Stereotactic Body Radiation Therapy for the Safety and Prognosis of Small Intrahepatic Recurrent HCC

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

Primary liver cancer is one of the common malignant tumors in China, of which hepatocellular carcinoma (HCC) accounts for 85%-90%. It is worth noting that the recurrence rate of liver cancer is greater than 10% at 1 year after surgery, while the recurrence rate in 5 years reaches 70-80%.

Stereotactic body radiation therapy (SBRT) refers to a kind of radiotherapy technology to achieve a steep dose gradient and achieve high-precision position and high-dose fractionated irradiation. The rapid dose drop-down enables SBRT to maximize the protection of normal tissues around the tumor, and it often requires only 1-5 times of high-dose fractionated irradiation to complete the course of treatment.SBRT may play an important role in the treatment of small intrahepatic recurrence HCC, but there is still a lack of evidence of high-level prospective studies.

We intend to conduct a single-center, prospective, clinical study to further elaborate the efficacy and safety of SBRT in the treatment of small intrahepatic recurrent HCC.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Clinical or pathological diagnosis of HCC without lymph node and distant metastasis.

Disqualifiers

1. Patients who have undergone antitumor therapy for liver cancer. 2. Obvious cirrhosis, recent hematemesis due to portal hypertension, Child-Pugh score ≥10 points.

Trial design

Design model

Single group

Treatments tested in this trial

  • Stereotactic body radiation therapy

    Radiation

    Stereotactic body radiotherapy for small intrahepatic recurrent HCC. Radiation dose: Greater than or equal to 40Gy/4-5F, complete treatment within 1 week.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Stereotactic body radiation therapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Local control rate(LC)

The treatment efficacy is assessed by calculation of local control rate of irradiated locations according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria (complete response + partial response + stable disease)

Time frame
up to 24 months after SBRT

Secondary outcomes

1

Short time Safety profile of SBRT

Toxicities appeared during SBRT treatment and up to 3 months after SBRT. Toxicities will be assessed by the evaluation of intensity and incidence of the Adverse Events (AE) displayed by patients. The intensity of each AE will be classified according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Time frame
up to 3 months after SBRT
2

Overall response rate (ORR)

According to RECIST v1.1, the proportion of patients with at least one complete response (CR) or partial response (PR) (%)

Time frame
up to 24 months after SBRT
3

Overall survival (OS)

The time between the date of SBRT and death from any cause

Time frame
up to 24 months
4

Local recurrence rate (LRR)

Rate of intrahepatic hepatocellular carcinoma recurrence

Time frame
up to 24 months after SBRT

Other outcomes

Sponsors and contacts

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