Hepatocellular CarcinomaPhase 2NCT06349317
Neoadjuvant IMRT Combined With Camrelizumab and Apatinib for Resectable HCC With PVTT
A Phase 2 study testing Neoadjuvant intensity-modulated radiotherapy combined with perioperative camrelizumab and apatinib in people with Hepatocellular Carcinoma, run by Yongyi Zeng at 1 site in China.
Trial summary
This study is an open-label, single-arm prospective clinical trial that evaluates the efficacy and safety of neoadjuvant intensity-modulated radiotherapy combined with perioperative camrelizumab and apatinib in the treatment of resectable hepatocellular carcinoma with portal vein tumor thrombus. 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?
- Neoadjuvant intensity-modulated radiotherapy combined with perioperative camrelizumab and apatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 22 Apr 2024to Jun 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
- Signed written informed consent and able to comply with scheduled visits and related procedures;
- Age ≥18 and ≤75 years, regardless of gender;
- Patients with HCC who meet the clinical diagnostic criteria of China's "Guidelines for the Diagnosis and Treatment of Hepatocellular Carcinoma" (2022 Edition) or are diagnosed by biopsy, and have at least one measurable lesion according to the mRECIST criteria;
- Presence of portal vein tumor thrombus (PVTT) of Cheng's type I/II/III, with the primary tumor being resectable;
- Child-Pugh score of Class A;
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-1;
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- No prior antitumor treatment (such as surgery, radiotherapy, TACE, ablation, chemotherapy, targeted therapy, immunotherapy, or systemic therapy).
- For patients with hepatitis B virus (HBV) infection, testing for HBV-DNA is required; direct treatment initiation is allowed if HBV-DNA ≤2000 IU/mL; if HBV-DNA >2000 IU/mL, antiviral therapy should be administered for one week before starting the treatment; all HBV positive patients will receive continuous antiviral treatment throughout the study; patients with hepatitis C virus (HCV) RNA positive must undergo antiviral treatment as per the guidelines;
- Participants must provide a fresh tumor biopsy sample during the screening period (can be waived after discussion with the medical monitor) and blood samples for monitoring immune cells, cytokine levels, and other relevant immune status in the tumor microenvironment;
- Expected survival of ≥12 weeks;
- Adequate organ and marrow function, as defined by the following laboratory values:
- Hematology: Absolute Neutrophil Count ≥1.5×109/L; Platelets ≥80×109/L; Hemoglobin ≥90g/L;
- Liver function: Total bilirubin ≤3× upper limit of normal (ULN); Alanine Aminotransferase and Aspartate Aminotransferase ≤5×ULN; Serum albumin ≥30g/L;
- Renal function: Serum creatinine (Cr) ≤1.5×ULN, or for patients with Cr >1.5×ULN, creatinine clearance (CCr) ≥45 mL/min (Cockcroft-Gault formula); Urinalysis showing proteinuria <2+; For participants with baseline proteinuria ≥2+, a 24-hour urine collection and quantitative protein <1g is required;
- Coagulation: International Normalized Ratio or APTT ≤1.5×ULN;
- Females of childbearing potential must agree to abstain from heterosexual intercourse or use effective contraception from signing the informed consent until at least 120 days after the last dose of study medication. They must have a negative serum HCG test within 1 week before treatment and must not be breastfeeding. Females who have not reached menopause (≥12 months of amenorrhea without an alternative medical cause) and have not undergone sterilization (e.g., hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) are considered to be of childbearing potential;
- Male participants with partners of childbearing potential must agree to abstain from heterosexual intercourse or use reliable and effective contraceptive methods from the time of signing the informed consent until at least 120 days after the last dose of study medication. During the same period, male participants must also agree not to donate sperm. Male subjects whose partners are pregnant must use condoms and do not need to use other contraceptive methods.
Who cannot join
- PVTT located in the portal vein branch opposite the tumor, or with inferior vena cava tumor thrombus, extrahepatic metastasis, or tumor invasion of adjacent organs;
- Known intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed-cell carcinoma, and fibrolamellar carcinoma; active malignant tumors other than HCC within the past 5 years or concurrently, except for cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, and breast carcinoma in situ, which are allowed;
- Currently with interstitial pneumonia or interstitial lung disease, or history of interstitial lung disease requiring hormone treatment, or other conditions that may interfere with the judgement and management of immunotherapy-related pulmonary toxicity, such as pulmonary fibrosis, organizing pneumonia (e.g., obliterative bronchiolitis), pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or participants with active pneumonia or severe impairment of lung function shown on a chest CT during screening; active tuberculosis;
- Active autoimmune disease or history of autoimmune disease that may recur, including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (patients controllable with hormone replacement therapy are allowed); Patients with skin conditions that do not require systemic treatment, such as vitiligo, psoriasis, and alopecia, those with controlled Type I diabetes mellitus undergoing insulin therapy, or individuals whose childhood asthma has fully resolved with no need for intervention in adulthood, are allowed; patients requiring bronchodilators for medical intervention of asthma are not allowed;
- Use of immunosuppressive drugs or systemic corticosteroids for the purpose of immunosuppression (dose >10mg/day of prednisone or equivalent) within 2 weeks before the start of the study;
- Active infection, fever of unknown origin ≥38.5°C within 1 week before the study start, or baseline white blood cell count >15×10^9/L; therapeutic antibiotics orally or intravenously within 2 weeks before the study start (excluding prophylactic antibiotics given IV for no more than 48 hours);
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- Congenital or acquired immunodeficiency (e.g., HIV infection);
- Receipt of live attenuated vaccines within 4 weeks before the study start or expectation of needing such vaccines during the camrelizumab treatment period or within 60 days after the last dose of camrelizuma;
- Significant bleeding symptoms of clinical significance or a clear bleeding tendency within 6 months before the study start, such as gastrointestinal bleeding, hemorrhagic gastric ulcers, or vasculitis; if baseline fecal occult blood is positive, retesting is allowed, and if still positive, gastroduodenoscopy is required;
- Known genetic or acquired bleeding (e.g., coagulopathy) and thrombotic tendencies, such as hemophilia, coagulation mechanism disorders, thrombocytopenia, etc.; currently receiving full-dose oral or injectable anticoagulants or thrombolytic agents for therapeutic purposes (prophylactic use of low-dose aspirin, etc., is allowed);
- Arterial thromboembolic events within 6 months before the study start, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), CTCAE grade 3 or above deep vein thrombosis, pulmonary embolism, etc;
- Uncontrolled clinical symptoms or diseases of the heart, such as: (1) heart failure of NYHA class II or above or echocardiography showing LVEF <50%; (2) unstable angina; (3) myocardial infarction within 1 year before treatment; (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; (5) QTc > 450ms for males and >470ms for females (QTc interval calculated using the Fridericia formula; if QTc is abnormal, continuous testing three times at 2-minute intervals is allowed, taking the average value);
- Hypertension not well controlled with antihypertensive medication (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg based on the average of ≥2 blood pressure readings), allowing achievement of the above parameters through antihypertensive treatment; history of hypertensive crisis or hypertensive encephalopathy;
- Major vascular diseases within 6 months before the study start (e.g., requiring surgical repair or recent peripheral arterial thrombosis of an aneurysm);
- Severe, unhealed, or open wounds and active ulcers or untreated fractures;
- Major surgery (excluding diagnostic) within 4 weeks before the study start;
- Inability to swallow pills, malabsorption syndrome, or any condition affecting gastrointestinal absorption;
- Intestinal obstruction and/or clinical signs or symptoms of gastrointestinal obstruction, including partial obstructions requiring parenteral hydration, parenteral nutrition, or tube feeding related to the underlying disease, within 6 months before the study start. Patients with incomplete obstruction/obstruction syndrome/intestinal obstruction signs/symptoms at initial diagnosis who have undergone definitive (surgical) treatment to alleviate symptoms may be eligible for the study;
- Use of strong CYP3A4/CYP2C19 inducers, including rifampin (and its analogs) and Hypericum perforatum, or strong CYP3A4/CYP2C19 inhibitors within 2 weeks before the study start;
- Known allergy to any monoclonal antibody, antiangiogenic targeted drugs, or excipients;
- Participation in other drug clinical studies within 12 weeks before the study start.
