By InvitationNot Applicable

Survival Analysis of Surgical Resection Versus Observation in Patients With Initially uHCC Achieving CR After Systemic Therapy

China729 participantsStarted 2025-12-01

Plain-language summary

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

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

What they're measuring

three-year OS rate

Timeframe: "From date of enrollment until the date of date of death from any cause, assessed up to 100 months"

Trial details

NCT IDNCT07290764

SponsorFujian Provincial Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-03-01

View on ClinicalTrials.gov More Hepatocellular Carcinoma trials

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Survival Analysis of Surgical Resection Versus Observation in Patients With Initially uHCC Achieving CR After Systemic Therapy

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Survival Analysis of Surgical Resection Versus Observation in Patients With Initially uHCC Achieving CR After Systemic Therapy

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Exclusion criteria