NCT07290764
Enrolling By Invitation
不适用
Survival Analysis of Surgical Resection Versus Observation in Patients With Initially Unresectable Hepatocellular Carcinoma Achieving Complete Response After Systemic Therapy: A Multicenter, Real-World Study
概览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 729
- 试验地点
- 1
- 主要终点
- three-year OS rate
概览
简要总结
This study aims to further explore the survival benefits of surgical resection after achieving CR in initial uHCC after systemic treatment and the timing of discontinuing systemic treatment
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Aged between 18 and 75
- •Child-Pugh: A/B grade
- •ECOG score: ≤1 point
- •The clinical or pathological diagnosis is consistent with primary HCC, and it has been evaluated by two senior hepatobiliary surgeons as surgically unresectable (including multiple intrahepatic lesions, local vascular invasion, local lymph node metastasis, and distant metastasis).
- •According to the mRECIST criteria, the patient has at least one measurable lesion (the long diameter of the measurable lesion on CT/MRI scans is ≥10mm, and the measurable lesion has not previously received local treatments such as interventional therapy, radiotherapy, or cryotherapy)
- •Patients who achieved CR in tumor response after conversion therapy (based on systemic therapy) (rCR definition: The lesion is completely necrotic as evaluated by enhanced CT/MRI according to the mRECIST criteria；cCR is defined as: reaching rCR according to mRECIST criteria, having no distant metastatic lesions, normal AFP and DCP indicators, and maintaining the above criteria for ≥4weeks); Moreover, it can be surgically removed, with no contraindications for surgery or anesthesia
- •The expected survival time is more than three months
- •The functional indicators of important organs should meet the following requirements: · Blood routine: Absolute neutrophil count ≥ 1.5 × 109/L, Hb ≥ 9.0 g/L, PLT ≥ 75 × 109/L; · Liver function: Total bilirubin ≤ 1.5 times the upper limit of normal value (ULN) (for those with obstructive jaundice, after biliary drainage, it should be ≤ 2.5 times ULN); Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) ≤ 5 times ULN, Albumin ≥ 30 g/L; · Kidney function: Serum creatinine ≤ 1.5 mg/dL, Creatinine clearance rate ≥ 60 ml/min; · Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 times ULN.
- •No history of severe arrhythmia, heart failure, etc. There is no history of severe ventilation dysfunction or serious pulmonary infection
- •Fertile women should agree to use contraceptive measures during the medication period and for 6 months after the medication is stopped; within 7 days before the study enrollment, the serum or urine pregnancy test must be negative, and the patient must be non-lactating. For male patients, they should agree to use contraceptive measures during the study period and for 6 months after the study is over
排除标准
- •Those who have had other malignant tumor histories within the past 5 years or simultaneously, but have been cured, such as skin basal cell carcinoma, cervical carcinoma in situ, and thyroid papillary carcinoma, are excluded
- •Patients who have received organ transplants in the past or are planning to receive organ transplants
- •Patients with any active autoimmune diseases or those with autoimmune diseases and expected recurrence (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases and syndromes)
- •Have a history of immune deficiency; Patients who are currently undergoing immunosuppressant or systemic hormone therapy to achieve immunosuppressive effects and are still using them within two weeks prior to signing the informed consent form
- •Known hereditary or acquired bleeding disorders (such as coagulation dysfunction) or thrombosis tendencies, such as in patients with hemophilia; currently using or having used full-dose oral or injectable anticoagulant or thrombolytic drugs for therapeutic purposes (allowing for the preventive use of low-dose aspirin or low-molecular-weight heparin within 10 days prior to the start of the study treatment)
- •Within 4 weeks prior to the first use of the investigational drug, there was a severe infection, such as severe pneumonia requiring hospitalization, bacteremia, infection complications, etc.; the baseline chest imaging examination indicated active pulmonary inflammation; within 2 weeks prior to the first use of the investigational drug, there were symptoms and signs of infection or the need for oral or intravenous antibiotic treatment (excluding the use of antibiotics for prophylaxis)
- •Patients with concurrent mental disorders; Has a history of abuse of psychotropic drugs, alcoholism and drug abuse
- •Pregnant or lactating women
- •Those who, as determined by the researchers, are not suitable to participate in this trial for other reasons
结局指标
主要结局
three-year OS rate
时间窗: "From date of enrollment until the date of date of death from any cause, assessed up to 100 months"
The ratio of the number of survivors from the start of systemic treatment until 3 years to the initial enrollment
次要结局
- progression-free survival("From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months")
- Overall survival(From date of enrollment until the date of death from any cause, assessed up to 100 months)
- Treatment-related adverse events(From date of enrollment until the date of death from any cause, assessed up to 100 months)
研究者
Mao-Lin Yan
professor
Fujian Provincial Hospital
研究点 (1)
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