About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Single group
Treatments tested in this trial
Neoadjuvant intensity-modulated radiotherapy combined with perioperative camrelizumab and apatinib
Combination product1. 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).
Treatment groups
Trial outcomes
Primary outcomes
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).
Secondary outcomes
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).
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).
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).
R0 resection rate
Major Pathological Response, defined as ≤10% viable tumor tissue in the surgical specimen at the time of tumor resection
Other outcomes
Surgical safety
30-day mortality rate post-surgery, surgical complications, reoperation rate, postoperative hospital stay, readmission rate.
Safety of radiotherapy, camrelizumab and apatinib treatment
the incidence and severity of adverse events (AE) and serious adverse events (SAE) were determined according to NCI-CTCAE v5.0
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Yongyi Zeng
Lead sponsor
Meng Chao Hepatobiliary Hospital of Fujian Medical University
Sponsor institution