ITMCTR2200005508
Recruiting
Phase 1
Clinical study of the traditional Chinese medicine wenyangtongluo formula combined with toripalimab plus apatinib and tegio as the third line for advanced gastric cancer
Department of Oncology of Integrated Traditional Chinese and Western Medicine, High-tech Campus, First Affiliated Hospital of Anhui0 sitesTBD
ConditionsStomach cancer
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Stomach cancer
- Sponsor
- Department of Oncology of Integrated Traditional Chinese and Western Medicine, High-tech Campus, First Affiliated Hospital of Anhui
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(1\) According to the 8th edition of the TNM staging of gastric cancer by the International Association for Gastric Cancer Research and the Joint Committee on Cancer Classification of the United States, patients with histopathological or cytological diagnosis of advanced gastric cancer stage IV;
- •(2\) Between 18 and 75 years old;
- •(3\) Third\-line treatment patients who have received two chemotherapy regimens after treatment failure, according to the RECIST 1\.1 standard proved that the first and second\-line treatment failed or were intolerable;
- •(4\) The KPS score is greater than 60 points; the expected survival period is more than 3 months;
- •(5\) No obvious signs of blood system disease, no bleeding tendency; no serious liver and kidney damage;
- •(6\) Complete the imaging examination within 2 weeks before the selected trial as the basic data;
- •(7\) The patient is informed, has good compliance, and has signed an informed consent.
Exclusion Criteria
- •(1\) Does not meet the inclusion criteria;
- •(2\) Pregnant or lactating women;
- •(3\) TCM syndrome differentiation is for patients with non\-Yang deficiency and toxin stagnation syndrome;
- •(4\) Patients with severe liver, kidney and hematopoietic system dysfunction, and mental illness;
- •(5\) Accompanied by other malignant or uncontrollable diseases, defined as follows:
- •· Suffered from myocardial infarction, unstable angina or congestive heart failure 6 months before entering the study;
- •· There is an unstable arrhythmia that requires clinical treatment;
- •· There are infections that are difficult to control;
- •·Chronic obstructive pulmonary disease worsens or there are other respiratory diseases that require hospitalization;
- •· Diabetes is poorly controlled (fasting blood glucose (FBG)\> 10mmol/L);
Outcomes
Primary Outcomes
Not specified
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