Hepatocellular CarcinomaPhase 2NCT06031285
Perioperative Sintilimab Plus Bevacizumab Biosimilar and TACE-HAIC for HCC Patients With PVTT: A Phase-2 Clinical Trial
A Phase 2 study testing Sintilimab in people with Hepatocellular Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
Although resection provided survival benefit for selected HCC patients with PVTT, the recurrence rate is still high for those patients. It is still unknown whether perioperative Sintilimab, a PD-1antibody, plus bevacizumab biosimilar and TACE-HAIC will improve the survival for those patients. 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?
- Sintilimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 30 Dec 2026
- Phase
- Phase 2
- 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
Who may be able to join
- Clinically diagnosed or pathologically confirmed resectable advanced hepatocellular carcinoma, at least one measurable focus without local treatment (according to mRECIST requirements);
- Child-Pugh score ≤ 6 points (Child-Pugh A);
- BCLC staging is stage C; PVTT classification is combined with PVTT (VP1-2), and a single lesion in the liver (or multiple lesions with diameter) ≤ 10cm of primary liver cancer.
- Newly diagnosed patients who have not received targeted therapy or immunotherapy in the past;
- ECOG score: 0～1 (see Annex 1 for ECOG scoring criteria);
- Expected survival period ≥ 12 weeks;
- The functions of vital organs meet the following requirements (no blood components, cell growth factors and other corrective treatment drugs are allowed within 14 days before the first administration):
Who cannot join
- The patient has any active autoimmune disease or a history of autoimmune disease;
- The patient is using systemic therapy or local treatment for HCC before enrollment;
- Severe allergic reaction to other monoclonal antibodies;
- Those with a known history of central nervous system metastasis or hepatic encephalopathy;
- Patients whose liver tumor burden is greater than 50% of the total liver volume, or who have received liver transplantation in the past;
- Ascites with clinical symptoms, those who need puncture, drainage, or those who have received ascites drainage within the past 3 months, except those who have only a small amount of ascites on imaging but not accompanied by clinical symptoms;
Show all 13Show fewer
- Suffer from high blood pressure and cannot be well controlled by antihypertensive drugs (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg);
- Uncontrolled cardiac clinical symptoms or diseases, such as: NYHA level 2 or higher heart failure, unstable angina pectoris, myocardial infarction occurred within 1 year, clinically significant supraventricular or ventricular arrhythmia requires treatment or intervention , QTc>450ms (male); QTc>470ms (female);
- Abnormal coagulation function (INR>2.0, PT>16s), have bleeding tendency or are receiving thrombolysis or anticoagulation therapy, and allow the preventive use of low-dose aspirin and low molecular heparin;
- Significant clinically bleeding symptoms or clear bleeding tendency occurred within 3 months before randomization, such as pertussis/hemoptysis 2.5ml or more, gastrointestinal bleeding, esophageal and gastric varices with bleeding risk, hemorrhagic stomach Ulcer or vasculitis, etc., if the stool occult blood is positive at the baseline, it can be re-examined. If it is still positive after the re-examination, a gastroscopy is required. If the gastroscope shows severe esophageal and gastric varices, it cannot be included in the group (3 before the group) Except those who have undergone gastroscopy within a month or less to exclude such cases);
- Arterial/venous thrombosis events that occurred within 6 months before randomization, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;
- Known genetic or acquired bleeding and thrombotic tendency (such as hemophilia patients, coagulation dysfunction, thrombocytopenia, etc.); Urine routine test showed urine protein ≥ ++ and confirmed 24-hour urine protein content> 1.0 g;
- The patient suffered from other malignant tumors in the past 3 years or at the same time (except for cured skin basal cell carcinoma and cervical carcinoma in situ); Patients with bone metastases who received palliative radiotherapy within 4 weeks before participating in the study >5% of the bone marrow area; The patient has previously received other anti-PD-1 antibody therapy or other immunotherapy against PD-1/PD-L1, or has previously received targeted therapy; Live vaccine may be vaccinated less than 4 weeks before study medication or may be administered during the study period; According to the judgment of the investigator, the patient has other factors that may affect the results of the study or cause the study to be terminated halfway, such as alcoholism, drug abuse, other serious diseases (including mental illness) that require combined treatment, and serious laboratory tests
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
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Jiliang Qiu, +862087342651, qiujl@sysucc.org.cn
About this study
Official title: Perioperative Sintilimab Plus Bevacizumab Biosimilar and Transarterial Embolization, Hepatic Artery Infusion Chemotherapy (TACE-HAIC) for Hepatocellular Carcinoma Patients With Portal Vein Tumor Thrombus (PVTT): A Phase-2 Clinical Trial
Although resection provided survival benefit for selected HCC patients with PVTT, the recurrence rate is still high for those patients. It is still unknown whether perioperative Sintilimab, a PD-1antibody, plus bevacizumab biosimilar and TACE-HAIC will improve the survival for those patients. We initialed this phase 2 clinical trial to prove the perioperative therapy.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Sintilimab
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabDrug
Also called bevacizumab biosimilar
sintilimab (200 mg intravenous infusion), a bevacizumab biosimilar (15 mg/kg intravenous infusion), and TACE-HAIC (c-TACE, FOLFOX-based HAIC).
