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Sintilimab Combined With Stereotactic Body Radiotherapy as Neoadjuvant Therapy for Resectable Hepatocellular

ConditionHCC
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorLei ZHAO

About this trial

This study is a prospective, randomized controlled, phase II trial evaluating the efficacy and safety of neoadjuvant therapy with Sintilimab combined with SBRT in patients with resectable hepatocellular carcinoma.

After meeting the inclusion and exclusion criteria and providing informed consent, eligible subjects will be randomly assigned to the experimental group or the control group:

* Experimental Group: Subjects will receive Sintilimab 200 mg via intravenous infusion on day 1 of each 3-week cycle, for a total of two cycles. This will be combined with SBRT, administered as 8 Gy per fraction for 3 fractions on days 1, 3, and 5. Surgery will be performed 4-6 weeks after the last treatment, following the assessment of the patient's condition. Postoperative adjuvant therapy with Sintilimab monotherapy (200 mg Q3W) will be administered until disease recurrence, death, intolerable toxicity, withdrawal of informed consent, initiation of new antitumor therapy, or other protocol-specified reasons occur, for a maximum of one year. * Control Group:Subjects will undergo surgery directly. Postoperative adjuvant therapy with Sintilimab monotherapy (200 mg Q3W) will be administered until disease recurrence, death, intolerable toxicity, withdrawal of informed consent, initiation of new antitumor therapy, or other protocol-specified reasons occur, for a maximum of one year.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent must be provided and signed prior to the implementation of any trial-related procedures.

Male or female subjects aged ≥18 years and ≤75 years.

ECOG PS score of 0-1.

BCLC 0-B.

Disqualifiers

History of any histologically/cytologically confirmed malignancy other than HCC.

History of hepatic encephalopathy, or history of liver transplantation.

Presence of any extrahepatic metastatic lesions.

Prior receipt of any systemic antitumor therapy for HCC, including treatment with antibodies such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 agents.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SBRT

    Procedure/Surgery

    SBRT :8 Gy per fraction for 3 fractions on days 1, 3, and 5.

  • Sintilimab

    Drug

    200mg ivgtt,D1,Q3W

  • Surgery

    Procedure/Surgery

    Surgery

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Sintilimab +Stereotactic Body Radiotherapy +surgeryExperimental treatment 3 interventions
Group B: controlOther 1 intervention

Trial outcomes

Primary outcomes

1

Three-year recurrence rate

the proportion of individuals who experience their first radiological recurrence or death (whichever occurs first) from the time of enrollment in the group until the 3-year time point.

Time frame
From date of resection until the date of first documented progression, assessed up to 3 years

Secondary outcomes

1

Five-year recurrence rate

the proportion of individuals who experience their first radiological recurrence or death (whichever occurs first) from the time of enrollment in the group until the 5-year time point.

Time frame
From date of resection until the date of first documented progression, assessed up to 5 years
2

Recurrence free survival

the time from the end of treatment to tumor recurrence or patient death.

Time frame
From date of resection until the date of first documented progression, assessed up to 3 years
3

Overall survival (OS)

as the time from enrollment to the death of the subject for any reason

Time frame
From date of resection until the date of death from any cause, assessed up to 5 years
4

Pathologic complete response (pCR)

The proportion of subjects whose postoperative pathological examination did not detect residual cancer cells

Time frame
Up to one year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lei ZHAO

Lead sponsor

Shandong Cancer Hospital and Institute

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: