Immune-refractory hepatocellular carcinoma
Conditions
Interventions
Experimental group:Receive treatment with gicicitini
Sponsors
The First Affiliated Hospital of Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years and = 1.5 × 10^9 /L, cannot be achieved by using granulocyte colony-stimulating factor; (2) Platelets (PLT) >= 100 × 10^9/L, cannot be achieved by blood transfusion; (3) Hemoglobin >= 90 g/L; 2. Blood biochemical examination must meet the following requirements: (1) Serum albumin (ALB) >= 30 g/L; (2) Total bilirubin (TBil) 1.5 × UNL and indirect bilirubin 50 ml/min (Cockcroft-Gault formula as follows): Male: Cr clearance rate = ((140 - age) × weight) / (72 × blood Cr) Female: Cr clearance rate = ((140 - age) × weight) / (72 × blood Cr) × 0.85 Weight unit: kg; Blood Cr unit: mg/ml; 4. International normalized ratio (INR) <= 1.5 or prothrombin time (PT) exceeds the normal control range <= 4 seconds; 11. If the subject has HBV or HCV infection, the following conditions must be met: HBV-infected subjects (HBsAg or HBV-DNA positive): HBV-DNA < 2000 IU/ml within 28 days before the first treatment, and must continue to receive standardized antiviral treatment during the study; HCV-infected subjects (HCVAb or HCV-RNA positive): According to the investigator's judgment, in a stable state, if receiving antiviral treatment, must continue to receive treatment during the study. 12. Female subjects with reproductive capacity must undergo a serum pregnancy test 7 days before the first administration and the result must be negative, and not be in the lactation period. Must agree to use effective contraceptive measures during the study and within 6 months after the last administration of the drug; For male subjects whose partner is a fertile female, surgical sterilization or must agree to use effective contraceptive measures during the study and within 3 months after the last administration of the drug. During the study, sperm donation is not allowed. 13. The subject has good compliance and cooperates with follow-up.
Exclusion criteria
Exclusion criteria: 1.The known pathological type was cholangiocarcinoma or cholangio-hepatocellular carcinoma mixed type. 5 years or concurrent malignant tumors other than hepatocellular carcinoma. Localized tumors that had been cured, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, and carcinoma in situ of the breast, could be enrolled. 2.Patients with a history of hepatic encephalopathy. 3.Patients with obstructive jaundice (after active treatment such as biliary drainage or stent placement and liver function recovery) could be enrolled. 4.Patients who were preparing for or had previously received organ or allogeneic bone marrow transplantation. 5.Moderate or severe ascites with clinical symptoms, which required therapeutic puncture or drainage, or ascites score >2 in the Child-Pugh score (except those with only a small amount of ascites on imaging but no clinical symptoms); Uncontrolled pleural effusion, pericardial effusion. 6.A history of gastrointestinal bleeding within 6 months before the initiation of study treatment or a definite tendency to gastrointestinal bleeding, such as: Patients with esophagogastric varices at risk for bleeding, local active peptic ulcer lesions, or persistent positive fecal occult blood were excluded (patients with positive fecal occult blood at baseline required repeat testing, and patients with positive fecal occult blood after repeat testing required gastroscopy. Patients with esophagogastric varices at risk for bleeding on gastroscopy were excluded). 7.Known inherited or acquired bleeding (such as coagulopathy) or thrombophilia, as in patients with hemophilia; Current or recent (within 10 days before the initiation of study treatment) use of full-dose oral or injectable anticoagulant or thrombolytic agents for therapeutic purposes (prophylactic use of low-dose aspirin and low-molecular-weight heparin was allowed). 8.Thrombotic or embolic events, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc., occurred within 6 months before the initiation of study treatment. 9.Clinical symptoms or diseases of the heart that are not well controlled, such as: (1) grade II or higher cardiac dysfunction according to the New York Heart Association (NYHA) criteria (see Appendix) or cardiac color Doppler ultrasound examination: Left ventricular ejection fraction (LVEF) 450ms (men); QT >470ms (in women). (QTc intervals were calculated with the use of Fridericia's formula; if QTc was abnormal, three consecutive measurements were performed at 2-minute intervals and averaged.); 10.A history of intestinal obstruction and/or clinical signs or symptoms of gastrointestinal obstruction within 6 months before starting study treatment, including incomplete obstruction related to preexisting disease or requiring routine parenteral hydration, parenteral nutrition, or tube feeding. 11.Previous and current history of pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), and interstitial disease Patients with pneumonitis, pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or evidence of active pneumonia on chest
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;Progression-free survival;Time to remission; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival(OS);Safety and tolerability;During of response;Disease control rate;Quality of life(QoL); | — |
Countries
China
Contacts
Public ContactZhiyu Chen
The First Affiliated Hospital of the Army Medical University of the People's Liberation Army of China
Outcome results
None listed