Can timing of infusion beat liver cancer recurrence?
NCT ID NCT07243691
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether giving the drug tislelizumab at different infusion times after surgery can help prevent liver cancer from coming back in high-risk patients. About 33 adults aged 18-75 with early-stage liver cancer who had curative surgery will take part. The main goal is to see how long they stay cancer-free after treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 33 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. (1) 18\~75 years old (including boundary values). 2. (2) The first diagnosis confirmed by histology or cytology is HCC. 3. (3) Barcelona Clinical Liver Cancer (BCLC) stage A-B has undergone curative resection of the tumor, with no extrahepatic metastasis or adjacent organ invasion before surgery. 4. (4) Must meet at least one of the high-risk recurrence risk criteria (as follows): Characteristics of high-risk recurrent liver cancer after surgery: preoperative single lesion\>5cm; MVI positive; Preoperative presence of sub lesions; Intraoperative margin\<1cm. 5. (5) After one month of postoperative follow-up, there was no recurrence and no systemic treatment for HCC (systemic chemotherapy, immunotherapy, targeted therapy, or other treatments for HCC) was received. 6. (6) The Child Pugh score for liver function is 5-6 points, and the liver function is grade A. 7. (7) The physical fitness status score of the Eastern Cancer Collaboration Group (ECOG) is ≤ 1. 8. (8) Research on organ function levels that meet the requirements before the first use of medication; The functional indicators of important organs meet the following requirements: serum total bilirubin ≤ 51.3 μ mol/L or 3 mg/dL; Hemoglobin ≥ 90g/L, neutrophil count ≥ 1.5 × 10/L, platelet count ≥ 100 × 10/L; aspartate or alanine aminotransferase ≤ 5 times the upper limit of normal (ULN), alkaline phosphatase ≤ 2.5 ULN, serum albumin ≥ 30g/L; Serum creatinine\<1.5 ULN; International normalized ratio (INR) ≤ 2 or prothrombin time (PT) exceeding the upper limit of the normal range ≤ 6 seconds; Serum creatinine ≤ 1.5 ULN, creatinine clearance rate ≥ 60 mL/min. 9. (9) Women who have the ability to conceive (i.e. physically capable of pregnancy) must agree to take effective contraceptive measures during the study period and within 120 days after the last dose of Trastuzumab treatment, and test negative for pregnancy within 7 days before the first dose of the study drug; Men who are capable of reproduction must agree to take effective contraceptive measures during the study period and within 120 days after the last administration of Trastuzumab. 10. (10) If the subject is infected with HBV or HCV The following conditions must be met: for inactive/asymptomatic HBV carriers, in the chronic phase; Active HBV (HBV deoxyribonucleic acid (DNA)\<500 IU/mL (or 2500 copies/mL) during screening) should be treated according to treatment guidelines. Patients receiving antiviral therapy during screening should receive treatment\>2 weeks prior to screening and continue treatment during the study period. For subjects infected with HCV: Confirmation of infection is based on detectable HCV ribonucleic acid RNA, and antiviral treatment must be completed before enrollment. 11. (11) The expected lifespan is ≥ 6 months. 12. (12) Voluntarily participate in this study and sign an informed consent form. If the subject does not have the ability to read the informed consent form (such as illiterate subjects), a witness must witness the informed process and sign the informed consent form. Exclusion Criteria: 1. (1) The pathological diagnosis is non hepatocellular carcinoma. 2. (2) Within one month after surgery, there may be intrahepatic or extrahepatic recurrence. 3. (3) Previously received anti-tumor treatment plans such as chemotherapy, radiotherapy, radiofrequency ablation, interventional therapy, targeted therapy, and immunotherapy for liver cancer (excluding previous non tumor related surgeries and diagnostic biopsies). 4. (4) The viral load is limited to hepatitis B virus (HBV) DNA\>2500 copies/ml, hepatitis C virus (HCV) RNA\>1000, and no treatment has been received. 5. (5) Long term hormone users require long-term systemic hormone therapy (equivalent to\>10 mg prednisone/day) or any other form of immunosuppressive therapy. 6. (6) Within the first 3 months of enrollment, there has been clinically significant bleeding or bleeding tendency, or ongoing thrombolytic or anticoagulant therapy. 7. (7) Patients with complete intestinal obstruction and those with incomplete intestinal obstruction in need of treatment (but those who relieve obstruction through fistula or stent placement can be included). 8. (8) Active severe clinical infections (\>grade 2, NCI-CTCAE V5.0), including: active tuberculosis; Having a history of active tuberculosis infection for more than 1 year prior to enrollment; Has not received formal anti tuberculosis treatment or tuberculosis is still active. 9. (9) History of active immunodeficiency or autoimmune disease and/or possible recurrence of immunodeficiency or autoimmune disease in the past or long-term use of steroids. 10. (10) Uncontrolled diabetes (fasting blood glucose ≥ 10 mmol/L), severe lung disease (such as acute lung disease, pulmonary fibrosis affecting lung function, interstitial lung disease, but the recovered radiation pneumonia is excluded). 11. (11) Clinically significant cardiovascular diseases; Suffering from hypertension, antihypertensive drugs cannot effectively control (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg). 12. (12) Renal replacement therapy providers. 13. (13) Individuals who have allergic reactions to any component of the investigational drug. 14. (14) Within the past 5 years or currently suffering from other malignant tumors (excluding cured cervical carcinoma in situ, uterine carcinoma in situ, and non melanoma skin cancer). 15. (15) Pregnant or lactating female patients, and patients of childbearing age who refuse to receive contraceptive measures. 16. (16) Vulnerable groups, including individuals with mental illness, cognitive impairment, critically ill patients, etc. 17. (17) The researchers believe that patients who are not suitable to participate in this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Sir Run Run Shaw Hospital, Zhejiang University School of Medicine (Qingchun Campus) 3 Qingchun Road East, Shangcheng District, Hangzhou, Zhejiang, China
RECRUITINGHangzhou, Zhejiang, China
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