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To predict the efficacy of tislelizumab in patients with advanced hepatocellular carcinoma based on microfluidic PDOTS model

To predict the efficacy of tislelizumab in patients with advanced hepatocellular carcinoma based on microfluidic PDOTS model

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500107934
Enrollment
Unknown
Registered
2025-08-21
Start date
2025-03-30
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular carcinoma

Interventions

Observation group:None

Sponsors

Affiliated Hospital of Nantong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.The subjects voluntarily joined this study and signed the informed consent form. 2.Age ranging from 18 to 75 years old, gender not limited; 3.Patients with clinically diagnosed hepatocellular carcinoma and those with hepatocellular carcinoma pathologically confirmed by puncture biopsy (the clinical diagnosis of hepatocellular carcinoma is based on the "Diagnosis and Treatment Guidelines for Primary Liver Cancer 2024"), with CNLC stage II or III or BCLC stage B or C; 4.Patients with ECOG-PS scores of 0-2, no severe autoimmune diseases, severe comorbidities or other contraindications to immunotherapy; 5.Imaging can evaluate the lesion. According to the efficacy evaluation criteria for Solid Tumors (RECIST version 1.1), there is at least one single-diameter measurable lesion.

Exclusion criteria

Exclusion criteria: 1.There are other malignant diseases requiring systematic treatment (except for cured basal cell carcinoma of the skin or carcinoma in situ of the cervix). 2.Have a history of other malignant tumors within the past 6 months (except as above) 3.Severe autoimmune diseases or the need for long-term use of immunosuppressants 4.Difficult-to-control infections (body temperature >=38? or uncontrolled infectious diseases) 5.Severe systemic diseases (such as uncontrolled heart disease, diabetes) 6.Pathological tissues could not be obtained or the construction of the PDOTS model failed 7.Have received PD-1/PD-L1 antibody treatment (including tislelizumab) previously 8.Allergic to tislelizumab or the ingredients of the investigational drug 9.Pregnant or lactating women 10.Uncontrollable mental illness affects compliance.

Design outcomes

Primary

MeasureTime frame
Organoid killing index;Objective Response Rate;

Secondary

MeasureTime frame
Overall survival;Progression free survival;

Countries

China

Contacts

Public ContactZhong Chen

Affiliated Hospital of Nantong University

chenz9806@163.com+86 189 6206 5077

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026