Trial · NCT06846346
Testing Ivonescimab in Combination With Chemotherapy in Advanced or Metastatic Gastric/Gastroesophageal Adenocarcinoma
NCT06846346, Phase 2, Recruiting, UNICANCER
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Testing Ivonescimab in Combination With Chemotherapy in Advanced or Metastatic Gastric/Gastroesophageal Adenocarcinoma. Trials, record NCT06846346. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06846346
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Testing Ivonescimab in Combination With Chemotherapy in Advanced or Metastatic Gastric/Gastroesophageal Adenocarcinoma
- NCT number
- NCT06846346
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 88 participants, estimated
- Lead sponsor
- UNICANCER
- Conditions
- Metastatic Esophageal Adenocarcinoma, Advanced Esophageal Adenocarcinoma, Metastatic Gastric Adenocarcinoma, Advanced Gastric Adenocarcinoma
- Interventions
- Ivonescimab, FOLFOX regimen, Irinotecan, Paclitaxel
- First posted
- 2025-02-26
- Last updated
- 2026-04-28
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate assessed by central review | Time from inclusion to disease progression, up to 3 years | The objective response rate is defined as the percentage of patients with a complete response (CR) or a partial response (PR) for a given treatment |
| Secondary | Objective Response Rate assessed by the investigator | Time from inclusion to disease progression, up to 3 years | The objective response rate is defined as the percentage of patients with a complete response (CR) or a partial response (PR) for a given treatment |
| Secondary | Duration of response | Time from inclusion to disease progression or death, up to 3 years | The time form first documented response (compared to baseline measurement taken at inclusion) until the date of disease progression or death from any cause, whichever occurs first |
| Secondary | Progression-free survival (PFS) | Time from inclusion to disease progression or death, up to 3 years | The progression-free survival is the lengh of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse |
| Secondary | Overall Survival (OS) | From inclusion to death from any cause, up to 3 years | The overall survival is the length of time from inclusion that patients enrolled in the study are still alive. |
| Secondary | Time to patient performance status deterioration >2 | From inclusion to PS deterioration >2, up to 3 years | Time to performance status (PS) deterioration \>2 is defined as the time between patient inclusion and the first date when PS\>2. The Eastern Cooperative Oncology Group (ECOG) PS, a simple measure of functional status, determines ability of patient to tolerate therapies. It has scores ranging from 0 to 5 (0 = "fully active", 1 = "completely ambulatory", 2 = "\<50% in bed during the day", 3 = "\>50% in bed, but not bedbound", 4 = "bedbound", and 5 = "death"). |
| Secondary | Incidence of Treatment Adverse Events | Throughout study completion, up to 3 years | The tolerance and safety will be evaluated by toxicity (acute \[\<1 months after the end of the trial treatment\] and late \[≥1 month after the end of the trial treatment), assessed using the Common terminology criteria for adverse events version 5.0 (CTCAE v5.0). CTCAE is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders. |
| Secondary | Quality of life questionnaire - Core 30 (QLQ-C30) | At baseline, 2 months, 6 months, disease progression and first follow-up visit (up to 3 years). | Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials. The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. |
| Secondary | Quality of Life Questionnaire - Oesophago-Gastric cancer (QLQ-OG25) | At baseline, 2 months, 6 months, disease progression and first follow-up visit (up to 3 years). | This EORTC oesophago-gastric cancer specific questionnaire is intended to supplement the QLQ-C30. The QLQ-OG25 contains 25 items organized into six scales: dysphagia (three items), eating restrictions (four items), reflux (two items), odynophagia (two items), pain and discomfort (two items) and anxiety (two items), and ten single items: eating in front of others, dry mouth, trouble with taste, body image, trouble swallowing saliva, choked when swallowing, trouble with coughing, trouble talking, weight loss and hair loss. All items are rated on a four-point Likert-type scale (1 = "not at all", 2 = "a little", 3 = "quite a bit", and 4 = "very much"), and are linearly transformed to a 0-100 scale, with higher scores indicating more severe symptoms. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42669571 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06846346
GET https://conductscience.org/api/trials/v1/NCT06846346/registered