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Sequential local treatment with immune checkpoint inhibitors as the foundation for inoperable advanced-stage hepatocellular carcinoma: A prospective cohort study with escalated treatment intensity.

Sequential local treatment with immune checkpoint inhibitors as the foundation for inoperable advanced-stage hepatocellular carcinoma: A prospective cohort study with escalated treatment intensity.

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400083305
Enrollment
Unknown
Registered
2024-04-21
Start date
2024-04-21
Completion date
Unknown
Last updated
2024-04-22

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

Conditions

Hepatocellular carcinoma

Interventions

TACE group: Patients with advanced-stage liver cancer with Child-Pugh score =8 points and either irreparable or Performance Status (PS) score =2 points, who are not eligible for surgery.:The best supp
TACE+TKI+ICIs group: Patients with a Performance Status (PS) score of 0-1, Child-Pugh score =7, and inadequate response of residual lesions (residual single lesion within 5cm or multiple lesions with
TACE+RFA+TKI+ICIs group: Patients with a Performance Status (PS) score of 0-1, Child-Pugh score =7, and residual single lesion within 5cm or multiple lesions with the largest being within 3cm.:Provide

Sponsors

The First People's Hospital of Yibin
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Confirmed diagnosis of primary liver cancer by pathology or imaging, with Barcelona Clinic Liver Cancer (BCLC) stage B or above; 2) Child-Pugh score =7 points; 3) Performance Status (PS) score of 0-1; 4) Hematological examination: white blood cells =2.0×10^9/L, hemoglobin =80g/L, platelets =50×10^9/L; 5) Expected survival =12 weeks; 6) Signed informed consent form, age =18 years. (1, 5 cited from "Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2022 edition)")

Exclusion criteria

Exclusion criteria: 1) Combined with a second primary tumor; 2) Patients in pregnancy or lactation; 3) Tumor invasion of hollow visceral organs or bile duct obstruction; 4) Irreversible coagulation dysfunction; 5) Failure of important organ functions such as heart, lung, liver, and kidney; 6) Organ transplant recipients; 7) Patients with poorly controlled autoimmune diseases; 8) Allergic to any drugs used in this treatment.

Design outcomes

Primary

MeasureTime frame
Maximum lesion diameter.;Sum of the diameters of measurable target lesions.;

Countries

China

Contacts

Public ContactChen Xiaochun

The First People's Hospital of Yibin

958308044@qq.com+86 182 1567 6560

Outcome results

None listed

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