxel for the Treatment of Patients With Previously Treated Advanced Gastric or Gastroesophageal Junction Cancer
Clinical Stage III Gastric Cancer AJCC v8, Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
Active, not recruitingPhase 2
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingPhase 1/2
Lenvatinib in Combination With Nivolumab Plus Chemotherapy in Metastatic Gastric Cancer Patients With Malignant Ascites
STOMACH NEOPLASM, Gastric Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Conversion Surgery in people with Gastric Cancer Stage IV and Peritoneal Metastasis, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: From enrollment to the end of follow-up at 36 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07241715, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.