advanced gastric or gastroesophageal conjunctive adenocarcinoma
Conditions
Interventions
Experimental group:Utidelone injection
Sponsors
Affiliated Hospital of Jiangnan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1)Histology and/or cytology confirmed the diagnosis of advanced metastatic gastric or gastroesophageal conjunctive adenocarcinoma. Previous treatment after first-line standard regiments (disease progression or toxic intolerance); patients who relapsed within 6 months (less than 183 days) after adjuvant/neoadjuvant chemotherapy, if the treatment regimen was standard chemotherapy regimen, were considered as first-line treatment failure and could be included in the study. (2)At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST 1.1) (3)Male or female >=18 and = 12 weeks (6)The results of patient's laboratory biochemistry tests are as follows(had not received blood transfusions or hematopoietic-stimulating factors within 14 days): Neutrophil count (ANC) > 1.5*10^9 / L; Hemoglobin(Hb) >= 9g/dL; Platelet count (PLT) >= 80*10^9/L (7)The liver and renal function tests within 1 week before enrollment(Normal values in laboratories of each research centre are the standard): Total bilirubin=50 ml/min (8)Eligible patients (male and female) who are fertile must agree to use a reliable contraceptive method (hormonal or barrier method or abstinence) with their partner during the trial period and for at least 3 months after the last medication; women of childbearing age must have a negative blood or urine pregnancy test prior to enrollment; (9)Be able to sign informed consent.
Exclusion criteria
Exclusion criteria: (1)Received chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy and other antitumor treatments within 4 weeks prior to the first use of the study drug, except for the following: nitroso urea or mitomycin C for the first time within six weeks before inclusion; oral fluorouracil class and small molecular targeted drugs for 2 weeks before the first use of the study drug or drug within 5 half-life (in time); have antitumor indications of traditional Chinese medicine for 2 weeks before first use of the study drug. (2)Any other nonmarketed investigational drug or treatment received within 4 weeks before the first dose of the study drug (3)Had undergone major organ surgery (excluding needle biopsies) or significant trauma within 4 weeks before the first dose of the study drug or elective surgery may be required during the trial (4)Symptomatic peripheral neuropathy was evaluated by CTCAE 5.0 grade >=2 (5)Patients with severe allergy to castor oil, or who have used anti-microtubule drugs in the past and had serious adverse reactions (6)Pregnancy (positive pregnancy test) or lactation (7)The adverse effects of previous antineoplastic therapy have not recovered to CTCAE 5.0 grade =1 (except for toxicities without safety risks judged by investigators, such as alopecia) (8) patients with symptomatic central nervous system or leptomeningeal metastases or other evidence of uncontrolled central nervous system or leptomeningeal metastases, as judged by the investigator, were ineligible for enrollment. (9) patients with active infection requiring systemic anti-infection therapy. (10) a history of immunodeficiency, including positive HIV antibody test. (11) patients with a history of active hepatitis B (hepatitis B virus titer > ULN) and allowed preventive antiviral therapy except interferon; a history of hepatitis C virus infection (positive for hepatitis C antibodies). (12) A history of severe cardiovascular and cerebrovascular diseases, including but not limited: Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia, II-III degree atrioventricular block requiring clinical intervention; The mean QTcF obtained from three 12-lead ECG examinations at rest was > 470ms. Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or higher cardiovascular events occurred within 6 months before the first dose of dose. Clinically uncontrolled hypertension; Cardiac disease judged by other investigators to be at high risk; (13)patients with mental disorders or poor compliance: (14)Participants who were considered by the investigator to have a history of other serious systemic diseases or for other reasons to be ineligible for the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical benefit rate;Progression free survival;Safety; | — |
Countries
China
Contacts
Public ContactYong Mao
Affiliated Hospital of Jiangnan University
Outcome results
None listed