A Retrospective Study on the Treatment of Intermediate and Advanced Liver Cancer.

NCT06205732 | Unknown

• 1 other identifier: YXLL-KY-2023(145)
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effectiveness of TACE combined with immunotherapy and targeted therapy versus TACE alone in patients with intermediate and advanced liver cancer.

Conditions

Carcinoma, Hepatocellular

Outcome Measures

Primary Outcomes (1)

• Progression-Free-Survival

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first.

  12 months

Study Arms (2)

TACE+PD-(L)1+TKI

Application of TACE, TKI, and immunotherapy in patients with intermediate and advanced liver cancer.

Other: Immunotherapy, targeted therapy.

TACE alone

Application of TACE in patients with intermediate and advanced liver cancer.

Interventions

Immunotherapy, targeted therapy. OTHER

Immunotherapy (sintilimab, camrelizumab, tislelizumab, atezolizumab, durvalumab, cardenilumab, and pembrolizumab); targeted therapy (apatinib, lenvatinib, sorafenib, and regorafenib).

TACE+PD-(L)1+TKI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with intermediate and advanced liver cancer who received TACE combined with immunotherapy and targeted therapy.

You may qualify if:

• ≥18 years old, both men and women
• primary liver cancer confirmed by liver biopsy or history of hepatitis B, AFP, and typical imaging findings
• patients with liver function Child-Pugh A or B (≤8 points)
• BCLC stage B and stage C
• expected survival time ≥8 weeks
• patients with generally good performance status (ECOG PS score 0 or 1)

You may not qualify if:

• The patient's key data is missing
• liver metastatic cancer confirmed by histology or cytology
• patients who interrupt treatment due to intolerance of adverse drug reactions
• combined with primary malignant tumors of other organs within 5 years; combined with other serious diseases, such as severe heart disease, renal insufficiency, severe infection, bleeding, etc.
• combined with systemic infection, autoimmune disease, or other types of tumors; previous allogeneic bone marrow transplantation or solid organ transplantation
• study participants known to have mental illness
• situations such as drug use or substance abuse

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (1)

the Qianfoshan Hospital

Jinan, Shandong, 250000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Patient's admission medical records, laboratory tests, etc.

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Immunotherapy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics

Study Officials

• Jing Liang, Dr

  the Qianfoshan Hospital

  STUDY DIRECTOR

Central Study Contacts

Jing Liang, Dr

CONTACT

0086-18663761275; liangjing0531@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 16, 2024
• Study Start: January 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 16, 2024

Record last verified: 2024-01

Locations

CN (1)