HER2-positive Gastric Cancer, Metastatic Gastric Cancer, Unresectable Gastric Carcinoma
Conditions
Brief 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.
Interventions
DRUGDisitamab Vedotin
2.5 mg/kg IV every 3 weeks
DRUGSintilimab
200 mg IV every 3 weeks
DRUGS-1
40-60 mg BID for 14 days, every 3 weeks
DRUGTrastuzumab
First load dose is 8.0mg/kg , then 6.0 mg/kg IV every 3 weeks
DRUGOxaliplatin
130 mg/m2 Q3W
DRUGCapecitabine
1000 mg/m² Q3W
DRUG5-FU
800 mg/m²
DRUGCisplatin
80 mg/m²
Sponsors
Qilu Hospital of Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | 12 months after the last subject participating in | Progression-free survival (PFS) refers to the time from the date of randomization to the first researcher's evaluation of disease progression or death (calculated by the event that occurred first). The disease progression will be evaluated by the researchers according to the RECIST 1.1 standard. |
| Overall survival (OS) | 12 months after the last subject participating in | Overall survival (OS) refers to the time from the date of randomization to the date of death of the subject. |
| Duration of relief (DOR) | 12 months after the last subject participating in | DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death |
| Disease control rate (DCR) | 6 months after the last subject participating in | The proportion of subjects with complete response (CR) and partial response (PR) and stable disease(SD)in total subjects |
| Safety(adverse event) | Up to approximately 2 years | to evaluate safety including adverse event rate and adverse event grade. |
Countries
China
Contacts
CONTACTLian Liu, MD
CONTACTSong Li, MD
STUDY_CHAIRLian Liu, MD
Qilu Hospital of Shandong University
Outcome results
None listed