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

Yongyi Zeng1 site in 1 country33 target enrollmentApril 22, 2024

ConditionsHepatocellular Carcinoma

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Hepatocellular Carcinoma
Sponsor: Yongyi Zeng
Enrollment: 33
Locations: 1
Primary Endpoint: 1-year Event-Free Survival (EFS) rate
Status: Recruiting
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

April 22, 2024

End Date

June 1, 2026

Last Updated

7 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Yongyi Zeng

Responsible Party

Sponsor Investigator

Principal Investigator

Yongyi Zeng

Director

Meng Chao Hepatobiliary Hospital of Fujian Medical University

Eligibility Criteria

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;

Exclusion Criteria

•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);
•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);

Outcomes

Primary Outcomes

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).