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

December 17, 2025 updated by: Mao-Lin Yan, Fujian Provincial Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
729

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
three-year OS rate
Time Frame: "From date of enrollment until the date of date of death from any cause, assessed up to 100 months"
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
progression-free survival
Time Frame: "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"
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
Time Frame: From date of enrollment until the date of death from any cause, assessed up to 100 months
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
Time Frame: From date of enrollment until the date of death from any cause, assessed up to 100 months
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to drug-off
Time Frame: From date of enrollment until the date of drug-off or death from any cause, which come first, assessed up to 100 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fujian Provincial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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