Phase
Condition
Digestive System Neoplasms
Gastric Cancer
Stomach Cancer
Treatment
N/AClinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Voluntary participation in the clinical study; fully understands and is informed ofthe study and has signed the Informed Consent Form (ICF); willing to comply with andable to complete all trial procedures.
- The gender is not limited. When ICF is signed, the age is ≥ 18 years and ≤ 70 yearsold.
- Histologically confirmed untreated gastric cancers, mainly adenocarcinoma.
- Within 4 weeks prior to first dose, determined by the Independent Radiology ReviewCommittee (IRRC) as: ≥ T3 and number of lymph node metastases ≥ 1 and no distantmetastasis.
- Prior to enrollment, the attending physician will evaluate to determine theeligibility for a R0 resection for the purpose of radical treatment.
- Have good cardiac function and can be treated with radical resection.
- tumor specimen testing results are PD-L1 positive (CPS ≥5). Subjects must provide thetumor tissues at screening or in the investigated surgery (if any), for PD-L1expression level assessment.
- Within 7 days before the first use of the study drug, ECOG: 0 ~ 1;
- Expected survival 12 weeks;
- The functions of the vital organs meet requirements.
Exclusion
Exclusion Criteria:
- Existence of other active malignant tumors within 5 years or at the same time.
- Plan to perform or have undergone an organ or bone marrow transplant.
- Myocardial infarction and poorly controlled arrhythmias occurred within 6 months priorto the first dose.
- Existence of grade III - IV cardiac disorders defined by the NYHA or echocardiogramshows: LVEF (left ventricular ejection fraction) < 50%.
- Human immunodeficiency virus (HIV) infection.
- Patients with active tuberculosis.
- Patient with previous or current interstitial pneumonia, pneumoconiosis, radiationpneumonitis, drug-associated pneumonia, severely impaired lung function, etc.
- Patients who have previously received other antibody/drug treatments for immunecheckpoints, such as PD-1, PD-L1, and CTLA4 treatments.
- Have diseases that may increase the risk of participating in the study and using thestudy medications, or other severe, acute, and chronic diseases and therefore arejudged by the investigator to be unsuitable for clinical studies.
Study Design
Connect with a study center
Peking University shenzhen hospital
Shenzhen, Guangdong
ChinaActive - Recruiting
Affiliated Hospital of Hebei University
Baoding,
ChinaActive - Recruiting
Beijing Cancer Hospital
Beijing,
ChinaActive - Recruiting
China PLA General Hospital
Beijing,
ChinaActive - Recruiting
Peking University International Hospital
Beijing,
ChinaActive - Recruiting
Peking University Third Hospital
Beijing,
ChinaActive - Recruiting
The First Affiliated Hospital of Bengbu Medical College
Bengbu,
ChinaActive - Recruiting
Cangzhou People's Hospital
Cangzhou,
ChinaActive - Recruiting
Anhui Provincial Hospital
Hefei,
ChinaActive - Recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei,
ChinaActive - Recruiting
Linyi Cancer Hospital
Linyi,
ChinaActive - Recruiting
The Fourth Hospital of Hebei Medical University
Shijia Zhuang,
ChinaActive - Recruiting
Shanxi Provincial People's Hospital
Taiyuan,
ChinaActive - Recruiting
Tianjin Medical University Institute & Hospital
Tianjin,
ChinaActive - Recruiting
Xingtai People's Hospital
Xingtai,
ChinaActive - Recruiting

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