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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant intensity-modulated radiotherapy combined with perioperative camrelizumab and apatinib | Experimental | Neoadjuvant intensity-modulated radiotherapy combined with perioperative camrelizumab and apatinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoadjuvant intensity-modulated radiotherapy combined with perioperative camrelizumab and apatinib | Combination Product |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical safety | 30-day mortality rate post-surgery, surgical complications, reoperation rate, postoperative hospital stay, readmission rate. | up to 3 months |
| Safety of radiotherapy, camrelizumab and apatinib treatment |
Inclusion Criteria:
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;
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:
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongyi Zeng, Professor | Contact | 0591-88112620 | lamp197311@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yongyi Zeng, Professor | Meng Chao Hepatobiliary Hospital of Fujian Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mengchao Hepatobiliary Hospital, Fujian Medical University | Recruiting | Fuzhou | Fujian | China |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C553458 | apatinib |
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|
| 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). |
| 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). | 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 | 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. | up to 3 months |
the incidence and severity of adverse events (AE) and serious adverse events (SAE) were determined according to NCI-CTCAE v5.0
| up to 2 years |
| Exploratory Endpoints | the potential association between changes in the tumor microenvironment and biomarkers with the efficacy of neoadjuvant intensity-modulated radiotherapy combined with perioperative camrelizumab and apatinib treatment. | up to 2 years |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |