- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07927452
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.
Studienübersicht
Status
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Chenwei Wang
- Telefonnummer: 020-87343114
- E-Mail: wangchw@sysucc.org.cn
Studienorte
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Guangdong
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Guangzhou, Guangdong, China, 510000
- Rekrutierung
- Sun Yat-sen University Cancer Center
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Kontakt:
- Chenwei Wang
- Telefonnummer: 020-87343114
- E-Mail: wangchw@sysucc.org.cn
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
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)
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: COHORT
- Zeitperspektiven: PROSPECTIVE
Kohorten und Interventionen
Gruppe / Kohorte |
|---|
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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 |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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2-year recurrence-free survival (RFS) rate
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Recurrence-free survival (RFS)
Zeitfenster: 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)
Zeitfenster: Time from study entry to death from any cause, assessed up to 5 years.
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Time from study entry to death from any cause |
Time from study entry to death from any cause, assessed up to 5 years.
|
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Time to recurrence (TTR)
Zeitfenster: 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.
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- B2026-494-01
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