Surgery Versus Maintenance After Conversion-therapy-Achieved Complete/Partial Response in Hepatocellular Carcinoma: a Prospective Multicenter Non-randomized Cohort Study
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Time to Treatment Failure (TTF) per RECIST v1.1
概览
简要总结
The "Surgery versus Maintenance after Conversion-therapy-achieved Complete/Partial Response in Hepatocellular Carcinoma (SWITCH)" study is a multicenter, open-label, prospective non-randomized cohort study with the protocol number SWITCH-01 (Version 0.1, dated October 5, 2025). Sponsored by West China Hospital of Sichuan University and led by Principal Investigator Wu Hong, the study involves 10 participating centers and has completed NCT registration. Its core objective is to evaluate and compare the efficacy and safety of two management strategies-surgical resection and maintenance therapy-in patients with hepatocellular carcinoma (HCC) who have achieved complete response (CR) or partial response (PR) after conversion therapy and are deemed eligible for curative liver resection (R0) by a multidisciplinary team (MDT). The study is designed to address the clinical dilemma of optimal management for initially unresectable HCC patients who attain favorable responses to conversion therapy, providing high-level evidence for clinical decision-making.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-80 years.
- •Diagnosed with locally advanced, metastatic, and/or initially unresectable hepatocellular carcinoma (uHCC) via histology/cytology or clinical criteria (AASLD standards for cirrhotic patients; histopathological confirmation required for non-cirrhotic patients).
- •Previously judged unresectable or inappropriate for resection by MDT during initial diagnosis or disease course, with at least one evaluable lesion per RECIST v1.
- •Completed conversion therapy \[systemic therapy (PD-1/PD-L1 ± TKI) ± local therapy (TACE/HAIC/radiation/ablation, etc.)\], achieved CR or PR (primarily assessed by mRECIST, with concurrent RECIST v1.1 documentation), and confirmed via re-evaluation with the same imaging modality ≥4 weeks later.
- •Meets necessary conditions for resection: Child-Pugh Class A liver function, ICG R15 \<30%, and future liver remnant (FLR) accounting for ≥40% of standard liver volume (SLV) in patients with chronic liver disease, hepatic parenchymal injury, or cirrhosis, or ≥30% in patients without liver fibrosis or cirrhosis.
- •For patients with previous portal vein/hepatic vein/inferior vena cava tumor thrombus (without atrial tumor thrombus), enrollment is permitted only if the thrombus has significantly regressed after conversion therapy, MDT confirms feasibility of R0 resection, and risks are acceptable.
- •ECOG performance status 0-
- •Adequate organ and bone marrow function, as evidenced by: hemoglobin ≥90g/L; absolute neutrophil count ≥1.5×10⁹/L; platelets ≥60×10⁹/L; total bilirubin ≤1.5×upper limit of normal (ULN); AST, ALT, and ALP ≤2.5×ULN; serum creatinine ≤1.5×ULN or estimated creatinine clearance ≥50ml/min (Cockcroft-Gault formula); urine protein \<(++) or 24-hour urine protein \<1.0g.
- •Normal coagulation function without active bleeding: INR ≤1.5×ULN; APTT ≤1.5×ULN.
- •For patients with active hepatitis B virus (HBV) infection: those already receiving anti-HBV therapy (per local standard treatment) must agree to continue during the study; those not receiving anti-HBV therapy must initiate treatment (per local standard treatment) during screening and agree to continue throughout the study.
排除标准
- •Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma-HCC.
- •Extrahepatic metastasis confirmed by chest, abdominal, and pelvic CT and/or MRI.
- •Inability to achieve R0 resection.
- •Previous liver transplantation or on the liver transplantation waiting list.
- •Decompensated cirrhosis (persistent or refractory ascites, hepatic encephalopathy, progressive jaundice, etc.); Child-Pugh Class B with score ≥8 or Class C; ALBI Grade
- •Significant and uncontrollable portal hypertension (e.g., markedly elevated HVPG with recurrent variceal bleeding, refractory ascites).
- •Active gastrointestinal bleeding within the past 4 weeks or uncorrectable coagulation disorders.
- •Active infection/sepsis or unresolved Grade ≥2 immune-related adverse events (irAEs).
- •Severe cardiopulmonary/renal insufficiency (e.g., NYHA Class III-IV, recent myocardial infarction/stroke, dialysis dependency).
- •Pregnancy or lactation.
研究组 & 干预措施
Surgical Resection (SR) cohort
干预措施: Surgical Resection (Other)
Maintenance Therapy (MT) cohort
干预措施: Maintenance Therapy Group (Other)
结局指标
主要结局
Time to Treatment Failure (TTF) per RECIST v1.1
时间窗: From date of enrollment until treatment failure, assessed up to 36 months
TTF is defined as the time from the date of enrollment to the date of first documented treatment failure, including local recurrence, intrahepatic progression, extrahepatic spread (EHS), or death from any cause. Tumor assessment is performed using CT or MRI evaluated by the Independent Review Facility (IRF) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
次要结局
- Time to Treatment Failure (TTF) per mRECIST(From date of enrollment until treatment failure, assessed up to 36 months)
- Overall Survival (OS)(From date of enrollment until death, assessed up to 36 months)
- 12-month Overall Survival (OS) Rate(At 12 months post-enrollment)
- Pattern of Recurrence or Progression(From date of enrollment until first recurrence/progression, assessed up to 36 months)
- Incidence of Adverse Events (AEs)(From date of enrollment through 90 days after the last dose of study treatment or surgery)
研究者
Kunlin Xie
Associate Professor
West China Hospital