Health TrialsbyHealthPanel

SIRT Versus cTACE for Unresectable HCC (CHANCE2506)

ConditionUnresectable Hepatocellular Carcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhongda Hospital

About this trial

To evaluate the efficacy and safety of yttrium-90 carbon microspheres versus cTACE in patients with unresectable hepatocellular carcinoma

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Eastern Cooperative Oncology Group performance status ≤ 1;

Expected survival time ≥ 3 months;

Confirmed hepatocellular carcinoma based on CNLC guidelines;

Without extrahepatic metastases, unresectable or refuse surgical resection;

Disqualifiers

With previous history of hepatic encephalopathy;

Extrahepatic disease or combined with other malignant tumors;

Infiltrative hepatocellular carcinoma ;

With prior antitumor therapies, including liver transplantation, hepatectomy, ablation, TACE, chemotherapy, radiotherapy, targeted therapy or immunotherapy;

Trial design

Design model

Parallel

Treatments tested in this trial

  • SIRT

    Procedure/Surgery

    Y-90 administered

  • cTACE

    Procedure/Surgery

    cTACE administered

Treatment groups

108 Participants
are divided into 2 treatment groups
Group A: SIRT GroupExperimental treatment 1 intervention
Group B: cTACE GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time to progression (TTP)

Evaluated by the independent image review committee (CTCAE 5.0)

Time frame
From enrollment to 54 weeks after the treatment

Secondary outcomes

1

Adverse events

Rates and degree of adverse events

Time frame
From enrollment to 54 weeks after the treatment
2

Severe adverse events

Rates of severe adverse events

Time frame
From the enrollment to 54 weeks after the treatment.
3

localized time to progression

Localized time to progression evaluated by the investigator

Time frame
From the enrollment to 54 weeks after the treatment.
4

Objective response rates (ORR)

Evaluated by the investigator

Time frame
From enrollment to 54 weeks after the treatment.

Other outcomes

Sponsors and contacts

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

Zhongda Hospital

Lead sponsor

Source ClinicalTrials.gov
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