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Adjuvant PD-1 Inhibitor for Patients With Early-stage Hepatocellular Carcinoma Following Microwave Ablation

ConditionHepatocellular Carcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChen Xiaoping

About this trial

For early-stage hepatocellular carcinoma, i.e. Barcelona Clinical Liver Cancer Stage 0, ablation is the standard treatment with a comparable prognosis and less risk of ablation compared with liver resection. However, ablation is demanding on the surgeon and patients often face early recurrence if ablation is not complete. Therefore, it is necessary to find reasonable adjuvant treatment to consolidate the effect of microwave therapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18-75 years

Pathological type is HCC, BCLC stage 0-A

No extrahepatic HCC

No radiographic recurrence at 2-4 weeks after ablation

Disqualifiers

Any history of other malignant tumors or recurrent HCC

Any preoperative treatment for HCC including local and systemic therapy

Any acute active infectious diseases, active or history of autoimmune disease, or immune deficiency

Any persistent serious ablation-related complications

Trial design

Design model

Parallel

Treatments tested in this trial

  • PD-1 Inhibitors

    Drug

    Patients in the intervention group received post-operative adjuvant PD-1 inhibitor therapy, 240 mg intravenously every three weeks for nine cycles

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: PD-1 inhibitor adjuvant therapy groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Disease-free survival

Disease-free survival was defined as the period from inclusion in the study until tumor recurrence, death from any cause.

Time frame
From date of include in this research until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 60 months

Secondary outcomes

1

Overall survival

Overall survival was defined as the period from study inclusion until death from any cause.

Time frame
From date of include in this research until the date of death from any cause, whichever came first, assessed up to 60 months
2

Adverse effects

Adverse reactions are defined as any reaction during treatment that is inconsistent with the purpose of the treatment.

Time frame
6 months

Other outcomes

Sponsors and contacts

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

Chen Xiaoping

Lead sponsor

Tongji Hospital

Sponsor institution

Source ClinicalTrials.gov
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