hepatocellular carcinoma
Conditions
Interventions
Patients with unresectable hepatocellular carcinoma eligible at first diagnosis:None
Sponsors
The Third Affiliated Hospital of Naval Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in this study and sign the informed consent form; 2. Age >=18 years old, male or female; 3. Patients with intermediate and advanced unresectable hepatocellular carcinoma; 4. Have not received anti-tumor therapy (such as surgery, radiotherapy, TACE, ablation, chemotherapy, targeted therapy, immunotherapy, etc.); 5. Child-Pugh Liver Function Rating: Grade A-B (= 12 weeks; 8. Laboratory test values meet the following requirements: (1) Routine blood tests: (except hemoglobin, not transfused, not using granulocyte colony-stimulating factor [G-CSF], and not corrected with medications in the 2 weeks prior to screening): absolute neutrophil count >= 1.5 × 10^9/L; platelets >= 80 × 10^9/L; hemoglobin >= 90 g/L; (2) Biochemical tests: serum albumin >=30 g/L; serum total bilirubin 50 ml/min (Cockcroft-Gault formula is as follows): male: Cr clearance = ((140 - age) × body weight)/(72 × blood Cr) female Cr clearance = ((140 - age) × body weight) / (72 × blood Cr) × 0.85 Body weight unit: kg; blood Cr unit: mg/ml; (3) International normalized ratio (INR) =2+, 24-hour (h) urine protein quantification can be performed, and 24-h urine protein quantification =12 consecutive months, with no reason other than menopause), and has not undergone sterilization (e.g., hysterectomy, bilateral tubal ligation, or bilateral salpingo-oophorectomy); 11. For male subjects whose partner is a female of childbearing potential, they must agree to abstain from sexual intercourse or use a reliable, effective method of contraception from the time of signing the Informed Consent Form until at least 120 days after the last dose of study drug. Male subjects must also agree not to donate sperm during the same time period. Male subjects whose partners are pregnant must use condoms and no other method of contraception.
Exclusion criteria
Exclusion criteria: 1. Known pathology of intrahepatic cholangiocellular carcinoma, sarcomatoid HCC, mixed cell carcinoma, and fibrous platysmal cell carcinoma; active malignancy other than HCC within 5 years or concurrently. Cured limited tumors, such as basal cell carcinoma of the skin, squamous carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, carcinoma in situ of the breast, etc. can be enrolled; 2. Current concomitant interstitial pneumonitis or interstitial lung disease, or previous history of interstitial pneumonitis or interstitial lung disease requiring hormonal therapy, or other pulmonary fibrosis that may interfere with the determination and management of immune-related pulmonary toxicity, mechanized pneumonitis (e.g., occlusive bronchiectasis), pneumoconiosis, drug-associated pneumonitis, idiopathic pneumonitis, or active pneumonitis as seen on the screening chest computed tomography (CT) picture Subjects with evidence or severely impaired lung function are allowed to have a history of radiation pneumonitis in the radiation field: active tuberculosis; 3. Presence of active autoimmune disease or history of autoimmune disease with potential for relapse (including, but not limited to: autoimmune hepatitis, interstitial pneumonitis, uveitis, enterocolitis, pituitary gland inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism [subjects who are manageable with hormone replacement therapy only are eligible for enrollment]): subjects with dermatological disorders that do not require systemic treatment such as auto-epilepsy, psoriasis alopecia areata, controlled type I diabetes mellitus treated with insulin or asthma that has completely resolved in childhood and does not require any intervention in adulthood may be included: asthmatics requiring medical intervention with bronchodilators cannot be included; 4. Immunosuppressive or systemic hormone therapy for immunosuppression within 2 weeks prior to randomization (dose >10 mg/day prednisone or other equipotent hormone); 5. Patients with active infection, unexplained fever >=38.5°C within 1 week prior to randomization, or white blood cell count >15 x 10^9/L at baseline : Therapeutic antibiotics given orally or intravenously within 2 weeks prior to randomization (patients receiving prophylactic antibiotics (e.g., for prevention of urinary tract infections or exacerbation of COPD are eligible for study participation); 6. Patients with congenital or acquired immune deficiency (e.g., HIV-infected); 7. Have received a live attenuated vaccine within 4 weeks prior to enrollment or anticipate the need for such a vaccine during systemic therapy or within 60 days of the last dose; 8. Have a history of gastrointestinal bleeding within 6 months prior to enrollment or have a clear tendency to gastrointestinal bleeding, e.g., at risk of bleeding or severe esophagogastric fundal varices, locally active gastrointestinal ulcerative foci, persistent positive fecal occult blood may not be enrolled (if fecal occult blood is positive in the baseline period, it may be retested, and if it is still positive after the retesting, gastroduodenoscopy (EGD) is required, and if EGD suggests a risk of bleeding). (esophagogastric fundal varices cannot be enrolled); 9. Patients with known hereditary or acquired bleeding (e.g. coagulopathy) or thrombotic tendency, e.g. hemophilia: currently receiving full-dose oral or injectable anticoagulant or thromboly
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate;Disease-Free Survival;Overall Survival; | — |
Countries
China
Contacts
Public ContactLi nan
The Third Affiliated Hospital of Naval Military Medical University
Outcome results
None listed