Advanced Hepatocellular Carcinoma /Gastric Cancer
Conditions
Interventions
Advanced Gastric Cancer:DX1002 table,PO,QD,600mg
Advanced Hepatocellular Carcinoma:DX1002 table,PO,QD,600mg
Sponsors
Sun Yat-Sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subject must be willing to sign an informed consent, communicate with the investigator, and follow guidance for the study; 2. Male or female, at age = 18 and = 75 years old; 3. Histologically or cytologically diagnosed with Gastric Cancer and hepatocellular carcinoma. Subjects with hepatocellular carcinoma that meet clinical diagnostic criteria from American Association for the Study of Liver Disease (AASLD) or criteria from NMPA Guidance for the Diagnosis and Treatment of Primary Liver Cancer (2022) may enroll in the study. Patients who have previously been diagnosed with hepatocellular carcinoma and the imaging (MRI/ enhanced CT/ultrasound) of new lesions has typical epatocellular carcinoma characteristics may enroll in the study as well. The subjects of the study should meet the following: • received at least first-line standard systemic therapy, including Sorafenib/Lenvatinib/Donafinib, FOLFOX chemotherapy, or combination therapy of immune checkpoint inhibitors and anti-angiogenesis, and had treatment failure (radiographic confirmation of progress) or advanced intolerant hepatocellular carcinoma diagnosed by investigators; • received at least first- and second-line systematic treatment, including platinum (cisplatin, oxaliplatin, etc.), taxol (paclitaxel, docetaxel, etc.), fluorouracils (5-FU, capecitabine, or Teysuno), and had treatment failure (progression confirmed by imaging) or advanced intolerant Gastric Cancer diagnosed by the investigator; 4. According to RECIST1.1 and/or mRECIST, the patient has at least 1 measureable lesion (in CT images, the longest the diameter of non-lymph node is =10 mm (=5-mm-thin layer CT), short axis of lymph node is =15 mm); • hepatocellular carcinoma patient should have at least 1 measurable target lesion in liver; • Gastric Cancer patient should have at least 1 measurable target lesion; 5. Child-Pugh score: A/B (=7); 6. ECOG is =1; 7. Estimated to survive for >12 weeks; 8. Must have adequate bone marrow function and organ function (no blood transfusion or treatment with hematopoietic stimulating factors within 14 days): • Absolute neutrophil count = 1.5×10?9/L (no G-SCF treatment within 1 week prior to lab test);• Hemoglobin = 90 g/L (no infusion of red blood cells within 1 week and no treatment with erythropoietin within 2 weeks prior to the lab test); • Platelet count = 100×10?9/L; if the patient have hepatocellular carcinoma, platelet count = 75×10?9/L (no infusion of platelet within 1 week and no treatment with thrombopoietin, interleukin-11, or other drugs that raise platelets count within 2 weeks prior to the lab test); • Serum creatinine =1.5× upper limit of normal (ULN) , or creatinine clearance =60 mL/min (when serum creatinine > 1.5×ULN); • Total bilirubin = 1.5×ULN; • Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) concentrations is =2.5×ULN. If AST and ALT is elevated due to liver tumor metastases, ALT and AST should be = 5× ULN. • Alkaline phosphatase = 2.5×ULS, or = 5×ULN if the investigator believes it is elevated due to liver tumor metastases. • Electrolytes: potassium = 3.0 mmol/L; serum calcium =2.0 mmol/L; • Fasting serum triglycerides = 5.7 mmol/L; • Prothrombin time (PT) = 1.5×ULN; • Partial prothrombin kinase time (APTT) = 1.5×ULN; 9. Subject must be able to orally take the investigational drug whole and intact; 10. Subject must agree to use effective contraception after signing an informed consent, during the study, and until 3 month
Exclusion criteria
Exclusion criteria: 1. Patient is at risk of bleeding. For instance, if imaging results in the screening show that the tumor wraps around important blood vessels or there is obvious necrosis or avitation, the investigator should evaluate the risk of bleeding if the subject enrolls in the study; 2. Patient has spinal cord compression or brain metastases (asymptomatic, stable condition, and those who do not require steroid therapy at least 4 weeks prior to the start of this study may be enrolled in the study); 3. Those who have a clear history of neurological or psychiatric disorders (e.g. epilepsy, dementia), or those who have suffered a stroke or cerebral hemorrhage within 6 months prior to screening; 4. Any of the following conditions occurred within 6 months prior to enrollment: significant cardiac disease such as congestive heart failure (NYHA class III or IV heart failure), myocardial infarction, unstable angina; significant ECG abnormalities, including any level of atrial fibrillation, type II second-degree atrioventricular block or third-degree AV block, or the average at rest QT interval (QTcF) from 3 ECG examinations corrected by Fridericia's formula meet the following: >450 ms in men or >470 ms in women; or other arrhythmias that require treatment; 5. Unstablized systemic diseases after treatment, such as hypertension, diabetes, thyroid disease, chronic lung, liver, kidney disease, etc,; 6. Have any active autoimmune disease or have a history of autoimmune disease; 7. Have a history of infection with human immunodeficiency virus, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation, or stem cell transplantation; 8. HBV DNA copy number >10?4 IU/mL, HCV RNA copy number > 10?3IU/mL in hepatocellular carcinoma patients, HbsAg positive and HBV-DNA =1000 IU/ml or 1000 cps/ml in gastric cancer patients, HCV antibody positive patient; or patient who is HIV or treponemal syphilis positive; 9. Patients who have a serious infection within 4 weeks prior to the first dose, or who have an active infection within 2 weeks prior to the first dose and require oral or ntravenous antibiotic therapy; 10. Failure to recover from previous chemotherapy toxicity to CTCAE grade 1 or below during screening (except for those who have special grade 2 or below toxicity that cannot be recovered in a short period of time, such as a. hair loss; b. hemoglobin level at 80 -100 g/L (including boundary values)); 11. Participants with allergies or allergic reactions to chemotherapy drugs or contrast agents for imaging; 12. Patients with CT phobia 13. Pregnant or lactating women; 14. Patients with difficulty swallowing medications orally; 15. Patient participated in clinical studies of other drugs within 4 weeks prior to the first dose of this study; 16. Patients with other conditions that the investigator believes are unsuitable for enrollment, such as a pleural effusion, pericardial effusion, or severe ascites that is accompanied by clinical symptoms or requires repeated drainage; 17. Co-infection with hepatitis B and C.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival(PFS);adverse avent(AE); | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics;Objective remission rate, ORR;Disease control rate,DCR;Median OS (mOS) in total lifetime; | — |
Countries
China
Contacts
Public ContactRuihua Xu
Sun Yat-Sen University Cancer Center
Outcome results
None listed