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

NCT06423144 | Not Yet Recruiting

• 1 other identifier: ZL-2024-06
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• OS

  Up to 48 months

• Safety

  Up to 48 months

Study Arms (2)

Group LS

Logical therapy combined with systemic therapy

Procedure: TACE/HAIC; Drug: PD-1/PD-L1 inhibits and anti-angiogenic agents

Group S

Systemic therapy alone（PD-1/PD-L1 inhibits and anti-angiogenic agents）

Drug: PD-1/PD-L1 inhibits and anti-angiogenic agents

Interventions

TACE/HAIC PROCEDURE

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

Group LS

PD-1/PD-L1 inhibits and anti-angiogenic agents DRUG

Agents were administrated based on the instructions recommended

Group LS; Group S

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with intermediate and advanced hepatocellular carcinoma beyond up to seven

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Angiogenesis Inhibitors

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)

Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Growth Inhibitors; Antineoplastic Agents; Therapeutic Uses

Central Study Contacts

Lan Zhang, MD, Ph.D

CONTACT

13918876432; zhang.lan@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 21, 2024
• Study Start: May 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: October 1, 2024
• Last Updated: May 21, 2024

Record last verified: 2024-05