Advanced Solid Tumor
Conditions
Interventions
Experimental group:ZL-85FA Tablets Intervention Therapy
Sponsors
The First Affiliated Hospital Of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary participation in this study, signing the informed consent form, good compliance, and able to cooperate with follow-up; 2. Age: >= 18 years old and = 12 weeks; 7. Adequate organ function; 8. All acute toxic reactions from previous anti-cancer treatment or surgical procedures have been relieved to the baseline severity or NCI-CTCAE version 5.0 <= 1 grade (excluding hair loss or other toxicities considered safe by the investigator that do not pose a risk to the patient); 9. Married women and men should agree to take effective contraceptive measures during the study period and within 6 months after the study ends (hormonal or barrier methods or abstinence); for married female patients, the serum or urine pregnancy test should be negative within 7 days before administration, and must be non-lactating patients.
Exclusion criteria
Exclusion criteria: 1. Known severe allergy to the investigational drug or any of its excipients (lactose, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, caprylic glycerol ester, hydroxypropyl methylcellulose, film-coated pre-mix (gastric-release type)), except for skin basal cell carcinoma or squamous cell carcinoma that has been fully treated, and cervical carcinoma in situ, provided that radical treatment has been performed and there is no recurrence or metastasis within the past 5 years; 2. Currently or previously have other malignant tumors (except for skin basal cell carcinoma or squamous cell carcinoma that has been fully treated), unless radical treatment has been performed and there is no recurrence or metastasis within the past 5 years; 3. Symptomatic central nervous system (CNS) metastasis or requiring steroid treatment within 2 weeks before the first use of the investigational drug, and asymptomatic CNS metastasis. Patients with carcinomatous meningitis or soft meningeal spread; 4. Within 4 weeks before the first administration, received the last systemic anti-tumor treatment (chemotherapy, targeted therapy, immunotherapy, biological agent therapy, etc.), mitomycin or nitrosamine within 6 weeks, small molecule targeted drugs within 2 weeks before the first administration of the investigational drug or within 5 half-lives of the known drug (whichever is longer), local palliative radiotherapy within 2 weeks before the first use of the investigational drug; endocrine therapy last administration within 2 weeks before the first administration of the investigational drug (except for necessary drug castration therapy for metastatic castration-resistant prostate cancer patients); the first administration of the investigational drug within 2 weeks before the patient received traditional Chinese medicine or Chinese patent medicine with anti-tumor indications; 5. Within 4 weeks before the first administration had a severe infection, or had active infection requiring oral or intravenous antibiotic treatment within 2 weeks before the first administration; patients with active pulmonary tuberculosis, those who have undergone adequate treatment and have stopped anti-tuberculosis treatment for >= 3 months before the first administration can be enrolled; 6. Within 2 weeks before the first use of the investigational drug received treatment such as blood transfusion, recombinant human thrombopoietin, recombinant human interleukin-11, erythropoietin, granulocyte colony-stimulating factor, etc.; 7. Within 14 days before the first administration received systemic corticosteroids (prednisone > 10 mg/day or equivalent doses of similar drugs, continuous use for more than 4 days) or other immunosuppressant treatments; except for the following situations: treatment with local, ocular, joint cavity, nasal and inhalation corticosteroids, short-term use of corticosteroids for preventive treatment, such as the use of contrast agents. 8. Uncontrolled or significant cardiovascular and cerebrovascular diseases, including: (1) Within 6 months before the first administration, developed NYHA grade II or above congestive heart failure, unstable angina pectoris, myocardial infarction, or had a need for treatment of arrhythmia at the screening, or left ventricular ejection fraction (LVEF) < 50%; (2) Primary cardiomyopathy (such as dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, und
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Time to response;Duration of response;Progression free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactSun Beicheng/Zhou Huan
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed