Hepatocellular CarcinomaNCT07243691
Study on the Therapeutic Effect of Different Infusion Times of Tislelizumab on Postoperative High-risk Hepatocellular Carcinoma
A study testing Tislelizumab: 200mg, intravenous infusion, Q3W in people with Hepatocellular Carcinoma, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial summary
Study on the therapeutic effect of different infusion times on tislelizumab in high-risk postoperative hepatocellular carcinoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Tislelizumab: 200mg, intravenous infusion, Q3W
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 15 Dec 2027
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) 18~75 years old (including boundary values).
- (2) The first diagnosis confirmed by histology or cytology is HCC.
- (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) 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) 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) The Child Pugh score for liver function is 5-6 points, and the liver function is grade A.
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- (7) The physical fitness status score of the Eastern Cancer Collaboration Group (ECOG) is ≤ 1.
- (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) 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) 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) The expected lifespan is ≥ 6 months.
- (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.
Who cannot join
- (1) The pathological diagnosis is non hepatocellular carcinoma.
- (2) Within one month after surgery, there may be intrahepatic or extrahepatic recurrence.
- (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) 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) Long term hormone users require long-term systemic hormone therapy (equivalent to>10 mg prednisone/day) or any other form of immunosuppressive therapy.
- (6) Within the first 3 months of enrollment, there has been clinically significant bleeding or bleeding tendency, or ongoing thrombolytic or anticoagulant therapy.
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- (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) 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) 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) 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) Clinically significant cardiovascular diseases; Suffering from hypertension, antihypertensive drugs cannot effectively control (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg).
- (12) Renal replacement therapy providers.
- (13) Individuals who have allergic reactions to any component of the investigational drug.
- (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) Pregnant or lactating female patients, and patients of childbearing age who refuse to receive contraceptive measures.
- (16) Vulnerable groups, including individuals with mental illness, cognitive impairment, critically ill patients, etc.
- (17) The researchers believe that patients who are not suitable to participate in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine (Qingchun Campus) 3 Qingchun Road East, Shangcheng District, Hangzhou, Zhejiang, China
Hangzhou, Zhejiang
Mingyu Chen, +86 187 5777 2223, mychen@zju.edu.cn
About this study
Study on the therapeutic effect of different infusion times on tislelizumab in high-risk postoperative hepatocellular carcinoma
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Tislelizumab: 200mg, intravenous infusion, Q3W
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tislelizumab: 200mg, intravenous infusion, Q3WDrug
Postoperative adjuvant therapy (maximum of 8 cycles, each cycle lasting 21 days):
- Tislelizumab: 200 mg, intravenous infusion, Q3W.
Based on previous preclinical and clinical studies on circadian rhythms and adaptive immune responses, blood samples will be collected from patients at 05:00-07:00, 11:00-13:00, 17:00-19:00, and 23:00-01:00 (every 6 hours) to analyze the subset classification of peripheral blood lymphocytes. This will help map the immune circadian rhythm and determine the optimal injection time (which will then be used as the dosing time).
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Tislelizumab: 200mg, intravenous infusion, Q3W Receives: Drug: Tislelizumab: 200mg, intravenous infusion, Q3W |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year recurrence-free survival (RFS) rate
Measured: 2year
Secondary outcomes (6)
recurrence-free survival (RFS)
Duration from surgery to the first recorded HCC recurrence or all-cause death (whichever occurs first)
Measured: From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Time to recurrence (TTR)
Defined as the time from enrollment to the first recorded disease recurrence assessed by the investigator,including the occurrence of local, regional, or metastatic HCC.
Measured: From date of randomization until the date of first documented progression, assessed up to 36 months
Overall survival (OS)
Time from surgery to date of death, irrespective of cause.
Measured: From date of surgery until the date of death from any cause, whichever came first, assessed up to 36 months
1-year recurrence-free survival (RFS) rate
Measured: 1 year
1-year overall survival (OS) rate
Measured: 1year
2-year overall survival (OS) rate
Measured: 2year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion15 Dec 2027 (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.
- More trials run by Sir Run Run Shaw HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07243691
- Sponsor's protocol ID
- SRRSH2025-0391
- Status last verified
- Nov 2025
- First submitted
- 8 Sep 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Therapeutic Effect of Different Infusion Times of Tislelizumab on Postoperative High-risk Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07243691
- Acronym / sponsor ID
- SRRSH2025-0391
- Conditions
- Hepatocellular Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 24 Nov 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.
Study on the therapeutic effect of different infusion times on tislelizumab in high-risk postoperative hepatocellular carcinoma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Tislelizumab: 200mg, intravenous infusion, Q3WTislelizumab: 200mg, intravenous infusion, Q3W |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- (1) 18~75 years old (including boundary values).
- (2) The first diagnosis confirmed by histology or cytology is HCC.
- (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) 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) 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.
Key exclusion criteria (17 listed)
- (1) The pathological diagnosis is non hepatocellular carcinoma.
- (2) Within one month after surgery, there may be intrahepatic or extrahepatic recurrence.
- (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) 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) Long term hormone users require long-term systemic hormone therapy (equivalent to>10 mg prednisone/day) or any other form of immunosuppressive therapy.
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 |
|---|---|---|
| Tislelizumab: 200mg, intravenous infusion, Q3WPostoperative adjuvant therapy (maximum of 8 cycles, each cycle lasting 21 days): - Tislelizumab: 200 mg, intravenous infusion, Q3W. Based on previous preclinical and clinical studies on circadian rhythms and adaptive immune responses, blood samples will be collected from patients at 05:00-07:00, 11:00-13:00, 17:00-19:00, and 23:00-01:00 (every 6 hours) to analyze the subset classification of peripheral blood lymphocytes. This will help map the immune circadian rhythm and determine the optimal injection time (which will then be used as the dosing time). | Drug | Cohort 1 |
Primary outcome
2-year recurrence-free survival (RFS) rate
Time frame: 2year
6 secondary outcomes
recurrence-free survival (RFS)
Time frame: From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Time to recurrence (TTR)
Time frame: From date of randomization until the date of first documented progression, assessed up to 36 months
Overall survival (OS)
Time frame: From date of surgery until the date of death from any cause, whichever came first, assessed up to 36 months
1-year recurrence-free survival (RFS) rate
Time frame: 1 year
1-year overall survival (OS) rate
Time frame: 1year
2-year overall survival (OS) rate
Time frame: 2year
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 24 Nov 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tislelizumab: 200mg, intravenous infusion, Q3W in people with Hepatocellular Carcinoma, run by Sir Run Run Shaw 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 12 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 24 Nov 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?
Contact Mingyu Chen (+86 187 5777 2223, mychen@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year recurrence-free survival (RFS) rate (time frame: 2year). 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 24 Nov 2025.