Neoadjuvant IMRT Combined With Camrelizumab and Apatinib for Resectable HCC With PVTT

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorYongyi Zeng

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Neoadjuvant intensity-modulated radiotherapy combined with perioperative camrelizumab and apatinib

    Combination product

    1. 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

33 Participants
are divided into 1 treatment group
Group A: Neoadjuvant intensity-modulated radiotherapy combined with perioperative camrelizumab and apatinibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
1 year

Secondary outcomes

1

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).

Time frame
up to 2 years
2

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).

Time frame
up to 2 years
3

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).

Time frame
up to 2 years
4

R0 resection rate

Major Pathological Response, defined as ≤10% viable tumor tissue in the surgical specimen at the time of tumor resection

Time frame
up to 3 months

Other outcomes

1

Surgical safety

30-day mortality rate post-surgery, surgical complications, reoperation rate, postoperative hospital stay, readmission rate.

Time frame
up to 3 months
2

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

Time frame
up to 2 years
3

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.

Time frame
up to 2 years

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