KCT0004253
Not yet recruiting
未知
Phase II Study of Neoadjuvant Immune Checkpoint Inhibitor in Patients with Resectable Gastrointestinal Cancers
ConditionsNeoplasms
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Neoplasms
- Sponsor
- Asan Medical Center
- Enrollment
- 48
- Status
- Not yet recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •To be eligible for this study, subjects must meet all of the following criteria:
- •Disease\-related inclusion criteria
- •1\)Histologically confirmed localized gastric adenocarcinoma, esophageal squamous cell carcinoma, hepatocellular carcinoma or clinically diagnosed hepatocellular carcinoma according to American Association for the Study of Liver Disease (AASLD) guidelines.
- •2\)Curatively resectable gastric adenocarcinoma, esophageal squamous cell carcinoma or hepatocellular carcinoma
- •Gastric adenocarcinoma: clinical stage \=T2 or regional lymph node metastasis (N\+) (AJCC 8th)
- •Esophageal squamous cell carcinoma: clinical stage \=T1b or N\+ (AJCC 8th)
- •Hepatocellular carcinoma: a single hepatocellular carcinoma limited to liver or 3 or less hepatocellular carcinoma limited to liver without invasion to main portal trunk
- •3\)The requirements for hematology, blood chemistry, and functionality in major organs are as follows (should be met within 7 days prior to the first administration of investigational medicinal product):
- •Absolute neutrophil count \=1,000/µL
- •Platelets count \=75,000/µL
Exclusion Criteria
- •If any of the following criteria is met, subjects will be excluded.
- •Tumor\-related exclusion criteria
- •1\)Curatively unresectable or metastatic disease
- •2\)Any prior treatment for gastric adenocarcinoma, esophageal squamous cell carcinoma or hepatocellular carcinoma. However, in case of hepatocellular carcinoma, it is possible for subjects to be enrolled into the study only if the treatment for local lesion was carried out \=6 months ago and the treated area showed disease progression, or a curatively resectable new lesion has occurred outside the previously treated area, and other inclusion/exclusion criteria are met.
- •3\)Patients with history of other cancers within three years prior to the study treatment. However, patients with other cancers with less influence on their prognosis such as carcinoma in situ or thyroid papillary carcinoma, in the opinion of the investigator, can be enrolled into the study.
- •4\)History of hepatic encephalopathy.
- •5\)Clinically significant ascites defined as follows:
- •When screening, the physical examination reveals ascites or
- •Previous ascites that required treatment and continuous prevention or current ascites that require treatment.
- •Investigational medicinal product\-related exclusion criteria
Outcomes
Primary Outcomes
Not specified
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