## Protocol Section
### Identification Module
**NCT ID:** NCT06435013

**Brief Title:** Lenvatinib vs Bevacizumab Plus ICIs and HAIC in Unresectable HCC

**Official Title:** Lenvatinib Versus Bevacizumab Combined With Immune Checkpoint Inhibitors and Hepatic Arterial Infusion Chemotherapy in Unresectable Hepatocellular Carcinoma: A Retrospective, Multi-center, and Propensity Score Matching Study

#### Organization Study ID Info
**ID:** LenBev-001
#### Organization
**Class:** OTHER
**Full Name:** Sun Yat-sen University
### Status Module
#### Completion Date
**Date:** 2024-05-20

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-24

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-03-01

**Type:** ACTUAL

#### Start Date
**Date:** 2023-12-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Sun Yat-sen University

#### Responsible Party

**Investigator Affiliation:** Sun Yat-sen University

**Investigator Full Name:** Shi Ming

**Investigator Title:** Ming Shi

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Previous studies had suggested hepatic arterial infusion chemotherapy (HAIC) combined with immune checkpoint inhibitors (ICIs) and anti-angiogenic drugs had promising anti-tumor activity in unresectable hepatocellular carcinoma (HCC). Two kinds of anti-angiogenic drugs (tyrosine kinase inhibitors \[lenvatinib\] and anti-VEGF antibody \[bevacizumab\]) were applied in first-line treatment of unresectable HCC. However, little is known about the difference of efficacy and safety between lenvatinib (LenHAP) or bevacizumab (BevHAP) combined with ICIs and HAIC in unresectable HCC.

### Conditions Module

**Conditions:**

- Hepatocellular Carcinoma

- Lenvatinib

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 208

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Lenvatinib combined with hepatic arterial infusion chemotherapy and PD-1/PD-L1;

**Intervention Names:**

- Drug: Lenvatinib

**Label:** LenHAP

#### Arm Group 2

**Description:** Bevacizumab combined with hepatic arterial infusion chemotherapy and PD-1/PD-L1;

**Label:** BevHAP

### Interventions

#### Intervention 1

**Arm Group Labels:**

- LenHAP

**Description:** Lenvatinib combined with hepatic arterial infusion chemotherapy and PD-1/PD-L1;

**Name:** Lenvatinib

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** progression-free survival

**Time Frame:** 2015-1 to 2023-4

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:patients aged 18 years or older, with unresectable, locally advanced, or metastatic HCC, with the diagnosis confirmed by histologic or cytologic analysis or clinical features according to the American Association for the Study of Liver Disease criteria(15), who had received no previous treatment, had at least on measurable disease, as defined by Response Evaluation Criteria In Solid Tumours version 1.1 (RECIST v1.1) criteria(16), had a baseline Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, had a Child-Pugh liver function score of 7 or less and had adequate hematologic and organ function (absolute neutrophil count ≥1.2×109/l, platelet count ≥60×109/l, total bilirubin \<30μmol/l, albumin ≥30g/l, aspartate transaminase and alanine transaminase ≤5×upper limit of the normal, creatinine clearance rate of ≤1.5×upper limit of the normal, and left ventricular ejection ≥45%) -

Exclusion Criteria:history of HIV, organ allograft, combined with other malignant tumors, evidence of hepatic decompensation, bleeding diathesis or event, and allergy to the investigational agents or any agent given in association with this trial and incomplete medical information.

-

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** patients with received the combination therapy of lenvatinib/bevacizumab, hepatic arterial infusion chemotherapy and PD-1/L1

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Guangzhou

**Country:** China

**Facility:** Cancer Center Sun Yat-sen University

**State:** Guangdong

**Zip:** 510060

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000000230

- Term: Adenocarcinoma

- ID: D000008113

- Term: Liver Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000008107

- Term: Liver Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BC06

- Name: Digestive System Diseases

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: HIGH

- As Found: Carcinoma

- ID: M9613

- Name: Carcinoma, Hepatocellular

- Relevance: HIGH

- As Found: Hepatocellular Carcinoma

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M3585

- Name: Adenocarcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M11113

- Name: Liver Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11107

- Name: Liver Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002277

- Term: Carcinoma

- ID: D000006528

- Term: Carcinoma, Hepatocellular

### Intervention Browse Module - Ancestors

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000047428

- Term: Protein Kinase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M353738

- Name: Lenvatinib

- Relevance: HIGH

- As Found: Primary care

- ID: M246

- Name: Bevacizumab

- Relevance: LOW

- As Found: Unknown

- ID: M2342

- Name: Immune Checkpoint Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M25820

- Name: Protein Kinase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000531958

- Term: Lenvatinib

### Misc Info Module

- Version Holder: 2024-05-31
