hepatocellular carcinoma
Conditions
Interventions
Group A:PM8002
Group B:Oxaplatin
Group C:Calcium folinate
Group D:fluorouracil
Total:combined treatment
Sponsors
Cancer Hospital of The University of Chinese Academy of Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntary participation in clinical study; fully understand the study and sign informed consent voluntarily; willing to follow and able to complete all test procedures; 2. Male or female aged >= 18 years; 3. HCC diagnosed by pathology or clinical; 4. BCLC stage C or B (unresectable or/and not suitable for local therapy); 5. Child-Pugh score 500 IU/mL or lower detection limit (only when the lower detection limit of the test center is higher than 500 IU/ml) but = 12 weeks; 13. Subjects shall provide tumor tissue specimens within 24 months or by biopsy for test; 14. Pre-menopausal female subjects with negative blood pregnancy results within 7 days prior to the study treatment, and agree to abstain from sex or use medically approved effective contraceptive measures for 6 months from the date of signing the informed consent form to the end of the last medication; 15. Male subjects are agree to abstain from sex or use medically approved effective contraceptive methods for 6 months from the date of signing the informed consent form to the end of the last medication, and do not donate sperm during this period.
Exclusion criteria
Exclusion criteria: 1. Histological diagnosis of fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC; 2. Imaging examination shows that the main portal vein tumor thrombus, or inferior vena cava or heart are involved; 3. Symptomatic CNS metastases, not suitable for the study assessed by investigator; 4. Evidence of major coagulopathy or other obvious risk of bleeding; 5. Patients ever received the following treatments or drugs prior to the study treatment: (1) Major surgery performed within 28 days prior to the study treatment or has a selective operation in the period of clinical trial; (2) Received liver local therapy within 14 days prior to the study treatment; (3) Received immunotherapy, nitrosourea or mitomycin C within 14 days prior to the study treatment; (4) Received non-target lesions radiotherapy within 14 days prior to the study treatment; (5) Received systemic immunostimulant therapy (such as interferon-a, interleukin-2) within 14 days prior to the study treatment or are still within 5 half-lives of the therapeutic drug (whichever is longer); (6) Received immunosuppressive drug therapy (such as corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, anti-TNF-a drugs) within 14 days prior to the study treatment; (7) Received live attenuated vaccine within 28 days prior to the study treatment; (8) Received intravenous broad-spectrum antibiotic treatment within 14 days prior to the study treatment; 6. Subjects who have previously received anti-tumor treatment must restore all treatment-related toxicity to = grade 3 peripheral sensory nerve disorder; (3) Acute coronary syndrome, coronary artery bypass grafting, congestive heart failure, aortic dissection, cerebral apoplexy or other grade 3 or above cardiovascular and cerebrovascular events; (4) QTcF interval>470 ms for female and >450 ms for male (QTcF=QT/(RR^0.33)); (5) Any factors that can increasing the risk of QTc prolonging or arrhythmia; (6) Grade 2 or above in the NYHA classification or LVEF 2.0 x ULN; (9) Using a pacemaker; 12. Patients with uncontrollable pleural, pericardial and peritoneal effusion; 13. Patients with fever (> 38.5°C) of unknown origin; 14. There are the following conditions prior to the study treatment: (1) Poorly controlled diabetes (fasting blood glucose >= 13.3 mmol/L); (2) Poorly controlled hypertension (systolic blood pressure >= 140 mmHg and/or diastolic blood pressure >= 90 mmHg); (3) History of hypertensive crisis or hypertensive encephalopathy; (4) Patients with history of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or abdominal abscess within 6 months prior to the study treatment; (5) Patients experience coarse needle biopsy or other minor surgery, excepting infusion devi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate;Incidence and severity of treatment-related adverse events; | — |
Countries
China
Contacts
Public ContactXiangdong Cheng; Jie'er Ying
Outcome results
None listed