NCT04344158进行中（未招募）3 期
A Randomized, Controlled, Open-label, Multicenter Phase III Clinical Trial of AK105 Injection Combined With Anlotinib Hydrochloride Capsules Versus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma (HCC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 648
- 试验地点
- 81
- 主要终点
- Overall survival (OS)
研究概览
简要总结
This is a randomized, controlled, open-label, multicenter study to evaluate efficacy of AK105 injection combined with Anlotinib Hydrochloride Capsules versus Sorafenib. Patients are treated with AK105 injection combined with Anlotinib Hydrochloride Capsules or Sorafenib, with 2:1 random ratio. Every 21 days is a treatment cycle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years old; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; Life expectancy ≥ 3 months.
- •Histopathology or cytology confirmed as HCC.
- •Has not received any systematic treatment for HCC.
- •Stage B or C in the Barcelona Clinic Liver Cancer (BCLC) classification, and is not suitable for surgery or local treatment, or progress after surgery or local treatment.
- •Child-Pugh liver function classification : A or B (≤7 points).
- •Central nervous system metastasis has no clinical symptoms or is stable at least 4 weeks after treatment.
- •Quantification of HBV DNA <500IU/ml or 2500 Copys/ml, and anti-HBV therapy should be given for at least 2 weeks before the first administration; Quantification of HCV RNA is positive must complete antiviral therapy at least 1 month before the first administration.
- •Patients who progress after local treatment should be at least 4 weeks after the end of local treatment.
- •Radiotherapy for bone metastases accompanied by clinical symptoms must be completed at least 2 weeks before the first administration.
- •Has at least one measurable lesion.
- •Adequate organ function.
- •Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ；No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization.
- •13.Understood and signed an informed consent form.
排除标准
- •Histopathology or cytology confirmed as fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, hepatobiliary cell carcinoma, mixed liver cancer, etc.
- •Has used anti-angiogenic drugs such as anlotinib, apatinib, lenvatinib, sorafenib, sunitinib, bevacizumab, or related immunotherapy drugs for PD-1, PD-L1, etc.
- •Has received systemic treatment such as chemotherapy and biological therapy.
- •Has a history of hepatic encephalopathy.
- •According to imaging examination, the portal vein has invasion of cancer embolus, inferior vena cava or heart involvement.
- •Hepatitis B with hepatitis C or hepatitis D infection.
- •Has received or planned to receive organ transplantation.
- •Has other malignant tumors within 5 years.
- •Has multiple factors affecting oral medication.
- •Has uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
- •Has any bleeding or bleeding events ≥grade 3 in the first 4 weeks before the first administration.
- •Has unhealed wounds, fractures, active gastric and duodenal ulcers, positive continuous fecal occult blood, ulcerative colitis in the first 4 weeks before the first administration.
- •Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade
- •Has received surgery, or unhealed wounds within 4 weeks before the first administration.
- •Has drug abuse history that unable to abstain from or mental disorders.
- •Has any serious and / or uncontrolled disease.
- •Has received vaccination or attenuated vaccine within 4 weeks prior to the first administration.
- •Has received anti-tumor Traditional Chinese Medicine within 2 weeks before the first administration.
- •Severe hypersensitivity after administration of other monoclonal antibodies.
- •Has any active autoimmune disease or history of autoimmune disease. 21.Immunosuppressant or systemic or absorbable local hormone therapy is required to achieve the aim of immunosuppression (dose > 10mg/ day prednisone or other therapeutic hormones) and is still used within 2 weeks after the first administration.
- •22.Has participated in other anticancer drug clinical trials within 4 weeks. 23.Portal hypertension with high risk of hemorrhage, or have red sign confirmed by gastroscopy.
- •24.According to the judgement of the investigators, there are other factors that may lead to the termination of the study.
研究组 & 干预措施
AK105 combined with Anlotinib
Experimental
AK105 200mg intravenously (IV) on day 1 of each 21-day cycle plus Anlotinib capsules 10mg given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).
干预措施: AK105 Injection (Drug)
AK105 combined with Anlotinib
Experimental
AK105 200mg intravenously (IV) on day 1 of each 21-day cycle plus Anlotinib capsules 10mg given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).
干预措施: Anlotinib Hydrochloride Capsules (Drug)
Sorafenib Tosylate Tablets
Active Comparator
Sorafenib Tosylate Tablets 400mg given orally, twice daily in 21-day cycle.
干预措施: Sorafenib Tosylate Tablets (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: Up to 96 weeks
OS defined as the time from the first dose to death from any cause. Subjects who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
次要结局
- Disease control rate（DCR）(Up to 96 weeks)
- Duration of Response (DOR)(Up to 96 weeks)
- Progression-free survival (PFS)(Up to 96 weeks)
- Overall response rate（ORR）(Up to 96 weeks)
研究者
研究点 (81)
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