PD-1/PD-L1 Inhibitors and Anti-angiogenic Therapy Combined With/Without TACE/HAIC in Patients With BCLC B/C Hepatocellular Carcinoma Beyond Up-to-7

Hepatocellular Carcinoma Clinical Trial

Official title:

A Retrospective Study Comparing Interventional Therapy (TACE/HAIC) Combined With PD-1/PD-L1 Inhibitors and Anti-angiogenic Agents Versus PD-1/PD-L1 Inhibitors and Anti-angiogenic Agents Alone in the First-line Treatment of Intermediate and Advanced Hepatocellular Carcinoma Beyond up to Seven

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06423144
• Other study ID #: ZL-2024-06
• Status: Not yet recruiting
• Start date: May 2024
• Est. completion date: October 2024

Study information

• Verified date: May 2024
• Source: Shanghai Zhongshan Hospital
• Contact: Lan Zhang, MD, Ph.D
• Phone: 13918876432
• Email: zhang.lan[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a retrospective study that retrospectively included patients with intermediate and advanced HCC beyond up to seven who received first-line treatment with PD-1/PD-L1 inhibitors and anti-angiogenic agents combined with/without TACE/HAIC from January 01, 2019 to December 31, 2023 in the Department of Hepatic Oncology and Department of Liver Cancer Surgery, Zhongshan Hospital, Fudan University.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: October 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patients who have been diagnosed with advanced hepatocarcinoma (HCC), confirmed histologically or clinically.

• Patients with Barcelona (BCLC) stage B and C beyond up to seven;

• Have not received any prior systemic therapy for HCC (including: chemotherapy, molecular targeted therapy, immunotherapy);

• Receiving only post-marketing PD-1/PD-L1 inhibitors in combination with anti-angiogenic agents (including, but not limited to, drugs containing hepatocellular carcinoma indications);

*The interval between the first use of PD-1/PD-L 1 inhibitors and the use of anti-angiogenic drugs is = 1 week

• TACE was performed within 1 month prior/after the first PD-1/PD-L 1 inhibitor/antiangiogenic drug treatment;

• TACE treatment followed by at least 1 cycle of combination therapy, including: cTACE and DEB-TACE;

• There is at least 1 measurable lesion in the liver according to RECIST v1.1 criteria

Exclusion Criteria:

• Cholangiocellular carcinoma, mixed hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or hepatic fibrous laminar carcinoma that has been pathologically/histologically confirmed;

• Patients who do not meet the above definition of combination therapy;

• Patients had malignant tumors other than HCC within 5 years prior to enrollment (except cured limited tumors, including cervical carcinoma in situ, basal cell carcinoma of the skin, and prostate carcinoma in situ)

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Procedure:
• TACE/HAIC
TACE/HAIC were performed within 1 month prior/after the first PD-1/PD-L 1 inhibitor/antiangiogenic drug treatment;

Drug:
• PD-1/PD-L1 inhibits and anti-angiogenic agents
Agents were administrated based on the instructions recommended

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	The time from the beginning of treatment to the time of tumor progression or death from any cause (according to mRECIST and RECIST v1.1)	Up to 48 months
Primary	ORR	The percentage of patients who have best overall response of complete response (CR) or partial response (PR) according to mRECIST and RECIST v1.1	Up to 48 months
Secondary	OS	OS was defined as the interval from the date of the initial administration of any drug/procedure to death from any cause.	Up to 48 months
Secondary	Safety	Safety was defined the incidence and severity of adverse events (AEs) and serious adverse events (SAEs). The severity of AEs were evaluated based on the National Cancer Institute Common Terminology Criteria for Adverse Events version (NCI-CTCAE) v5.0.	Up to 48 months