- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Chenwei Wang
- Telefonnummer: 020-87343114
- E-post: wangchw@sysucc.org.cn
Studieorter
-
-
Guangdong
-
Guangzhou, Guangdong, Kina, 510000
- Rekrytering
- Sun Yat-sen University Cancer Center
-
Kontakt:
- Chenwei Wang
- Telefonnummer: 020-87343114
- E-post: wangchw@sysucc.org.cn
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
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)
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
|---|
|
Anatomic Liver Resection (ALR)
Participants with HCC who undergo anatomic liver resection after conversion therapy. |
|
Non-anatomic Liver Resection (NALR)
Participants with HCC who undergo nonanatomic liver resection after conversion therapy |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
2-year recurrence-free survival (RFS) rate
Tidsram: From enrollment to the end of treatment at 2 years
|
From enrollment to the end of treatment at 2 years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Recurrence-free survival (RFS)
Tidsram: Time from study entry to disease recurrence or death from any cause, whichever occurs first, assessed up to 5 years.
|
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.
|
|
Overall survival (OS)
Tidsram: 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)
Tidsram: 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.
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- B2026-494-01
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