Combination treatment for advanced HER2-positive gastric cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase II clinical trial evaluates the effectiveness of Disitamab Vedotin combined with Sintilimab and S-1 compared to Trastuzumab plus chemotherapy with or without Sintilimab for patients with HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma. The study is randomized, multicenter, and open-label, aiming to determine the best first-line treatment approach for this patient population. Participants will be monitored for measurable lesions and overall response to the treatment regimen.

Why it matters

Who can join: the full rules

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;

Where it's running

• The First Affiliated Hospital of Zhengzhou University
  Zhengzhou, Henan, China Recruiting
• Shengli Oilfield Central Hospital
  Dongying, Shandong, China Recruiting
• Shandong Provincial Hospital Affiliated to Shandong First Medical University
  Jinan, Shandong, China Recruiting
• Shandong Provincial Third Hospital
  Jinan, Shandong, China Recruiting
• Shandong Univerisity Qilu Hospital
  Jinan, Shandong, China Recruiting
• Jinan Third People's Hospital
  Jinan, Shandong, China Recruiting

Study contacts

• Study coordinator: Lian Liu, MD
• Email: tounao@126.com
• Phone: 0531-82169851

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Combination therapy of Disitamab Vedotin and Trastuzumab for HER2 positive gastric cancer

  This study is testing a new combination of two drugs, Disitamab Vedotin and Trastuzumab, to see if it can help people with advanced HER2 positive gastric cancer who haven't responded to other treatments.

  Recruiting Phase 1/2 Zhejiang Cancer Hospital · Hangzhou, Zhejiang · NCT06572319

• Fruquintinib with trastuzumab and XELOX for first-line treatment of HER2‑positive advanced stomach or GEJ cancer

  This trial will try fruquintinib together with trastuzumab and XELOX to see if it helps people with HER2‑positive advanced stomach or gastroesophageal junction cancer as their first treatment.

  Recruiting Phase 1/2 Henan Cancer Hospital · Zhengzhou, Henan · NCT07334431

• Disitamab vedotin plus trastuzumab and tislelizumab versus chemotherapy plus trastuzumab (± pembrolizumab) for HER2‑high advanced gastric or gastroesophageal junction adenocarcinoma

  This trial tests whether combining disitamab vedotin with trastuzumab and the immunotherapy tislelizumab works better than standard chemotherapy with trastuzumab (with or without pembrolizumab) as first‑line treatment for people with HER2‑high advanced gastric or gastroesophageal junction cancer.

  Recruiting Phase 3 RemeGen Co., Ltd. · Beijing, BJ-Beijing · NCT07315750

• Conversion therapy using disitamab vedotin (RC48), sintilimab, and SOX for HER2 IHC 1+ or 2+ unresectable gastric cancer

  This trial will test whether combining disitamab vedotin (RC48), the immunotherapy sintilimab, and SOX chemotherapy can shrink tumors enough to allow surgery in people with initially unresectable HER2 IHC 1+ or 2+ gastric cancer.

  Recruiting Phase 2 Fudan University · Shanghai, Shanghai Municipality · NCT07194005

• RC48 with bevacizumab or pyrotinib for HER2-positive metastatic breast cancer after T-Dxd failure

  This trial will try RC48 together with either bevacizumab or pyrotinib in adults with HER2-positive metastatic breast cancer whose disease has progressed after trastuzumab deruxtecan (T-Dxd).

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07065435

• Evaluating the effectiveness and safety of Trastuzumab Deruxtecan in advanced HER2-positive gastric cancer in China

  This study is testing how well Trastuzumab Deruxtecan works and how safe it is for people in China with advanced HER2-positive stomach cancer who are already receiving this treatment.

  Recruiting at 34 sites Daiichi Sankyo · Beijing and 39 other locations · NCT06846996

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.