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Status unknownNCT04994236Updated Aug 13, 2021

Hepatic Artery Infusion Chemotherapy for Unresectable Hepatocelluar Carcinoma Who Failed to Systemic Therapy

A Phase 2 interventional study of Hepatic artery infusion chemotherapy with FOLFOX regimens (oxaliplatin, fluorouracil, and leucovorin) in Hepatocellular Carcinoma, sponsored by Hui-Chuan Sun. Status unknown at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-08-13.

Sponsored by Hui-Chuan Sun · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
49
Allocation
Not applicable
Ages
18 Years to 90 Years
Sex
All
01

Study summary

There are limited treatment options for patients with unresectable hepatocellular carcinoma (HCC) who failed to the combination therapy with targeted agents plus anti-PD-1/PD-L1. Hepatic artery infusion chemotherapy (HAIC) had shown potent antitumor effects in single-centered studies when was used as first-line therapy. However, HAIC was not used as second or third-line therapy.

Read the detailed description

The combination therapy of anti-angiogenic agents and anti-PD-1/PD-L1 antibodies had shown potent anti-tumor efficacy for unresectable or advanced hepatocellular carcinoma. However, the treatment options were limited when patients were failed the combination therapies. Hepatic artery infusion chemotherapy (HAIC) had shown potent anti-tumor efficacy with an acceptable safety profile as a first-line treatment for patients with intermediated-stage or advanced-stage hepatocellular carcinoma. In this study, the investigators aimed to evaluate the efficacy and safety of HAIC were used in the late-line setting, i.e., after the failure of combination therapy with anti-angiogenic agents and anti-PD-1/PD-L1 antibodies.

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Conditions studied

  • Hepatocellular Carcinoma

Keywords

  • Hepatic artery infusion chemotherapy
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 49 is close to the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Hui-Chuan Sun is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Hepatocellular carcinoma diagnosed histologically/cytologically, or meeting the clinical diagnostic criteria of the "Guidelines for the Diagnosis and Treatment of Hepatocellular Carcinoma (2019 Edition)."
  • Unresectable or advanced hepatocellular carcinoma that was assessed by the investigator. Advanced hepatocellular carcinoma was defined as BCLC C stage or Chinese Liver Cancer stage (CNLC) IIIa or IIIb stage.
  • Had at least one measurable lesion in the liver.
  • Liver function Child-Pugh classification of A or B7.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Patients who have received combination therapy with targeted agents combined with immune checkpoint inhibitors and have developed intolerable adverse effects or imaging confirmed intrahepatic tumor progression and have signed an informed consent form. Targeted agents include sorafenib, lenvatinib, donafenib, regorafenib, apatinib, bevacizumab (or biosimilar), and anlotinib; immune checkpoint inhibitors (mainly PD-1/PD-L1 antibodies) include pembrolizumab, nivolumab, camrelizumab, sintilimab, toripalimab, atezolizumab, and tislelizumab. Additional eligible subjects: subjects who have received at least one HAIC treatment were entered into safety evaluation (SAS); subjects who have received at least one imaging evaluation after treatment were entered into effectiveness evaluation (ITT).

  • Adequate bone marrow and organ function. Reassessment of bone marrow and organ function as described above is required prior to each HAIC treatment.

    • Leukocytes ≥ 3 x 10\^9/L within the last 14 days.
    • Platelets ≥ 50×10\^9/L in the last 14 days without transfusion.
    • hemoglobin ≥ 90 g/L in the last 14 days without blood transfusion or erythropoietin administration.
    • total bilirubin ≤ 2 x the upper limit of normal (ULN)
    • albumin ≥ 30 g/L in the absence of human albumin or plasma transfusion within the last 14 days
    • AST and ALT ≤ 3 x ULN.
    • serum creatinine at ≤1.5×ULN.
    • International Normalized Ratio (INR) of prothrombin time ≤ 1.5×ULN.
    • Serum HBV DNA \< 2 x 10\^3 IU/mL; for HBV DNA > 2 x 10\^3 IU/mL, treatment with nucleoside analogs for at least 1 week.
  • Without grade 3 or higher adverse events (NCI CTCAE 4.0 criteria) induced by previous systemic therapy, or grade 3 or higher events reactions have recovered to grade 2 or lower.

Exclusion criteria

Exclusion Criteria:

  • Pathologic diagnosed with mixed liver cancer, fibrous lamellar cell carcinoma or other non-hepatocellular malignancy component.
  • Previous or concurrent other malignancies, except adequately treated non-melanotic skin cancer, carcinoma in situ of the cervix, and papillary thyroid cancer
  • History of organ transplantation or hepatic encephalopathy.
  • Hypersensitivity to iodine-containing contrast agents, oxaliplatin, calcium folinic acid, and fluorouracil.
  • History of gastrointestinal perforation and/or fistula within 6 months, history of intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection complicated by chronic diarrhea), Crohn's disease, ulcerative colitis, or long-term chronic diarrhea.
  • Uncontrollable hypertension, systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg after optimal medical therapy, history of hypertensive crisis or hypertensive encephalopathy.
  • Gastrointestinal bleeding due to portal hypertension within 6 months; G3 varices by gastrointestinal endoscopy within 3 months.
  • Subjects requesting withdrawal of informed consent.
  • Other circumstances that the investigator deems inappropriate for participation in the clinical trial.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
49 participants (estimated)

Study arms

  • Experimental
    Hepatic Artery Infusion Chemotherapy

    Subjects assigned to this arm will receive chemotherapy via catheterizations placed into the hepatic artery.

