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HAIC Combined With Bevacizumab and Toripalimab for Advanced Hepatocellular Carcinama

NCT ID: NCT04627363

Last Updated: 2020-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2023-06-30

Brief Summary

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This is an open-label, single-arm clinical study to preliminarily observe and evaluate the efficacy and safety of hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin synchronous combined with Bevacizumab and Toripalimab as the first-line therapy for advanced HCC.

Detailed Description

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Hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin was effective and safe for hepatocellular carcinoma. Bevacizumab, an angiogenesis Inhibitors was effectively used for hepatocelluar carcinama (HCC) therapy. Toripalimab, an programmed cell death protein-1 (PD-1) antibody, was effective and tolerable in patients with hepatocellular carcinoma and portal vein tumor thrombus. No study has evaluated HAIC plus Bevacizumab and Toripalimab. Thus, the investigators carried out this prospective, single-arm study to find out it.

Conditions

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Hepatocellular Carcinoma Bevacizumab Liver Neoplasms Toripalimab Oxaliplatin

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HAIC plus Bevacizumab and Toripalimab

Hepatic arterial infusion of oxaliplatin , fluorouracil, and leucovorin every 6 weeks. Lenvatinib 12 mg (or 8 mg) once daily (QD) oral dosing. Toripalimab, 240 mg intravenously every 3 weeks. Bevacizumab 15 mg/kg intravenously every 3 weeks.

Group Type EXPERIMENTAL

Hepatic arterial infusion chemotherapy

Intervention Type PROCEDURE

administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 6 weeks

Bevacizumab

Intervention Type DRUG

15mg/kg intravenously every 3 weeks

Toripalimab

Intervention Type DRUG

240mg intravenously every 3 weeks

Interventions

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Hepatic arterial infusion chemotherapy

administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 6 weeks

Intervention Type PROCEDURE

Bevacizumab

15mg/kg intravenously every 3 weeks

Intervention Type DRUG

Toripalimab

240mg intravenously every 3 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. HCC diagnosed by histopathological examination or Guidelines for Diagnosis and Treatment of Primary Liver Cancer or the recurrent HCC after surgery;
2. age between 18 and 75 years;
3. Stage B (middle stage) or C (late stage) HCC determined in accordance with Barcelona Clinic Liver Cancer staging system (BCLC stage). In case of stage B.
4. No previous use of any systemic therapy or recurrent HCC.
5. Child-Pugh class A or B;
6. Eastern Cooperative Group performance status (ECOG) score of 0-2;
7. 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
8. Prothrombin time ≤18s or international normalized ratio \< 1.7.
9. Ability to understand the protocol and to agree to and sign a written informed consent document.

Exclusion Criteria

1. Cholangiocellular carcinoma (ICC);
2. Patients with cancer thrombus in the main trunk of portal vein (Vp4), or cancer thrombus in inferior vena cava should be excluded;
3. Accepting ablation or surgery or other system therapy as firt line therapy after diagnose for primary HCC, ablation or system therapy as first line therapy for recurrent HCC.
4. Serious medical comorbidities.
5. Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
6. Known history of HIV
7. History of organ allograft
8. Known or suspected allergy to the investigational agents or any agent given in association with this trial.
9. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
10. Evidence of bleeding diathesis.
11. Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role collaborator

Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Zhou Qunfang

Clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fei Gao

Role: STUDY_DIRECTOR

Sun Yat-sen University

Kangshun Zhu, Professor

Role: STUDY_DIRECTOR

Second Affiliated Hospital of Guangzhou Medical University

Central Contacts

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Qunfnag Zhou, MD

Role: CONTACT

Phone: 86 19868000115

Email: [email protected]

Fei Gao, Professor

Role: CONTACT

Email: [email protected]

Other Identifiers

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GYEYJR-3

Identifier Type: -

Identifier Source: org_study_id