New drug trio takes aim at HER2-Positive stomach cancer
NCT ID NCT06730373
First seen Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time
Summary
Researchers are comparing a new combination of disitamab vedotin, sintilimab, and S-1 against the standard regimen of trastuzumab plus chemotherapy, with or without sintilimab, for people with advanced HER2-positive gastric or gastroesophageal junction cancer. The trial enrolls about 110 adults who have not received prior systemic treatment for their advanced disease. The main goal is to see how many participants' tumors shrink or disappear with each approach.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- disitamab vedotin plus sintilimab and S-1
- What this could lead to
- If the new combination works better than standard treatment, it could offer a new first-line option for people with advanced HER2-positive gastric cancer.
- What could go wrong
- This is a phase II trial with about 110 participants, so it cannot prove the combination is better than standard care. The drugs can cause nerve damage, immune reactions, and other side effects, and the results may not apply to everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 110 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Oct 2024
- Expected to finish
-
Dec 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged18-80 years, gender is not limited; 2. Pathologically confirmed locally advanced gastric or gastroesophageal junction adenocarcinoma that is inoperable or has distant metastasis; 3. HER2-Positive (IHC3+or IHC2+/FISH+) ; 4. Has at least 1 measurable lesion as determined by RECIST 1.1; 5. There is no systematic treatment in the past, or the patient has received neoadjuvant/adjuvant chemotherapy, but the disease progresses or relapses more than 6 months after the end of treatment; 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 7. Adequate organ function; 8. The life expectancy is at least 3 months; Exclusion Criteria: 1. Allergy to any trial drug and its excipients, or serious allergy history, or contraindication of the trial drug; 2. Cardiovascular and cerebrovascular events that are not well controlled; 3. Has received systematic treatment with Chinese patent medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use for ascites control) before the first administration within 2 weeks. 4. Have a history of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, acute lung disease, or systemic disease with poor control (including but not limited to diabetes, hypertension, etc.); 5. Have a history of active immune deficiency or autoimmune diseases, including HIV positive test, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation or autoimmune diseases; 6. Severe chronic or active infection requires systemic antibacterial, antifungal or antiviral treatment, including tuberculosis infection.Have a history of active tuberculosis infection ≥ 1 year before recruitment should also be excluded, unless proved has been completed appropriate treatment; 7. Brain metastasis or leptomeningeal metastasis; 8. Clinically significant pleural effusion, pericardial effusion or ascites should be drained for many times within 2 weeks before the first administration of the trial drug; 9. Has a second clinically detectable primary malignant tumor at the time of recruitment, or there were other malignant tumors in the past 5 years (except for fully treated skin basal cell carcinoma or cervical carcinoma in situ); 10. Any major surgery was performed ≤ 28 days before the first trial drug administration; 11. History of allogeneic stem cell transplantation or organ transplantation;
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for HER2-positive gastric cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
20 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Affiliated Hospital of Jining Medical College
RECRUITINGJining, Shandong, China
-
Binzhou Medical University Hospital
NOT_YET_RECRUITINGBinzhou, Shandong, China
-
Jinan Third People's Hospital
RECRUITINGJinan, Shandong, China
-
Liaocheng People's Hospital
RECRUITINGLiaocheng, Shandong, China
-
Linyi Cancer Hospital
RECRUITINGLinyi, Shandong, China
-
Qilu Hospital of Shandong University(Qingdao)
RECRUITINGQingdao, Shandong, 250063, China
-
Shandong Provincial Hospital Affiliated to Shandong First Medical University
RECRUITINGJinan, Shandong, 250012, China
-
Shandong Provincial Third Hospital
RECRUITINGJinan, Shandong, 250012, China
-
Shandong Univerisity Qilu Hospital
RECRUITINGJinan, Shandong, 250012, China
-
Shengli Oilfield Central Hospital
RECRUITINGDongying, Shandong, China
-
Taian City Central Hospital
NOT_YET_RECRUITINGTaian, Shandong, China
-
Tengzhou Central People's Hospital
RECRUITINGTengzhou, Shandong, 277599, China
-
The Affiliated Hospital of Qingdao University
NOT_YET_RECRUITINGQingdao, Shandong, China
-
The First Affiliated Hospital of Zhengzhou University
RECRUITINGZhengzhou, Henan, 450052, China
-
The Second Affiliated Hospital of Shandong First Medical University
RECRUITINGTaian, Shandong, China
-
Weifang Hospital of Traditional Chinese Medicine
NOT_YET_RECRUITINGWeifang, Shandong, China
-
Yantai Yuhuangding Hospital
RECRUITINGYantai, Shandong, China
-
Yantaishan Hospital
RECRUITINGYantai, Shandong, China
-
Zibo Central Hospital
RECRUITINGZibo, Shandong, China
-
Zibo First People's Hospital
RECRUITINGZibo, Shandong, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two-Drug combo targets HER2-Positive stomach cancer after First-Line failure
- Triple attack on HER2-Positive stomach cancer: can chemo, targeted therapy and immunotherapy shrink tumors before surgery?
- Can a Double-Pronged antibody outsmart HER2-Positive tumors?
- Can an antibody boost chemotherapy to stop early stomach cancer from returning?
- Can a targeted therapy tame hard-to-treat stomach and esophageal cancers?
- Can a targeted cancer drug deliver in the real world?