---
title: HAIC Plus PD-1 Antibody vs HAIC Plus Sorafenib for Advanced HCC
nct_id: NCT03780634
overall_status: WITHDRAWN
phase: PHASE2
sponsor: Sun Yat-sen University
study_type: INTERVENTIONAL
primary_condition: Hepatocellular Carcinoma
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03780634.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03780634"
ct_last_update_post_date: 2019-05-06
last_seen_at: "2026-05-12T07:22:49.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# HAIC Plus PD-1 Antibody vs HAIC Plus Sorafenib for Advanced HCC

**Official Title:** Hepatic Artery Infusion Chemotherapy Plus Programmed Cell Death Protein-1 (PD-1) Antibody vs Hepatic Artery Infusion Chemotherapy Plus Sorafenib for Advanced Hepatocellular Carcinoma

**NCT ID:** [NCT03780634](https://clinicaltrials.gov/study/NCT03780634)

## Key Facts

- **Status:** WITHDRAWN
- **Why Stopped:** No participants enrolled
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 0
- **Lead Sponsor:** Sun Yat-sen University
- **Collaborators:** Kaiping Central Hospital, Guangzhou No.12 People's Hospital
- **Conditions:** Hepatocellular Carcinoma
- **Start Date:** 2019-04-01
- **Completion Date:** 2021-12-01
- **CT.gov Last Update:** 2019-05-06

## Brief Summary

The purpose of this study is to evaluate the efficacy and safety of hepatic artery infusion chemotherapy (HAIC) combined with Programmed Cell Death Protein-1 (PD-1) antibody compared with HAIC plus sorafenib in patients with advanced hepatocellular carcinoma (HCC)

## Detailed Description

The results of our preliminary pilot study suggested that sorafenib combined with hepatic arterial infusion chemotherapy (HAIC) may improve the survivals for advanced hepatocellular (HCC). Programmed Cell Death Protein-1 (PD-1) antibody has been proved effective and safety for advanced HCC. There is no study about HAIC plus PD-1 antibody. Thus, the investigators carried out this prospective randomized control study to compare HAIC plus sorafenib and HAIC plus PD-1 antibody.

## 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
* Major portal vein tumor thrombus (Vp3,Vp4)
* Eastern Cooperative Oncology Group performance status of 0 to 1
* 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:

  * Platelet count ≥ 75,000/μL
  * Hemoglobin ≥ 8.5 g/dL
  * Total bilirubin ≤ 30mmol/L
  * Serum albumin ≥ 30 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 PD-1 antibody** (EXPERIMENTAL) — Participants received PD-1 antibody intravenously and hepatic artery infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin every 3 weeks up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
- **HAIC plus sorafenib** (ACTIVE_COMPARATOR) — Participants received sorafenib capsules 400mg bid in continuous 21-day treatment cycles, and received hepatic artery infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin every 3 weeks up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.

## Interventions

- **HAIC** (PROCEDURE) — administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 3 weeks
- **PD-1 antibody** (DRUG) — 200mg intravenously every 3 weeks
- **Sorafenib** (DRUG) — 400 mg Bid Po

## Primary Outcomes

- **Progression Free Survival (PFS)** _(time frame: 12 months)_ — PFS was defined as the time from the date of randomization to the date of first documentation of disease progression based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1), or date of death, whichever occurred first.

## Secondary Outcomes

- **Overall Survival (OS)** _(time frame: 12 months)_
- **Objective Response Rate (ORR)** _(time frame: 12 months)_
- **Adverse Events** _(time frame: 12 months)_

## Locations (3)

- Cancer Center Sun Yat-sen University, Guangzhou, Guangdong, China
- Guangzhou Twelfth People 's Hospital, Guangzhou, Guangdong, China
- Kaiping Central Hospital, Kaiping, Guangdong, China

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — 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)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.cancer center sun yat-sen university|guangzhou|guangdong|china` — added _(2026-05-12)_
- `locations.guangzhou twelfth people 's hospital|guangzhou|guangdong|china` — added _(2026-05-12)_
- `locations.kaiping central hospital|kaiping|guangdong|china` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03780634.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03780634*  
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