| Study group | Role | What they receive |
|---|---|---|
| Perioperative of Sinitilimab, bevacizumab biosimilar plus TACE-HAIC for PVTT-HCC | Experimental | Patients received a preoperative regimen comprising 2 to 3 cycles of combination therapy: sintilimab (200 mg intravenous infusion), a bevacizumab biosimilar (15 mg/kg intravenous infusion), and TACE-HAIC. One more cycle of sintilimab (200 mg IV) was administered before hepatic resection. Commencing 1 month post-resection, patients received 5-6 cycles of adjuvant therapy: sintilimab (200 mg intravenous infusion) and the bevacizumab biosimilar (15 mg/kg intravenous infusion). Receives: Drug: Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
RFS, recurrence-free survival
RFS was defined as the time from the date of treatment to that of first recurrence or death.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start1 Sep 2023
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 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.
- More trials run by Sun Yat-sen UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Two cycles of Sinitilimab plus bevacizumab biosimilar and TACE-HAIC were administrated before resection, six months adjuvant Sinitilimab plus bevacizumab biosimilar.
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunfei Yuan, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06031285
- Sponsor's protocol ID
- B2023-262
- Status last verified
- Jul 2025
- First submitted
- 4 Sep 2023
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- 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 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Sintilimab Plus Bevacizumab Biosimilar and Transarterial Embolization, Hepatic Artery Infusion Chemotherapy (TACE-HAIC) for Hepatocellular Carcinoma Patients With Portal Vein Tumor Thrombus (PVTT): A Phase-2 Clinical Trial
- ClinicalTrials.gov ID
- NCT06031285
- Acronym / sponsor ID
- B2023-262
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 11 Sep 2023 (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.
Although resection provided survival benefit for selected HCC patients with PVTT, the recurrence rate is still high for those patients. It is still unknown whether perioperative Sintilimab, a PD-1antibody, plus bevacizumab biosimilar and TACE-HAIC will improve the survival for those patients. We initialed this phase 2 clinical trial to prove the perioperative therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Two cycles of Sinitilimab plus bevacizumab biosimilar and TACE-HAIC were administrated before resection, six months adjuvant Sinitilimab plus bevacizumab biosimilar.
| Arm | Type | Receives |
|---|---|---|
| Perioperative of Sinitilimab, bevacizumab biosimilar plus TACE-HAIC for PVTT-HCC | Experimental | Drug: SintilimabPatients received a preoperative regimen comprising 2 to 3 cycles of combination therapy: sintilimab (200 mg intravenous infusion), a bevacizumab biosimilar (15 mg/kg intravenous infusion), and TACE-HAIC. One more cycle of sintilimab (200 mg IV) was administered before hepatic resection. Commencing 1 month post-resection, patients received 5-6 cycles of adjuvant therapy: sintilimab (200 mg intravenous infusion) and the bevacizumab biosimilar (15 mg/kg intravenous infusion). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Clinically diagnosed or pathologically confirmed resectable advanced hepatocellular carcinoma, at least one measurable focus without local treatment (according to mRECIST requirements);
- Child-Pugh score ≤ 6 points (Child-Pugh A);
- BCLC staging is stage C; PVTT classification is combined with PVTT (VP1-2), and a single lesion in the liver (or multiple lesions with diameter) ≤ 10cm of primary liver cancer.
- Newly diagnosed patients who have not received targeted therapy or immunotherapy in the past;
- ECOG score: 0～1 (see Annex 1 for ECOG scoring criteria);
Key exclusion criteria (13 listed)
- The patient has any active autoimmune disease or a history of autoimmune disease;
- The patient is using systemic therapy or local treatment for HCC before enrollment;
- Severe allergic reaction to other monoclonal antibodies;
- Those with a known history of central nervous system metastasis or hepatic encephalopathy;
- Patients whose liver tumor burden is greater than 50% of the total liver volume, or who have received liver transplantation in the past;
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 |
|---|---|---|
| SintilimabAlso: bevacizumab biosimilarsintilimab (200 mg intravenous infusion), a bevacizumab biosimilar (15 mg/kg intravenous infusion), and TACE-HAIC (c-TACE, FOLFOX-based HAIC). | Drug | Perioperative of Sinitilimab, bevacizumab biosimilar plus TACE-HAIC for PVTT-HCC |
Primary outcome
RFS, recurrence-free survival
Time frame: 6 month
RFS was defined as the time from the date of treatment to that of first recurrence or death.
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 23 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Hepatocellular Carcinoma
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
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 Phase 2 study testing Sintilimab in people with Hepatocellular Carcinoma, run by Sun Yat-sen University 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 7 inclusion and 13 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 23 Jul 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RFS, recurrence-free survival (time frame: 6 month). 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 23 Jul 2025.