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Local Consolidation After Sintilimab Plus Lenvatinib for Metastatic Liver Cancer

ConditionsHepatocellular Carcinoma (HCC)Metastases
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTongji Hospital

About this trial

This study evaluates whether comprehensive local consolidative therapy added to continued sintilimab plus lenvatinib improves survival compared with continued sintilimab plus lenvatinib alone in patients with oligo-extrahepatic metastatic hepatocellular carcinoma. All enrolled participants receive induction treatment with sintilimab plus lenvatinib for 4 cycles. Participants who achieve disease control and are confirmed by central multidisciplinary review to be feasible for complete consolidation are randomized in a 1:1 ratio to receive either comprehensive local consolidative therapy followed by continued systemic therapy or continued systemic therapy alone. The primary outcome is overall survival.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 to 75 years

Hepatocellular carcinoma confirmed by imaging and/or histology according to institutional diagnostic standards

Advanced or unresectable disease with extrahepatic metastases meeting protocol-defined oligo-extrahepatic metastatic disease criteria: 1 to 5 extrahepatic metastatic lesions and no more than 2 involved extrahepatic organs

At least 1 measurable lesion according to RECIST version 1.1

Disqualifiers

More than 5 extrahepatic metastatic lesions or more than 2 involved extrahepatic organs

Diffuse peritoneal seeding, leptomeningeal disease, or uncontrolled brain metastases

Main portal vein trunk invasion, extensive inferior vena cava or right atrial tumor thrombus, or disease considered unlikely to become fully consolidable after induction

Diffuse intrahepatic disease or liver tumor burden considered unlikely to be controllable with protocol-specified local treatment

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sintilimab

    Drug

    Sintilimab 200 mg administered as an intravenous infusion every 3 weeks during induction and continued after randomization until disease progression, unacceptable toxicity, withdrawal of consent, investigator decision, or a maximum duration of 24 months, according to protocol.

  • Lenvatinib

    Drug

    Lenvatinib administered orally once daily during induction and continued after randomization until disease progression or unacceptable toxicity. The recommended dose is 12 mg once daily for participants with body weight greater than or equal to 60 kg and 8 mg once daily for participants with body weight less than 60 kg. Dose interruption, reduction, and discontinuation are managed according to protocol and product labeling.

  • Comprehensive Local Consolidative Therapy

    Procedure/Surgery

    Protocol-specified comprehensive local consolidative therapy directed at all residual active lesions after induction treatment, including stereotactic body radiotherapy, thermal ablation, surgery, or a combination thereof, performed within 4 to 8 weeks after randomization.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Induction Sintilimab Plus Lenvatinib Followed by Comprehensive Local Consolidative Therapy and ContiExperimental treatment 3 interventions
Group B: Induction Sintilimab Plus Lenvatinib Followed by Continued Systemic Therapy AloneActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Overall Survival

Overall survival is defined as the time from randomization to death from any cause.

Time frame
From randomization until death from any cause, assessed up to 60 months

Secondary outcomes

1

Time to Strategy Failure

Time to strategy failure is defined as the time from randomization to progression, inability to continue the assigned treatment strategy, initiation of non-protocol antitumor therapy, or death.

Time frame
From randomization through 60 months
2

Time to Widespread Progression

Time to widespread progression is defined as the time from randomization to protocol-defined widespread disease progression or death.

Time frame
From randomization through 60 months

Other outcomes

Sponsors and contacts

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

Tongji Hospital

Lead sponsor

Source ClinicalTrials.gov

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