Anatomic Versus Nonanatomic Liver Resection After Conversion Therapy for Hepatocellular Carcinoma
Anatomic Versus Non-anatomic Liver Resection After Successful Immune Checkpoint Inhibitor-Based Conversion Therapy for Initially Unresectable Hepatocellular Carcinoma: A Prospective Cohort Study
This prospective observational cohort study will compare the survival outcomes of anatomic liver resection (ALR) versus nonanatomic liver resection (NALR) in patients with initially unresectable hepatocellular carcinoma (HCC) who become eligible for resection following immune checkpoint inhibitor (ICI)-based conversion therapy. Emerging evidence suggests that surgical resection may provide a survival benefit for selected patients with initially unresectable HCC after conversion therapy; however, the optimal surgical approach for these patients remains unclear. This study aims to inform surgical decision-making in this setting. Participants will be included in one of two cohorts according to the procedure received: ALR or NALR. The primary outcome is the 2-year recurrence-free survival (RFS) rate. Participants will undergo regular imaging assessments and survival follow-up. The target enrollment is 874 participants, with approximately 437 planned for each cohort; because treatment allocation is not randomized, the actual cohort sizes may differ.
調査の概要
状態
条件
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前:Chenwei Wang
- 電話番号:020-87343114
- メール:wangchw@sysucc.org.cn
研究場所
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Guangdong
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Guangzhou、Guangdong、中国、510000
- 募集
- Sun Yat-sen University Cancer Center
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コンタクト:
- Chenwei Wang
- 電話番号:020-87343114
- メール:wangchw@sysucc.org.cn
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Patients with initially unresectable HCC who underwent liver resection after successful immune checkpoint inhibitor-based conversion therapy conversion therapy at the Sun Yat-sen University Cancer Center (SYSUCC)
説明
Inclusion Criteria:
- Clinical diagnosis of initially unresectable HCC
- Received conversion therapy based on PD-1/PD-L1 therapy.
- Two liver surgeons with associate senior or higher professional titles determine that R0 resection is feasible after conversion therapy.
- Child-Pugh class A liver function.
- ECOG performance status 0 or 1.
- Adequate organ and bone marrow function, based on laboratory tests within 7 days before enrollment: ANC ≥1.5 × 10^9/L; platelet count ≥75 × 10^9/L; hemoglobin ≥9.0 g/dL; total bilirubin ≤1.5 × ULN; ALT, AST, and ALP ≤3 × ULN; serum albumin ≥28 g/L; serum creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL/min by Cockcroft-Gault; urine protein <2+, or, if ≥2+ at baseline, 24-hour urine protein <1 g; INR and APTT ≤1.5 × ULN; TSH between the lower and upper limits of normal (if abnormal, FT3 and FT4 must be normal).
Exclusion Criteria:
- Any cancer treatment other than conversion therapy.
- Any of the following within 12 months before study start: myocardial infarction, severe/unstable angina, coronary artery bypass grafting, congestive heart failure, cerebrovascular accident (including transient ischemic attack), or pulmonary embolism; ongoing arrhythmia of CTCAE Grade 2 or higher; or QTc >450 ms in men or >470 ms in women.
- Renal insufficiency requiring peritoneal dialysis or hemodialysis.
- Severe dysfunction of another major organ.
- Prior diagnosis of a second primary malignancy.
- Known or new evidence of brain or leptomeningeal disease.
- Hemophilia or bleeding tendency, or therapeutic anticoagulation with coumarin derivatives.
- Prior organ transplantation.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 観測モデル:COHORT
- 時間の展望:PROSPECTIVE
コホートと介入
グループ/コホート |
|---|
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Anatomic Liver Resection (ALR)
Participants with HCC who undergo anatomic liver resection after conversion therapy. |
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Non-anatomic Liver Resection (NALR)
Participants with HCC who undergo nonanatomic liver resection after conversion therapy |
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
2-year recurrence-free survival (RFS) rate
時間枠:From enrollment to the end of treatment at 2 years
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From enrollment to the end of treatment at 2 years
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Recurrence-free survival (RFS)
時間枠:Time from study entry to disease recurrence or death from any cause, whichever occurs first, assessed up to 5 years.
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Time from study entry to disease recurrence or death from any cause, whichever occurs first. |
Time from study entry to disease recurrence or death from any cause, whichever occurs first, assessed up to 5 years.
|
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Overall survival (OS)
時間枠:Time from study entry to death from any cause, assessed up to 5 years.
|
Time from study entry to death from any cause |
Time from study entry to death from any cause, assessed up to 5 years.
|
|
Time to recurrence (TTR)
時間枠:Time from study entry to recurrence, assessed up to 5 years.
|
Time from study entry to recurrence |
Time from study entry to recurrence, assessed up to 5 years.
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- B2026-494-01
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