Advanced Gastric Carcinoma, HER2-positive Gastric Cancer
Conditions
Brief summary
To explore the safety and clinical efficacy of cisplatin combined with RC48 and anti-PD-1 antibodies AK105 in Her-2 positive advanced gastric cancer.
Detailed description
Although anti-PD-1 antibody could prolong the survival of patients with adanced gastic cancer, there are relatively few reports on anti-PD-1 antibody therapy in Her2-positive gastric cancer. RC48 is a primary anti-HER2 antibody-drug conjugate, which has been approved by the Chinese NMPA for the later-line treatment of Her2-positive gastric cancer. This study was to explore the safety and clinical efficacy of RC48 combined with cisplatin and AK105 in previously untreated patients with HER2-positive gastric cancer.
Interventions
DRUGRC48+AK105+cisplatin
RC48 plus AK105 and cisplatin
Sponsors
Rongchang Biopharmaceutical
Zhengda Tianqing Pharmaceutical Group Co., Ltd.
Henan Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
RC48 plus AK105 and cisplatin
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years old, ≤75 years old, regardless gender * Pathologically confirmed gastric adenocarcinoma, Her2 immunohistochemical examination of 2+ or 3+ * ECOG PS scores 0-1 * Stage IV according to AJCC 8.0 and no systemic therapy previously * Expected lifespan ≥ 3 months * Adequate organ function * At least one measurable lesion according to RECIST 1.1 * Asymptomatic intracranial metastasis * No history of other malignancies * Women of childbearing age must have a negative blood pregnancy test within 7 days, and subjects of childbearing age must use appropriate contraception during the trial and for 6 months after the trial * Agreed to participate in this clinical study and signed the Informed Consent
Exclusion criteria
* Currently participating in an interventional clinical investigational treatment, or have received other investigational drugs or treatment with an investigational device within 4 weeks prior to the first dose * Received anti-PD-1, anti-PD-L1, anti-CTLA-4, and other checkpoint inhibitor * Received traditional Chinese medicines or immunomodulatory drugs with anti-gastric cancer indications within 2 weeks before the first administration * Active autoimmune diseases or immunodeficiency diseases * Allergy to any test drug and its excipients, or a history of severe allergy, or contraindication to the test drug * Severe mental disorder * Receiving systemic corticosteroids within 7 days prior to the first dose of the study * Clinically apparent cardiovascular and cerebrovascular disease * Others investigators evaluated not meet the inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | three months | the proportion of patients who got CR and PR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS | six months and twelve months | the duration of diseases stable or better |
| DCR | three months | the proportion of patients who got CR, PR and SD |
Countries
China
Contacts
Primary ContactQuanli Gao, Dr
Outcome results
None listed