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A Platform Trial for Personalized and Adaptive Therapies in Hepatocellular Carcinoma

ConditionHepato Cellular Carcinoma (HCC)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFudan University

About this trial

This is a phase II, multi-arm, Bayesian adaptive platform trial designed to efficiently evaluate novel therapies for advanced hepatocellular carcinoma (HCC) after first-line treatment failure. The study aims to rapidly identify the most effective investigational regimens and discover predictive biomarker signatures (from tumor tissue, blood, and imaging) to guide personalized second-line therapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent obtained.

Age ≥ 18 years at time of study entry.

Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology/ cytology or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic patients.

Patients who have previously received first-line therapy with anti-PD-1/PD-L1 combined with anti-VEGF antibodies, or anti-PD-1/PD-L1 combined with TKI, or anti-PD-1/PD-L1 combined with anti-CTLA-4 antibodies and experienced disease progression; or disease recurrence within 6 months after completion of neoadjuvant/adjuvant immunotherapy.

Disqualifiers

Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.

Patients on a liver transplantation list or with advanced liver disease.

History of cardiac disease, including clinically significant gastrointestinal bleeding within 4 weeks prior to start of study treatment

Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months Prior to the first dose of study drug with the exception of thrombosis of a segmental portal vein.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lenvatinib

    Drug

    12 mg orally daily for body weight ≥ 60 kg; 8 mg orally daily for body weight \< 60 kg.

  • Regorafenib (BAY 73-4506)

    Drug

    160 mg orally once daily on Days 1-21 of a 28-day cycle.

  • Tislelizumab+TKI

    Drug

    Tislelizumab:200 mg administered intravenously (IV) on Day 1 of each 21-day cycle. Lenvatinib：8 mg orally daily；OR Regorafenib：80 mg orally once daily on Days 1-21 of a 28-day cycle.

  • HAIC+TKI

    Drug

    FOLFOX Regimen: Administered via the hepatic artery. Oxaliplatin: 85 mg/m² IV infusion from Hour 0-2 on Day 1. Leucovorin: 400 mg/m² IV infusion from Hour 2-3 on Day 1. Fluorouracil: 400 mg/m² IV bolus at Hour 3 on Day 1, followed by 2400 mg/m² as a continuous IV infusion over 24 hours. HAIC was repeated every 3 weeks for up to 4 cycles. Lenvatinib：8 mg orally daily；OR Regorafenib：80 mg orally once daily on Days 1-21 of a 28-day cycle.

  • HAIC + Tislelizumab+TKI

    Drug

    FOLFOX Regimen: Administered via the hepatic artery. Oxaliplatin: 85 mg/m² IV infusion from Hour 0-2 on Day 1. Leucovorin: 400 mg/m² IV infusion from Hour 2-3 on Day 1. Fluorouracil: 400 mg/m² IV bolus at Hour 3 on Day 1, followed by 2400 mg/m² as a continuous IV infusion over 24 hours.HAIC was repeated every 3 weeks for up to 4 cycles. Tislelizumab: 200 mg IV on Day 1 of each 21-day cycle. Lenvatinib：8 mg orally daily；OR Regorafenib：80 mg orally once daily on Days 1-21 of a 28-day cycle.

  • QL1706+TKI

    Drug

    QL1706:7.5 mg/kg IV on Day 1 of each 21-day cycle. Lenvatinib：8 mg orally daily；OR Regorafenib：80 mg orally once daily on Days 1-21 of a 28-day cycle.

  • HAIC + QL1706+TKI

    Drug

    FOLFOX Regimen: Administered via the hepatic artery. Oxaliplatin: 85 mg/m² IV infusion from Hour 0-2 on Day 1. Leucovorin: 400 mg/m² IV infusion from Hour 2-3 on Day 1. Fluorouracil: 400 mg/m² IV bolus at Hour 3 on Day 1, followed by 2400 mg/m² as a continuous IV infusion over 24 hours. HAIC was repeated every 3 weeks for up to 4 cycles. QL1706: 7.5 mg/kg IV on Day 1 of each 21-day cycle. Lenvatinib：8 mg orally daily；OR Regorafenib：80 mg orally once daily on Days 1-21 of a 28-day cycle.

  • TUDCA + Camrelizumab+TKI

    Drug

    Tauroursodeoxycholic Acid (TUDCA): 250 mg orally twice daily. Camrelizumab: 200 mg IV on Day 1 of each 14-day cycle. Lenvatinib：8 mg orally daily；OR Regorafenib：80 mg orally once daily on Days 1-21 of a 28-day cycle.

  • XELOX + QL1706+TKI

    Drug

    Oxaliplatin, 85 mg/m² IV infusion on Day 1 every 3 weeks; Capecitabine, 1000 mg/m2, orally twice daily on days 1 to 14 every 3 weeks. XELOX was repeated every 3 weeks for up to 4 cycles. QL1706: 7.5 mg/kg IV on Day 1 of each 21-day cycle. Lenvatinib：8 mg orally daily；OR Regorafenib：80 mg orally once daily on Days 1-21 of a 28-day cycle.

  • XELOX + Tislelizumab+TKI

    Drug

    Oxaliplatin, 85 mg/m² IV infusion on Day 1 every 3 weeks; Capecitabine, 1000 mg/m2, orally twice daily on days 1 to 14 every 3 weeks. XELOX was repeated every 3 weeks for up to 4 cycles. Tislelizumab: 200 mg IV on Day 1 of each 21-day cycle. Lenvatinib：8 mg orally daily；OR Regorafenib：80 mg orally once daily on Days 1-21 of a 28-day cycle.

Treatment groups

350 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Group A: TKI (Control Therapy)Active comparator 2 interventions
Group B: Tislelizumab+TKIExperimental treatment 1 intervention
Group C: HAIC+TKIExperimental treatment 1 intervention
Group D: HAIC + Tislelizumab+TKIExperimental treatment 1 intervention
Group E: QL1706+TKIExperimental treatment 1 intervention
Group F: HAIC + QL1706+TKIExperimental treatment 1 intervention
Group G: TUDCA + Camrelizumab+TKIExperimental treatment 1 intervention
Group H: XELOX + Tislelizumab+TKIExperimental treatment 1 intervention
Group I: XELOX + QL1706+TKIExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1

ORR is defined as the percentage of participants who have a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters). Responses are according to RECIST 1.1 as assessed by investigator.

Time frame
max 24 months

Secondary outcomes

1

Disease control rate (DCR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1

DCR is defined as the proportion of patients with complete response (CR), partial response (PR) and stable disease (SD).

Time frame
max 24 months
2

Duration of Response (DOR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1

DOR is defined as the time from first documented complete or partial response until disease progression, death from any cause, or censoring at date of last tumor assessment.

Time frame
max 24 months
3

Time to Response (TTR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1.

TTR is defined as the time from the start of treatment until the first objective observation of a response (either partial response, PR, or complete response, CR), provided that the response is subsequently confirmed.

Time frame
max 24 months
4

Progression Free Survival (PFS) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1.

PFS is defined as the time from study treatment to disease progression or all-cause death as assessed by the investigator (whichever occurs first).

Time frame
max 24 months

Other outcomes

Sponsors and contacts

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

Fudan University

Lead sponsor

Source ClinicalTrials.gov
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