Advanced Hepatosarcomatoid Carcinoma
Conditions
Interventions
Case series:Apatinib 250mg, po, qd+Gemcitabine, iv, d1, d8+Paclitaxel, iv, d1
Sponsors
First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 Years; 2. Patients with advanced hepatosarcomatoid carcinoma diagnosed by pathology and immunohistochemistry; 3. Patients who have not received chemotherapy before; 4. ECOG0-1; 5. Life expectancy of at least 12 weeks; 6. The main organs function normally, that is, the following criteria are met: (1) The blood routine examination criteria must be consistent with: (no blood transfusion and blood products within 14 days, not corrected by G-CSF and other hematopoietic stimuli): HB=90 g/L; ANC=1.5×10^9/L; PLT=80×10^9/L; (2) Biochemical tests are subject to the following criteria (ALB is not lost within 14 days): ALB=29g/L; TBIL=2ULN; ALT?AST<2.5ULN; Cr=1.5ULN; 7. Women of childbearing age must have taken reliable contraceptive measures or performed a pregnancy test (serum or urine) within 7 days prior to enrollment and the results were negative, and were willing to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the test drug. For men, consent must be given to the appropriate method of contraception or surgical sterilization during the trial and 8 weeks after the last administration of the test drug; 8. Subjects voluntarily joined the study and signed informed consent, with good adherence and follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients who have been confirmed to be allergic to apafitinib, gemcitabine and paclitaxel/or its excipients. 2. The investigator believes that patients with a clear tendency to gastrointestinal bleeding or/and patients with abnormal coagulation (INR > 1.5) and who have a tendency to hemorrhage. 3.Patients with high blood pressure who are unable to reach the normal range with antihypertensive medications. 4. Patients with other serious diseases that are difficult to control (including atrial fibrillation, angina pectoris, cardiac insufficiency, ejection fraction below 50%, liver and kidney dysfunction, urine protein detection above 2+, etc.). 5.Patients who had not undergone major surgical wounds within 4 weeks. 6. Patients who have undergone other medical treatment (including Chinese medicine) before enrollment or who cannot be guaranteed to follow the research requirements after enrollment. 7. Pregnant or lactating women. 8. Patients who are considered unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS;DOR;DCR;QoL;AEs; | — |
Countries
China
Contacts
Public ContactQin Yanru
First Affiliated Hospital of Zhengzhou University
Outcome results
None listed