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New treatment option for Hepatocellular Carcinoma
Official title Neoadjuvant IMRT Combined With Camrelizumab and Apatinib for Resectable HCC With PVTT
ClinicalTrials.gov ID: NCT06349317
What this study is testing
What is Neoadjuvant intensity-modulated radiotherapy combined with perioperative camrelizumab and apatinib?
Neoadjuvant intensity-modulated radiotherapy combined with perioperative camrelizumab and apatinib is an investigational medicine, given as an once-daily, being studied as a potential treatment for hepatocellular carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- 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;
You likely can't join if
- PVTT located in the portal vein branch opposite the tumor, or with inferior vena cava tumor thrombus, extrahepatic metastasis, or tumor invasion of...
- Known intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed-cell carcinoma, and fibrolamellar carcinoma; active malignant tumors other than HCC...
- Currently with interstitial pneumonia or interstitial lung disease, or history of interstitial lung disease requiring hormone treatment, or other...
- Active autoimmune disease or history of autoimmune disease that may recur, including but not limited to autoimmune hepatitis, interstitial pneumonia...
- Use of immunosuppressive drugs or systemic corticosteroids for the purpose of immunosuppression (dose \>10mg/day of prednisone or equivalent) within...
- 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...
See the full eligibility criteria
Who can 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...
- 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...
- 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...
- 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...
- 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...
- 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...
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- Uncontrolled clinical symptoms or diseases of the heart, such as: (1) heart failure of NYHA class II or above or echocardiography showing LVEF \ 450ms for males and \>470ms for females (QTc interval calculated using the...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, Fujian, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuzhou, Fujian, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.