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Safety and Efficacy of Paclitaxel Liposome Arterial Infusion Combined With Systemic Therapy for Second-Line Treatment of Advanced Liver Cancer

ConditionAdvanced Hepatocellular Carcinoma (HCC)
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCSPC ZhongQi Pharmaceutical Technology Co., Ltd.

About this trial

This trial is an open-label, dose-escalation, and randomized controlled Phase Ib/II clinical study for second-line treatment in participants with advanced hepatocellular carcinoma (HCC). Its primary objective is to evaluate the safety, tolerability, pharmacokinetic profiles, and efficacy of transcatheter arterial infusion of HA131 combined with systemic therapy in the second-line treatment of participants with advanced HCC.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1.Aged 18 to 75 years (inclusive), regardless of gender;

2.Diagnosed with hepatocellular carcinoma (HCC) by histopathology, cytology, or imaging;

3.HCC classified as B/C stage per BCLC (Barcelona Clinic Liver Cancer) staging system, or IIb/IIIa/IIIb stage as defined in Clinical Practice Guidelines for Primary Liver Cancer (2024 Edition) (organized by the Guidelines Committee of the Chinese Society of Clinical Oncology, 2024);

4.Child-Pugh liver function class ≤ 7 points within 7 days prior to the first dose administration;

Disqualifiers

1.Pathologically confirmed fibrolamellar hepatocellular carcinoma (HCC), sarcomatoid HCC, cholangiocellular carcinoma, or combined hepatocellular-cholangiocarcinoma;

2.History of liver surgery and/or local treatment for HCC within 4 weeks prior to the first dose;

3.Previous antineoplastic treatment with lenvatinib;

4.Use of traditional Chinese medicine (TCM) preparations with indicated efficacy for anti-HCC within 14 days prior to the first dose; having received immune checkpoint inhibitors within 28 days prior to the first dose.

Trial design

Design model

Parallel

Treatments tested in this trial

  • HA131

    Drug

    Phase Ib: Dose escalation. Phase II: Administration at the RP2D dose determined in Phase Ib. Transcatheter Arterial Infusion.

  • Enlonstobart Injection

    Drug

    Administered via intravenous infusion.

  • Pembrolizumab Injection

    Drug

    Administered via intravenous infusion.

  • Lenvatinib Mesilate Capsules

    Drug

    Administered orally.

Treatment groups

116 Participants
are divided into 5 treatment groups
Group A: Phase Ib Cohort 1Experimental treatment 2 interventions
Group B: Phase Ib Cohort 2Experimental treatment 3 interventions
Group C: Phase Ib Cohort 3Experimental treatment 3 interventions
Group D: Phase II Experimental ArmExperimental treatment 3 interventions
Group E: Phase II Control ArmActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Phase Ib-DLT

Incidence of Dose-Limiting Toxicity

Time frame
3years
2

Phase Ib- AE

Adverse Event

Time frame
3years
3

Phase II- ORR

Overall Response Rate

Time frame
3years

Secondary outcomes

1

Phase Ib- ORR

Overall Response Rate

Time frame
3years
2

Phase Ib- DCR

Disease Control Rate

Time frame
3years
3

Phase Ib- DoR

Duration of Response

Time frame
3years
4

Phase Ib- TTR

Time to Response

Time frame
3years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

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