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
Mengchao Hepatobiliary Hospital, Fujian Medical University
Fuzhou, Fujian
Yong yi Zeng
About this study
Official title: Neoadjuvant Intensity-modulated Radiotherapy Combined With Perioperative Camrelizumab and Apatinib in the Treatment of Resectable Hepatocellular Carcinoma Associated With Portal Vein Tumor Thrombus: a Single-arm Prospective Clinical Study
This study is an open-label, single-arm prospective clinical trial that evaluates the efficacy and safety of neoadjuvant intensity-modulated radiotherapy combined with perioperative camrelizumab and apatinib in the treatment of resectable hepatocellular carcinoma with portal vein tumor thrombus.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Neoadjuvant intensity-modulated radiotherapy combined with perioperative camrelizumab and apatinib
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant intensity-modulated radiotherapy combined with perioperative camrelizumab and apatinibCombination product
- Preoperative IMRT targeting PVTT and intrahepatic tumor lesions with a prescribed dose for 18Gy in 6 fractions delivered by using 6-MV X-rays with a linear accelerator at 5 fractions per week;
- Perioperative combination of camrelizumab and apatinib Preoperatively, camrelizumab (200mg, every 2 weeks) combined with apatinib (250mg, daily) for 2 cycles (2 weeks as one cycle); Postoperatively, camrelizumab (200mg, every 3 weeks) combined with apatinib (250mg, daily) for 8 cycles (3 weeks as one cycle).
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant intensity-modulated radiotherapy combined with perioperative camrelizumab and apatinib | Experimental | Neoadjuvant intensity-modulated radiotherapy combined with perioperative camrelizumab and apatinib Receives: Combination Product: Neoadjuvant intensity-modulated radiotherapy combined with perioperative camrelizumab and apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year Event-Free Survival (EFS) rate
EFS is defined as the time from the start of study treatment to the occurrence of tumor progression, relapse assessed by the modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria, death for any reason, or last follow-up (whichever occurs first).
Measured: 1 year
Secondary outcomes (5)
Event-Free Survival (EFS)
EFS is defined as the time from the start of study treatment to the occurrence of tumor progression, relapse assessed by the modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria, death for any reason, or last follow-up (whichever occurs first).
Measured: up to 2 years
Overall Survival (OS)
OS is defined as the time from the start of study treatment to death for any reason or the last follow-up (whichever occurs first).
Measured: up to 2 years
Disease-Free Survival (DFS)
DFS is defined as the time from hepatectomy to tumor progression, relapse assessed by mRECIST standards, death for any reason, or last follow-up (whichever occurs first).
Measured: up to 2 years
R0 resection rate
Major Pathological Response, defined as ≤10% viable tumor tissue in the surgical specimen at the time of tumor resection
Measured: up to 3 months
Overall Objective Response of primary liver tumor and PVTT
The assessment of primary liver tumors is consistent with mRECIST criteria; for PVTT, any downstaging in the Cheng's PVTT classification or any conspicuous restoration of blood flow in the portal vein were regarded as partial remission (PR) and any upstaging in the PVTT classification as progressive disease (PD). Otherwise, these outcomes are defined as Stable Disease (SD). If either primary liver tumor or PVTT is classified as PD, the overall response is defined as PD; if either the primary liver tumor or PVTT is PR and the other is SD, it is defined as PR.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start22 Apr 2024
- Primary completionMay 2026 (estimated)
- Study completionJun 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yongyi Zeng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yongyi Zeng, Meng Chao Hepatobiliary Hospital of Fujian Medical University
- Investigators
- Yongyi Zeng, Professor, Principal investigator, Meng Chao Hepatobiliary Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06349317
- Sponsor's protocol ID
- 2024-005
- Status last verified
- Sep 2025
- First submitted
- 31 Mar 2024
- Last updated
- 29 Sep 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 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Intensity-modulated Radiotherapy Combined With Perioperative Camrelizumab and Apatinib in the Treatment of Resectable Hepatocellular Carcinoma Associated With Portal Vein Tumor Thrombus: a Single-arm Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT06349317
- Acronym / sponsor ID
- 2024-005
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Yongyi ZengUniversity, hospital or other