    Drug: Hepatic artery infusion chemotherapy with FOLFOX regimens (oxaliplatin, fluorouracil, and leucovorin)

Interventions

  • DrugHepatic artery infusion chemotherapy with FOLFOX regimens (oxaliplatin, fluorouracil, and leucovorin)

    The FOLFOX regiments were given via hepatic artery catheterization, including oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, fluorouracil bolus 400 mg/m2, followed by fluorouracil infusion 2400 mg/m2 for 46 hours. If no severe adverse events occurred, the treatment will be repeated every 3 weeks.

    Also known as: HAIC

06

What researchers measure

Primary outcomes

  1. Objective response of intrahepatic lesions

    Subjects with complete response or partial response assessed by RECIST v1.1 criteria.

    Time frame: up to 1 year

Secondary outcomes

  1. duration of response of intrahepatic lesions

    the interval between the time of partial or complete response to the time of progressive disease in intrahepatic lesions.

    Time frame: up to 1 year

  2. Progression free survival

    the interval between the time of first HAIC treatment to the time of progressive disease or patient death

    Time frame: up to 1 year

  3. Overall survival

    the interval between the time of first HAIC treatment initiation to the time of patient death

    Time frame: up to 2 year

  4. Treatment cycles of HAIC

    the total cycles of HAIC treatments, when the subjects could not tolerate HAIC or lose the benefit from HAIC treatment, HAIC will be discontinued.

    Time frame: up to 1 year

  5. Ratio of R0 resection

    The ratio of subjects who underwent R0 resection to subjects received who received at least 1 cycle of HAIC.

    Time frame: up to 1 year

  6. The rate of adverse events

    Nature, incidence, severity and seriousness of the adverse events. Adverse events are graded according to the NCI-CTCAE (Version 5.0)

    Time frame: up to 1 year

07

Study locations

1 of 1 sites recruiting
  • Zhongshan Hospital
    Shanghai, Shanghai 200032, China
    Recruiting
08

References and documents

Publications

  • He MK, Liang RB, Zhao Y, Xu YJ, Chen HW, Zhou YM, Lai ZC, Xu L, Wei W, Zhang YJ, Chen MS, Guo RP, Li QJ, Shi M. Lenvatinib, toripalimab, plus hepatic arterial infusion chemotherapy versus lenvatinib alone for advanced hepatocellular carcinoma. Ther Adv Med Oncol. 2021 Mar 25;13:17588359211002720. doi: 10.1177/17588359211002720. eCollection 2021. PubMed 33854567 ↗
  • Zhou J, Sun H, Wang Z, Cong W, Wang J, Zeng M, Zhou W, Bie P, Liu L, Wen T, Han G, Wang M, Liu R, Lu L, Ren Z, Chen M, Zeng Z, Liang P, Liang C, Chen M, Yan F, Wang W, Ji Y, Yun J, Cai D, Chen Y, Cheng W, Cheng S, Dai C, Guo W, Hua B, Huang X, Jia W, Li Y, Li Y, Liang J, Liu T, Lv G, Mao Y, Peng T, Ren W, Shi H, Shi G, Tao K, Wang W, Wang X, Wang Z, Xiang B, Xing B, Xu J, Yang J, Yang J, Yang Y, Yang Y, Ye S, Yin Z, Zhang B, Zhang B, Zhang L, Zhang S, Zhang T, Zhao Y, Zheng H, Zhu J, Zhu K, Liu R, Shi Y, Xiao Y, Dai Z, Teng G, Cai J, Wang W, Cai X, Li Q, Shen F, Qin S, Dong J, Fan J. Guidelines for the Diagnosis and Treatment of Hepatocellular Carcinoma (2019 Edition). Liver Cancer. 2020 Dec;9(6):682-720. doi: 10.1159/000509424. Epub 2020 Nov 11. PubMed 33442540 ↗
  • Finn RS, Ikeda M, Zhu AX, Sung MW, Baron AD, Kudo M, Okusaka T, Kobayashi M, Kumada H, Kaneko S, Pracht M, Mamontov K, Meyer T, Kubota T, Dutcus CE, Saito K, Siegel AB, Dubrovsky L, Mody K, Llovet JM. Phase Ib Study of Lenvatinib Plus Pembrolizumab in Patients With Unresectable Hepatocellular Carcinoma. J Clin Oncol. 2020 Sep 10;38(26):2960-2970. doi: 10.1200/JCO.20.00808. Epub 2020 Jul 27. PubMed 32716739 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04994236
Lead sponsor
Hui-Chuan Sun
Responsible party
Hui-Chuan Sun (Professor of Surgery, Shanghai Zhongshan Hospital) — Sponsor-investigator
First posted
Aug 6, 2021
Start date
Jul 1, 2021
Primary completion
Aug 31, 2022 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
Aug 13, 2021

Study contacts

Hui-Chuan Sun, MD&PhD
Contact
sun.huichuan@zs-hospital.sh.cn
+86-21-64037181
Hui-Chuan Sun, MD&PhD
principal investigator · Fudan University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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