Status:
UNKNOWN
RC48 Plus AK105 and Cisplatin in Advanced Gastric Cancer
Lead Sponsor:
Henan Cancer Hospital
Collaborating Sponsors:
Rongchang Biopharmaceutical
Zhengda Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Advanced Gastric Carcinoma
HER2-positive Gastric Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05313906
Start Date
May 7 2022
End Date
April 30 2024
Last Update
April 6 2022
Active Locations (1)
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1
Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
Zhengzhou, Henan, China, 450008