Trastuzumab: First load dose is 8.0mg/kg , then 6.0 mg/kg IV every 3 weeks
Oxaliplatin: 130 mg/m2 Q3W
Capecitabine: 1000 mg/m² Q3W
5-FU: 800 mg/m²
Cisplatin: 80 mg/m²
Study summary
This is a Phase II, randomized, multicenter, open-label clinical trial designed to compare Disitamab Vedotin plus Sintilimab and S-1 with Trastuzumab plus chemotherapy ± Sintilimab for first-line treatment of HER2-Positive advanced gastric or gastroesophageal junction adenocarcinoma.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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;
Primary outcome measure(s)
Objective remission rate (ORR) — 6 months after the last subject participating in The proportion of subjects with complete response (CR) and partial response (PR) in total subjects
Trial sites (20)
Facility
City
Region
Status
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
Henan
Recruiting
Binzhou Medical University Hospital
Binzhou
Shandong
Not Yet Recruiting
Shengli Oilfield Central Hospital
Dongying
Shandong
Recruiting
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan
Shandong
Recruiting
Shandong Provincial Third Hospital
Jinan
Shandong
Recruiting
Shandong Univerisity Qilu Hospital
Jinan
Shandong
Recruiting
Jinan Third People's Hospital
Jinan
Shandong
Recruiting
Affiliated Hospital of Jining Medical College
Jining
Shandong
Recruiting
Liaocheng People's Hospital
Liaocheng
Shandong
Recruiting
Linyi Cancer Hospital
Linyi
Shandong
Recruiting
Qilu Hospital of Shandong University(Qingdao)
Qingdao
Shandong
Recruiting
The Affiliated Hospital of Qingdao University
Qingdao
Shandong
Not Yet Recruiting
Taian City Central Hospital
Taian
Shandong
Not Yet Recruiting
The Second Affiliated Hospital of Shandong First Medical University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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