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 5 Apr 2024 (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 is an open-label, single-arm prospective clinical trial that evaluates the efficacy and safety of neoadjuvant intensity-modulated radiotherapy combined with perioperative camrelizumab and apatinib in the treatment of resectable hepatocellular carcinoma with portal vein tumor thrombus.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant intensity-modulated radiotherapy combined with perioperative camrelizumab and apatinib | Experimental | Combination Product: Neoadjuvant intensity-modulated radiotherapy combined with perioperative camrelizumab and apatinibNeoadjuvant intensity-modulated radiotherapy combined with perioperative camrelizumab and apatinib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Signed written informed consent and able to comply with scheduled visits and related procedures;
- Age ≥18 and ≤75 years, regardless of gender;
- Patients with HCC who meet the clinical diagnostic criteria of China's "Guidelines for the Diagnosis and Treatment of Hepatocellular Carcinoma" (2022 Edition) or are diagnosed by biopsy, and have at least one measurable lesion according to the mRECIST criteria;
- Presence of portal vein tumor thrombus (PVTT) of Cheng's type I/II/III, with the primary tumor being resectable;
- Child-Pugh score of Class A;
Key exclusion criteria (21 listed)
- PVTT located in the portal vein branch opposite the tumor, or with inferior vena cava tumor thrombus, extrahepatic metastasis, or tumor invasion of adjacent organs;
- Known intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed-cell carcinoma, and fibrolamellar carcinoma; active malignant tumors other than HCC within the past 5 years or concurrently, except for cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, and breast carcinoma in situ, which are allowed;
- Currently with interstitial pneumonia or interstitial lung disease, or history of interstitial lung disease requiring hormone treatment, or other conditions that may interfere with the judgement and management of immunotherapy-related pulmonary toxicity, such as pulmonary fibrosis, organizing pneumonia (e.g., obliterative bronchiolitis), pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or participants with active pneumonia or severe impairment of lung function shown on a chest CT during screening; active tuberculosis;
- Active autoimmune disease or history of autoimmune disease that may recur, including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (patients controllable with hormone replacement therapy are allowed); Patients with skin conditions that do not require systemic treatment, such as vitiligo, psoriasis, and alopecia, those with controlled Type I diabetes mellitus undergoing insulin therapy, or individuals whose childhood asthma has fully resolved with no need for intervention in adulthood, are allowed; patients requiring bronchodilators for medical intervention of asthma are not allowed;
- Use of immunosuppressive drugs or systemic corticosteroids for the purpose of immunosuppression (dose >10mg/day of prednisone or equivalent) within 2 weeks before the start of the study;
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 |
|---|---|---|
| Neoadjuvant intensity-modulated radiotherapy combined with perioperative camrelizumab and apatinib1. Preoperative IMRT targeting PVTT and intrahepatic tumor lesions with a prescribed dose for 18Gy in 6 fractions delivered by using 6-MV X-rays with a linear accelerator at 5 fractions per week; 2. Perioperative combination of camrelizumab and apatinib Preoperatively, camrelizumab (200mg, every 2 weeks) combined with apatinib (250mg, daily) for 2 cycles (2 weeks as one cycle); Postoperatively, camrelizumab (200mg, every 3 weeks) combined with apatinib (250mg, daily) for 8 cycles (3 weeks as one cycle). | Combination product | Neoadjuvant intensity-modulated radiotherapy combined with perioperative camrelizumab and apatinib |
Primary outcome
1-year Event-Free Survival (EFS) rate
Time frame: 1 year
EFS is defined as the time from the start of study treatment to the occurrence of tumor progression, relapse assessed by the modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria, death for any reason, or last follow-up (whichever occurs first).
5 secondary outcomes
Event-Free Survival (EFS)
Time frame: up to 2 years
Overall Survival (OS)
Time frame: up to 2 years
Disease-Free Survival (DFS)
Time frame: up to 2 years
R0 resection rate
Time frame: up to 3 months
Overall Objective Response of primary liver tumor and PVTT
Time frame: up to 3 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 29 Sep 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.
Yongyi Zeng, Professor principal investigator
Meng Chao Hepatobiliary Hospital of Fujian Medical University
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 Neoadjuvant intensity-modulated radiotherapy combined with perioperative camrelizumab and apatinib in people with Hepatocellular Carcinoma, run by Yongyi Zeng 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 17 inclusion and 21 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 29 Sep 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?
Contact Yongyi Zeng, Professor (0591-88112620, lamp197311@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year Event-Free Survival (EFS) rate (time frame: 1 year). 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 29 Sep 2025.