HAIC in Combination with Immune Checkpoint Inhibitors and... | NCT06632106

In Which Tumor Burden Range Does Advanced Hepatocellular Carcinoma Patients Benefit More from Hepatic Arterial Infusion Chemotherapy Plus Immune Checkpoint Inhibitors and Tyrosine Kinase Inhibitors Than Immune Checkpoint Inhibitors Plus Tyrosine Kinase Inhibitors? a Multi-center, Retrospective, Propensity Score Matching Study

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 16, 2024Actual

Primary Completion Date

Jan 30, 2025Estimated

Completion Date

May 30, 2025Estimated

First Submitted Date

Oct 6, 2024

First Submission Date that Met QC Criteria

Oct 6, 2024

First Posted Date

Oct 8, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 6, 2024

Last Update Posted Date

Oct 8, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of hepatic arterial infusion chemotherapy (HAIC) in combination with PD-1 inhibitors and Lenvatinib in patients with different tumor burden advanced-stage hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

97Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HAIC plus TKIs and ICIs		Each patient should receive at least 2 cycles of HAIC and 1cycles of TKIs plus ICIs. The interval between HAIC and TKIs plus ICIs should be within 2 weeks.	Procedure: hepatic artery infusion chemotherapy Drug: Tyrosine kinase inhibitor (TKIs) Drug: Immune Checkpoint Inhibitors
TKIs plus ICIs		Each patient should receive at least 2 cycles of ICIs. The interval between TKIs and ICIs should be within 2 weeks.	Drug: Tyrosine kinase inhibitor (TKIs) Drug: Immune Checkpoint Inhibitors

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hepatic artery infusion chemotherapy	Procedure	Hepatic arterial infusion chemotherapy including FOLFOX and RALOX	HAIC plus TKIs and ICIs

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival (OS)	The OS is defined as the time from the initiation of any combination treatment to death due to any cause.	Up to approximately 2 years

Secondary Outcomes

Measure	Description	Time Frame
Progression free survival(PFS)	The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease (according to RECIST1.1) or death due to any cause, whichever occurs first.	Up to approximately 2 years
Objective response rate(ORR) per RESCIST 1.1

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
Barcelona Clinic Liver Cancer (BCLC) stage C with the presence of portal vein tumor thrombus;
Has not received any previous systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy);
Both TKIs and ICIs patients received only include marketed drugs but are not limited to HCC approval;
HAIC was performed after the first TKIs/ ICIs treatment or before treatment;
Received at least 2 cycles of HAIC or ICIs treatments；
Has repeated measurable intrahepatic lesions;
Child-Pugh class A or B.

Exclusion Criteria:

Patients who took systemic anti-tumor treatments before the combination therapy;
With other malignant tumors;
Unable to meet criteria of combination timeframe described above.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with advanced HCC with PVTT who received HAIC in combination with TKIs and ICIs under real-world practice conditions.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The first hospital of China medical university		Shenyang	Liaoning	110000	China

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008113	Liver Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D004066	Digestive System Diseases
D008107	Liver Diseases

ID	Term
D047428	Protein Kinase Inhibitors
D004791	Enzyme Inhibitors
D045504	Molecular Mechanisms of Pharmacological Action
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses
D000074322	Antineoplastic Agents, Immunological
D000970	Antineoplastic Agents
D045506	Therapeutic Uses

ID	Term
D000092004	Tyrosine Kinase Inhibitors
D000082082	Immune Checkpoint Inhibitors