Application of Integrated Proteomic and Serum Metabolomic Analysis in Assessing the Efficacy and Prognosis of TACE Combined With Targeted Immunotherapy in Unresectable Hepatocellular Carcinoma

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Invitation-only

Conditions: Hepatocellular Carcinoma

Study type: Observational

Funder types: Other

Identifiers

NCT06540508

NCC3651

Details and patient eligibility

About

Application of Integrated Proteomic and Serum Metabolomic Analysis in Efficacy and Prognosis Assessment: A multi-omics analysis based on gut microbiota to evaluate the predictive value of microbial-derived proteins and metabolites on treatment efficacy and patient outcomes, developing non-invasive tools for treatment monitoring and prognostic prediction.

Full description

This study is a prospective, observational study based on real-world data. It prospectively and continuously collects data from patients with unresectable hepatocellular carcinoma who have received TACE combined with targeted and immunotherapy as part of their routine diagnostic and treatment procedures. Patients are grouped based on treatment efficacy, and integrated proteomic and serum metabolomic analyses are conducted on samples before and during treatment to obtain clinical evidence from the real world.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years.
• Histologically or clinically diagnosed with hepatocellular carcinoma (HCC).
• Classified as BCLC stage B/C, not suitable for surgical resection or liver transplantation.
• Planned or already receiving TACE combined with tiragolumab and first-line targeted therapy for liver cancer.
• Not participating in other clinical studies.
• Able to obtain imaging evaluation data and other clinical records during treatment.

Exclusion criteria

• Known fibrolamellar HCC, sarcomatoid HCC, or mixed hepatocellular-cholangiocarcinoma histology.
• Tumors involving the main portal vein or inferior vena cava.
• Use of antibiotics within one month before treatment.
• History of other malignancies.

Trial design

30 participants in 2 patient groups

Observation group 1

Description:

Patients considered to have effective treatment after TACE combined with targeted immunotherapy, as assessed by mRECIST.

Observation group 2

Description:

Patients considered to have ineffective treatment after TACE combined with targeted immunotherapy, as assessed by mRECIST.