RC48 Plus AK105 and Cisplatin in Advanced Gastric Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Disitamab Vedotin Plus Penpulimab and Cisplatin in Advanced Gastric Cancer

Conditions
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Advanced Gastric Carcinoma, HER2-positive Gastric Cancer

Intervention / Treatment
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* Drug: RC48+AK105+cisplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: RC48 plus AK105 and cisplatin
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: exprimental group<br>RC48 plus AK105 and cisplatin | Drug: RC48+AK105+cisplatin<br>* RC48 plus AK105 and cisplatin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | the proportion of patients who got CR and PR | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | the duration of diseases stable or better | six months and twelve months | 
| DCR | the proportion of patients who got CR, PR and SD | three months |