Hepatocellular CarcinomaNCT07290764
Survival Analysis of Surgical Resection Versus Observation in Patients With Initially uHCC Achieving CR After Systemic Therapy
An observational study of Hepatocellular Carcinoma, run by Fujian Provincial Hospital at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 729 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 1 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with initially unresectable hepatocellular carcinoma, the tumor response reached complete remission after systematic treatment.
Who may be able to join
- 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
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- 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.
- No history of severe arrhythmia, heart failure, etc. There is no history of severe ventilation dysfunction or serious pulmonary infection
- 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
Who cannot join
- 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
- Patients who have received organ transplants in the past or are planning to receive organ transplants
- 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)
- 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
- 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)
- 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)
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- Patients with concurrent mental disorders; Has a history of abuse of psychotropic drugs, alcoholism and drug abuse
- Pregnant or lactating women
- Those who, as determined by the researchers, are not suitable to participate in this trial for other reasons
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Surgery
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Surgical Resection Versus Observation in Patients with Initially Unresectable Hepatocellular Carcinoma Achieving Complete Response After Systemic Therapy
| Study group | Role | What they receive |
|---|---|---|
| Surgical Resection | Patients who with initially unresectable hepatocellular carcinoma achieved complete response after conversion therapy received surgical resection Receives: Procedure: Surgery | |
| Observation | Patients who with initially unresectable hepatocellular carcinoma achieved complete response after conversion therapy didn't receive surgical resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
three-year OS rate
The ratio of the number of survivors from the start of systemic treatment until 3 years to the initial enrollment
Measured: "From date of enrollment until the date of date of death from any cause, assessed up to 100 months"
Secondary outcomes (3)
progression-free survival
The period from the initiation of systemic treatment until disease progression, death or loss to follow-up
Measured: "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
Measured: 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
Measured: From date of enrollment until the date of death from any cause, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start1 Dec 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 729 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Provincial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mao-Lin Yan, Fujian Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07290764
- Sponsor's protocol ID
- TALENP007
- Status last verified
- Dec 2025
- First submitted
- 23 Nov 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07290764
- Acronym / sponsor ID
- TALENP007
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 729 participants (estimated)
- Lead sponsor
- Fujian Provincial HospitalUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical Resection | – | Procedure: SurgeryPatients who with initially unresectable hepatocellular carcinoma achieved complete response after conversion therapy received surgical resection |
| Observation | – | –Patients who with initially unresectable hepatocellular carcinoma achieved complete response after conversion therapy didn't receive surgical resection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with initially unresectable hepatocellular carcinoma, the tumor response reached complete remission after systematic treatment.
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
- Patients who have received organ transplants in the past or are planning to receive organ transplants
- 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)
- 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
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgerySurgical Resection Versus Observation in Patients with Initially Unresectable Hepatocellular Carcinoma Achieving Complete Response After Systemic Therapy | Procedure or surgery | Surgical Resection |
Primary outcome
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
3 secondary outcomes
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"
Overall survival
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Fujian Provincial Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.