Preliminary Efficacy and Safety of Pegylated Interferon Alpha-2b Combined With Targeted Immunotherapy in Patients With Unresectable Advanced Chronic Hepatitis B-related Hepatocellular Carcinoma: a Prospective, Real-world Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- One-year progression-free survival after treatment
研究概览
简要总结
This study is a prospective, real-world study intended to evaluate the efficacy and safety of pegylated interferon alpha-2b (PegIntron®) combined with targeted immunotherapy in patients with unresectable intermediate and advanced chronic hepatitis B-related hepatocellular carcinoma.
This study intends to enroll 20 patients with unresectable intermediate and advanced chronic hepatitis B-related hepatocellular carcinoma who have previously undergone and are currently receiving nucleoside (nucleotide) analog therapy. Subjects who meet the inclusion and exclusion criteria after evaluation will receive Pegasys® combined with targeted immunotherapy. Both targeted therapy and PD-1 inhibitors will be selected based on actual clinical decision-making, using standard therapeutic drugs recommended by the CSCO guidelines. During the study, each 6 weeks will be defined as a treatment cycle, and treatment will continue until disease progression or unacceptable toxicity occurs. Follow-up will be completed according to the protocol until the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must voluntarily enroll in the study, demonstrate the ability to understand and voluntarily sign the informed consent form, and adhere to the protocol requirements. In cases where the patient is unable to sign the informed consent form, their legal guardian or authorized agent must sign on their behalf.
- •Participants must be aged 18 years or older, with no restrictions on gender.
- •Participants must be patients with hepatocellular carcinoma (HCC) who have undergone pathological examination or received a clinical diagnosis, and have been surgically assessed as having intermediate or advanced unresectable HCC, with liver function classified as Child-Pugh A or B (score ≤ 7).
- •Participants must have at least one measurable lesion, as defined by the RECIST 1.1 criteria.
- •Participants must test positive for serum hepatitis B surface antigen (HBsAg).
- •Participants must have an Eastern Cooperative Oncology Group (ECOG) physical performance status score ranging from 0 to
- •Participants must have an expected survival time of 3 months or longer.
- •Participants must exhibit good organ function levels within one week prior to the first administration of the study drug, as evaluated by the investigator.
- •For females of childbearing potential, a negative pregnancy test result must be obtained within one week prior to the first administration of the study drug.
排除标准
- •Known to have had active malignancies other than HCC within the past 5 years or concurrently.
- •Having a documented history of gastrointestinal bleeding or a definite tendency towards gastrointestinal bleeding within 6 months prior to the initiation of study treatment.
- •Patients who have experienced abdominal fistula, gastrointestinal perforation, or intra-peritoneal abscess within 6 months before the commencement of the study treatment.
- •Occurrence of thrombosis or thromboembolic events within 6 months prior to the start of the study treatment.
- •Individuals with neuropsychiatric disorders, particularly those with a history of depression, anxiety, mania, schizophrenia, or a familial history of psychiatric disorders (especially those with a history of depression or a predisposition to depression).
- •Individuals with a history of severe cardiac disease, especially those with unstable or inadequately controlled cardiac conditions within the preceding 6 months.
结局指标
主要结局
One-year progression-free survival after treatment
时间窗: At 1 year
The proportion of patients who have not progressed or died from any cause within one year after the start of treatment.
Overall Survival (OS)
时间窗: From first dose of treatment to date of death due to any cause, assessed up to 36 months.
From first dose of treatment to date of death due to any cause, assessed up to 36 months.
次要结局
- Objective Response Rate (ORR)(At the time of best overall response, assessed up to 24 months.)
- HBsAg level, magnitude of decrease from baseline, kinetics, negativity rate (<0.05 IU/mL), and seroconversion rate(At baseline, Week 12, Week 24, Week 36, Week 48, and Week 96)
- Disease Control Rate (DCR)(From baseline until the end of treatment or disease progression, assessed up to 24 months.)
- HBV DNA levels, magnitude of decrease from baseline, and proportion of subjects with undetectable levels (among HBV DNA-positive patients)(At baseline, Week 12, Week 24, Week 48, and Week 96.)
- HBeAg levels, magnitude of decrease from baseline, seroconversion rate, and negativity rate (among HBeAg-positive patients)(t baseline, Week 12, Week 24, Week 48, and Week 96.)
- Change in Eastern Cooperative Oncology Group (ECOG) Performance Status Score from Baseline(At baseline, Week 12, Week 24, Week 48, and Week 96.)
研究者
Sizhen Wang
Associate Chief Physician
Jinling Hospital, China