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

Survival Analysis of Surgical Resection Versus Observation in Patients With Initially Unresectable Hepatocellular Carcinoma Achieving Complete Response After Systemic Therapy: A Multicenter, Real-World Study

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Procedure: Surgery

• Study Type: Observational
• Enrollment (Estimated): 729

Contacts and Locations

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China
      • Fuzhou University Affiliated Provincial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients with initially unresectable hepatocellular carcinoma, the tumor response reached complete remission after systematic treatment.

Description

Inclusion Criteria:

1. Aged between 18 and 75
2. Child-Pugh: A/B grade
3. ECOG score: ≤1 point
4. 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).
5. 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)
6. 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
7. The expected survival time is more than three months
8. 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.
9. No history of severe arrhythmia, heart failure, etc. There is no history of severe ventilation dysfunction or serious pulmonary infection
10. Fertile women should agree to use contraceptive measures during the medication period and for 6 months after the medication is stopped; within 7 days before the study enrollment, the serum or urine pregnancy test must be negative, and the patient must be non-lactating. For male patients, they should agree to use contraceptive measures during the study period and for 6 months after the study is over

Exclusion Criteria:

1. Those who have had other malignant tumor histories within the past 5 years or simultaneously, but have been cured, such as skin basal cell carcinoma, cervical carcinoma in situ, and thyroid papillary carcinoma, are excluded
2. Patients who have received organ transplants in the past or are planning to receive organ transplants
3. Patients with any active autoimmune diseases or those with autoimmune diseases and expected recurrence (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases and syndromes)
4. Have a history of immune deficiency; Patients who are currently undergoing immunosuppressant or systemic hormone therapy to achieve immunosuppressive effects and are still using them within two weeks prior to signing the informed consent form
5. Known hereditary or acquired bleeding disorders (such as coagulation dysfunction) or thrombosis tendencies, such as in patients with hemophilia; currently using or having used full-dose oral or injectable anticoagulant or thrombolytic drugs for therapeutic purposes (allowing for the preventive use of low-dose aspirin or low-molecular-weight heparin within 10 days prior to the start of the study treatment)
6. Within 4 weeks prior to the first use of the investigational drug, there was a severe infection, such as severe pneumonia requiring hospitalization, bacteremia, infection complications, etc.; the baseline chest imaging examination indicated active pulmonary inflammation; within 2 weeks prior to the first use of the investigational drug, there were symptoms and signs of infection or the need for oral or intravenous antibiotic treatment (excluding the use of antibiotics for prophylaxis)
7. Patients with concurrent mental disorders; Has a history of abuse of psychotropic drugs, alcoholism and drug abuse
8. Pregnant or lactating women
9. Those who, as determined by the researchers, are not suitable to participate in this trial for other reasons

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Surgical Resection; Patients who with initially unresectable hepatocellular carcinoma achieved complete response after conversion therapy received surgical resection	Procedure: Surgery; Surgical Resection Versus Observation in Patients with Initially Unresectable Hepatocellular Carcinoma Achieving Complete Response After Systemic Therapy
Observation; Patients who with initially unresectable hepatocellular carcinoma achieved complete response after conversion therapy didn't receive surgical resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
three-year OS rate	The ratio of the number of survivors from the start of systemic treatment until 3 years to the initial enrollment	"From date of enrollment until the date of date of death from any cause, assessed up to 100 months"

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression-free survival	The period from the initiation of systemic treatment until disease progression, death or loss to follow-up	"From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months"
Overall survival	The time from the start of systemic treatment until death or loss to follow-up	From date of enrollment until the date of death from any cause, assessed up to 100 months
Treatment-related adverse events	The incidence rate, occurrence spectrum and severity of adverse events (AE) and serious adverse events (SAE), as well as the outliers of laboratory indicators, were judged according to the NCI-CTCAE V5.0 standard. Dose suspension rate and dose termination rate caused by adverse events	From date of enrollment until the date of death from any cause, assessed up to 100 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to drug-off	The time from the initiation of systemic treatment to the assessment of clinical complete response of the tumor and the subsequent discontinuation of systemic treatment	From date of enrollment until the date of drug-off or death from any cause, which come first, assessed up to 100 months

Collaborators and Investigators

• Sponsor: Fujian Provincial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: November 23, 2025
• First Submitted That Met QC Criteria: December 17, 2025
• First Posted (Actual): December 18, 2025

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Surgical Procedures, Operative
• Other Study ID Numbers: TALENP007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data that support the findings of this study are not publicly available due to privacy reasons but are available from the corresponding author upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No