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A Platform Trial for Personalized and Adaptive Therapies in Hepatocellular Carcinoma | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE2

A Platform Trial for Personalized and Adaptive Therapies in Hepatocellular Carcinoma

The HCC-SIGHT: A Therapy Platform Trial for Hepatocellular Carcinoma Guided by Stratification Imaging and Genetic Horizon Testing

NCT07328009•Fudan University

View on ClinicalTrials.gov

Summary

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.

Detailed Description

This open-label, adaptive platform trial addresses the lack of effective second-line therapies for advanced HCC. Multiple experimental regimens will be evaluated against a common control arm. The study employs a Bayesian adaptive design. Patient randomization probabilities will favor regimens showing better interim efficacy (primary endpoint: objective response rate). Underperforming regimens will be dropped, and new ones may be added over time. A key objective is to identify predictive biomarker signatures. Baseline and on-treatment biomarker assessments (including tumor molecular profiling, ctDNA, and quantitative imaging features) will be analyzed to define patient subsets most likely to respond to each therapy. Regimens with a high predictive probability of success will graduate for further development. Those with low probability of benefit will be discontinued. This design enables rapid, biomarker-informed therapy screening for second-line HCC.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
•At least one measurable (per RECIST v1.1) target lesion that has not been previously treated with local therapy or, if the target lesion is within the field of previous local therapy, has subsequently progressed in accordance with RECIST v1.1.
•Child-Pugh scores 5-7, performance status (PS) ≤ 2 (ECOG scale).
•Subjects with chronic HBV infection must have HBV DNA viral load \< 100 IU/mL at screening. In addition, they must be on antiviral therapy per regional standard of care guidelines prior to initiation of study therapy.
•Life expectancy of at least 12 weeks.
•Adequate blood count, liver-enzymes, and renal function: absolute neutrophil count ≥ 1,500/L, platelets ≥60 x103/L; Total bilirubin ≤ 3x upper normal limit; Aspartate Aminotransferase (SGOT), Alanine aminotransferase (SGPT) ≤ 5 x upper normal limit (ULN); International normalized ratio (INR) ≤1.25; Albumin ≥ 31 g/dL; Serum Creatinine ≤ 1.5 x institutional ULN or creatinine clearance (CrCl) ≥ 30 mL/min (if using the Cockcroft-Gault formula)
•Female patients with reproductive potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial.
+1 more criteria

Exclusion Criteria

•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.
•Patients with second primary cancer, except adequately treated basal skin cancer or carcinoma in-situ of the cervix.
•Immunocompromised patients, e.g. patients who are known to be serologically positive for human immunodeficiency virus (HIV).
•Participation in another clinical study with an investigational product during the last 30 days before inclusion or 7 half-lifes of previously used trial medication, whichever is longer.
•Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study Treatment or interpretation of patient safety or study results, including but not limited to: a) history of interstitial lung disease b) Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) coinfection (i.e double infection) c) known acute or chronic pancreatitis d) active tuberculosis e) any other active infection (viral, fungal or bacterial) requiring systemic therapy f) history of allogeneic tissue/solid organ transplant g) diagnosis of immunodeficiency or patient is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of treatment. h) Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Exceptions: Subjects with vitiligo, hypothyroidism, diabetes mellitus type I or resolved childhood asthma/atopy are an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with Hashimoto thyroiditis, hypothyroidism stable on hormone replacement or psoriasis not requiring treatment are not excluded from the study. i) Live vaccine within 30 days prior to the first dose of treatment or during study treatment. j) History or clinical evidence of Central Nervous System (CNS) metastases Exceptions are: Subjects who have completed local therapy and who meet both of the following criteria: I. are asymptomatic and II. have no requirement for steroids 6 weeks prior to start of treatment. Screening with CNS imaging (CT or MRI) is required only if clinically indicated or if the subject has a history of CNS.
•Medication that is known to interfere with any of the agents applied in the trial.
•Any other efficacious cancer treatment except protocol specified treatment at study start.
+3 more criteria

Locations (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

January 25, 2026

Primary Completion Date

January 15, 2029

Completion Date

January 15, 2029

Last Updated

January 21, 2026

Enrollment

350

ESTIMATED participants

Conditions

Hepato Cellular Carcinoma (HCC)

Interventions

Lenvatinib

DRUG

Regorafenib (BAY 73-4506)

DRUG

Tislelizumab+TKI

DRUG

HAIC+TKI

DRUG

HAIC + Tislelizumab+TKI

DRUG

QL1706+TKI

DRUG

HAIC + QL1706+TKI

DRUG

TUDCA + Camrelizumab+TKI

DRUG

XELOX + QL1706+TKI

DRUG

XELOX + Tislelizumab+TKI

DRUG

Contacts

Peng Wang, MD

CONTACT

8621-64041990 peng_wang@fudan.edu.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 21, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Platform Trial for Personalized and Adaptive Therapies in Hepatocellular Carcinoma

Inclusion Criteria

Exclusion Criteria

Camrelizumab and Apatinib With or Without FOLFOX Chemotherapy for Advanced HCC

Hepatocellular Carcinoma Identification Using Delta-HLD

HAIC Combined with Donafenib and Sintilimab As Perioperative Treatment for Resectable Hepatocellular Carcinoma Patients At High Risk of Recurrence

Evaluate the Effect of Tirazamine on Primary Liver Cancer.

Ex-vivo Hypotermic Perfusion in Patients with Hepatocellular Carcinoma to Reduce the Incidence of Tumor Recurrence

First Line Hepato Cellular Carcinoma (HCC)