---
title: HAIC Plus Lenvatinib and Toripalimab for Advanced HCC
nct_id: NCT04044313
overall_status: COMPLETED
phase: PHASE2
sponsor: Shi Ming
study_type: INTERVENTIONAL
primary_condition: Hepatocellular Carcinoma
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04044313.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04044313"
ct_last_update_post_date: 2023-06-12
last_seen_at: "2026-05-12T06:54:55.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# HAIC Plus Lenvatinib and Toripalimab for Advanced HCC

**Official Title:** Hepatic Arterial Infusion Chemotherapy Plus Lenvatinib and Toripalimab for Advanced Hepatocellular Carcinoma： a Prospective, Single-arm Trial

**NCT ID:** [NCT04044313](https://clinicaltrials.gov/study/NCT04044313)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 36
- **Lead Sponsor:** Shi Ming
- **Conditions:** Hepatocellular Carcinoma
- **Start Date:** 2019-08-01
- **Completion Date:** 2022-02-28
- **CT.gov Last Update:** 2023-06-12

## Brief Summary

The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus lenvatinib and toripalimab in patients with advanced hepatocellular carcinoma (HCC)

## Detailed Description

Hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin was effective and safe for hepatocellular carcinoma. Lenvatinib was non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma, and programmed cell death protein-1 (PD-1) antibody was effective and tolerable in patients with advanced hepatocellular carcinoma. No study has evaluated HAIC plus lenvatinib and toripalimab. Thus, the investigators carried out this prospective, single-arm study to find out it.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
* Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria.
* Barcelona clinic liver cancer-stage C
* Eastern Cooperative Oncology Group performance status of 0 to 2
* With no previous treatment
* No Cirrhosis or cirrhotic status of Child-Pugh class A only
* Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
* The following laboratory parameters:

Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3

• Ability to understand the protocol and to agree to and sign a written informed consent document

Exclusion Criteria:

* Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
* Known history of HIV
* History of organ allograft
* Known or suspected allergy to the investigational agents or any agent given in association with this trial.
* Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
* Evidence of bleeding diathesis.
* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
* Known central nervous system tumors including metastatic brain disease
```

## Arms

- **HAIC plus Lenvatinib and Toripalimab** (EXPERIMENTAL) — Hepatic arterial infusion of oxaliplatin , fluorouracil, and leucovorin every 3 weeks. Lenvatinib 12 mg (or 8 mg) once daily (QD) oral dosing. Toripalimab 240mg intravenously every 3 weeks.

## Interventions

- **Hepatic arterial infusion chemotherapy** (PROCEDURE) — administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 3 weeks
- **Lenvatinib** (DRUG) — 12 mg (or 8 mg) once daily (QD) oral dosing.
- **Toripalimab** (DRUG) — 240mg intravenously every 3 weeks

## Primary Outcomes

- **Progression free survival rate at 6 months** _(time frame: 6 months)_ — Progression was defined as progressive disease by independent radiologic review according to RECIST or death from any cause

## Secondary Outcomes

- **Overall survival (OS)** _(time frame: 6 months)_
- **Progression free survival (PFS)** _(time frame: 6 months)_
- **Objective response rate (ORR)** _(time frame: 6 months)_
- **Adverse events** _(time frame: 6 months)_

## Locations (1)

- Cancer Center Sun Yat-sen University, Guangzhou, Guangdong, China

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.cancer center sun yat-sen university|guangzhou|guangdong|china` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04044313.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04044313*  
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