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

Carcinoma, Hepatocellular Clinical Trial

Official title:

Retrospective Study and Construction of a Prediction Model for Patients With Intermediate and Advanced Liver Cancer Treated With TACE Combined With Immunotherapy and Targeted Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06205732
• Other study ID #: YXLL-KY-2023(145)
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Qianfoshan Hospital
• Contact: Jing Liang, Dr
• Phone: 0086-18663761275
• Email: liangjing0531[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

To evaluate the efficacy and safety of TACE combined with immunotherapy and targeted therapy in patients with intermediate and advanced liver cancer. Explore the factors affecting the prognosis of liver cancer treated with TACE combined with immunotherapy and targeted therapy and establish a specific individualized prognostic score and risk stratification model.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• =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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Liver Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	the Qianfoshan Hospital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qianfoshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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