Hepatocellular Carcinoma of Barcelona Clinic of Liver Cancer Stage C
Conditions
Interventions
Experimental group:Carrelizumab and Apatinib Mesylate Combined with Radiation
Control group:Camrelizumab and Apatinib Mesylate
Sponsors
Guangxi Medical University Affiliated Tumor Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 70 years; 2.ECOG PS: 0-1 points; 3.Primary liver cancer patients diagnosed by histology or clinically diagnosed according to the American Association for the Study of Liver Diseases (AASLD) criteria; 4.Expected survival >=3 months; 5.Liver function Child-Pugh Grade A; 6.At least one measurable lesion; 7.The Barcelona HCC Staging System is stage C (BCLC-C) and meets one of the following criteria: (1)Combined with extrahepatic metastasis; (2)Combined with Cheng's type I or TYPE II portal vein carcinoma thrombus; (3)In patients with Cheng's type III portal vein tumor thrombus, one portal vein branch should be patency; 8.No previous systemic treatment including sorafenib, remvatinib, chemotherapy, etc.; 9.Previous local treatment (including radiofrequency or ablation, percutaneous ethanol or acetic acid injection, cryotherapy, high-intensity focused ultrasound, hepatic arterial chemoembolization, hepatic arterial embolization, etc.) for liver tumors with clear progression in the local treatment area (according to RECISTv1.1 criteria); 10.Baseline blood routine and biochemical indicators meet the following criteria: Hemoglobin >=90g/L; Absolute neutrophils count (ANC) >=1.5x10^9/L; Platelet 75 x 10^9 / L; ALT and AST=30g/L. 11.Female patients must meet the following requirements: (1)Menopausal (defined as absence of menstruation for at least 1 year with no confirmed cause other than menopause), or (2) surgically sterilized (removal of ovaries and/or uterus), or (3) fertile, but must meet the following criteria: Serum pregnancy test within 7 days prior to randomization must be negative and agree on an annual failure rate <1% contraception or abstinence (from the signing of the informed consent to at least 150 days after the last dosing of the trial drug) (annual failure rate <1% of contraceptives include bilateral tubal ligation, male sterilization, proper use of ovulation-inhibiting hormonal contraceptives, hormone-releasing intrauterine devices (IUDs) and copper containing devices (IUDs), and do not breastfeed; 12.Male patients must agree to abstain from sex or use contraceptives as follows: if the partner is a woman of reproductive age or if the partner is pregnant, the male patient must remain abstinent or use a condom to prevent exposure to the embryo for at least 150 days from the date of signing the informed consent until the last dosing of the experimental drug.The reliability of abstinence was evaluated based on the duration of the clinical trial, patient preferences, and daily lifestyle.Regular abstinence (e.g., calendar days, ovulation, basal body temperature, or post-ovulation contraceptive methods) and external ejaculation are unqualified contraceptive methods.
Exclusion criteria
Exclusion criteria: 1.Hepatobiliary cell carcinoma, mixed cell carcinoma, or fiberplate lamellar cell carcinoma; 2.The superior mesenteric vein is invaded by cancer thrombi, or the main portal vein cancer thrombi is present with bilateral branch obstruction; 3.Diffuse or multiple tumor invasion of both livers, expected normal Liver volume [liver-gtv]10mg/ day prednisone efficacy dose) or any other form of systemic immunosuppressive therapy; Except for inhaled or topical steroid doses in the absence of active autoimmune disease; 11.Severe known allergic reaction to PD-1 monoclonal antibody, its active ingredient and/or excipients (>= grade 3); 12.Any active infection requiring systemic antiinfective therapy occurred during the first 14 days of randomization. 13.Chinese medicine with anti-tumor indications had been used within 14 days before randomization; 14.Randomized to have been treated with live vaccine within the first 28 days, but inactivated viral vaccine for seasonal influenza is permitted; 15.Patients considered to be at risk for massive gastrointestinal bleeding or had the following diseases within the previous 6 months at random: (1)Esophagotracheal fistula, gastrointestinal perforation, abdominal fistula or intra-abdominal abscess; (2)Intestinal obstruction and/or previous clinical signs or symptoms of gastrointestinal obstruction, including incomplete obstruction related to pre-existing disease or requiring routine parenteral hydration, parenteral nutrition, or tube feeding; (3)Inflammatory process
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR);Progression-free Survival (PFS);Disease Control Rate (DCR);Time to Response;Duration of Remission;Rate of Adverse Reaction;Rate of Serious Adverse Reaction;Quality of Life (QOL); | — |
Countries
China
Contacts
Public ContactXiang Bangde
Guangxi Medical University Affiliated Tumor Hospital
Outcome results
None listed