NCT03780049 is a Phase 3 clinical trial of HAIC of FOLFOX in Hepatocellular Carcinoma, sponsored by Sun Yat-sen University.

Who is sponsoring NCT03780049?

NCT03780049 is sponsored by Sun Yat-sen University.

What drugs are being tested in NCT03780049?

Interventions in NCT03780049: HAIC of FOLFOX, H101, Placebos.

What condition does NCT03780049 study?

NCT03780049 studies Hepatocellular Carcinoma.

Is NCT03780049 still recruiting?

NCT03780049 is currently status unknown. Last updated 21 May 2020.

Last reviewed 2020-05-21 · How we verify

NCT03780049

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

HAIC Plus H101 vs HAIC Alone for Unresectable HCC at BCLC A-B

Status unknown Phase 3 Last updated 21 May 2020

What this trial tests

Phase 3 trial testing HAIC of FOLFOX in Hepatocellular Carcinoma in 304 participants. Status unknown.

Timeline

1 October 2018

Primary endpoint
1 October 2023

1 October 2023

Quick facts

Lead sponsor	Sun Yat-sen University
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	304
Start date	1 October 2018
Primary completion	1 October 2023
Estimated completion	1 October 2023
Sites	1 location across China

Drugs / interventions tested

HAIC of FOLFOX — full drug profile →
H101 — full drug profile →
Placebos — full drug profile →

Conditions studied

Hepatocellular Carcinoma — all drugs for Hepatocellular Carcinoma →

Sponsor

Sun Yat-sen University

Who can join

Adults 18 to 75, any sex, with Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Hepatic artery infusion chemotherapy (HAIC) is effective and safe for hepatocellular carcinoma (HCC). Recombinant Human Type-5 Adenovirus (H101) is safe for HCC. The purpose of this study is to evaluate the efficacy and safety of HAIC combined with H101 compared with HAIC alone in patients with unresectable hepatocellular carcinoma (HCC) at barcelona clinic liver cancer A-B stage.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Intratumoral microbiota: roles in cancer initiation, development and therapeutic efficacy.
Yang L, Li A, Wang Y, Zhang Y. · · 2023 · cited 299× · PMID 36646684 · DOI 10.1038/s41392-022-01304-4
Viral vector-based gene therapies in the clinic.
Zhao Z, Anselmo AC, Mitragotri S. · · 2022 · cited 171× · PMID 35079633 · DOI 10.1002/btm2.10258
Oncolytic viruses encoding bispecific T cell engagers: a blueprint for emerging immunovirotherapies.
Heidbuechel JPW, Engeland CE. · · 2021 · cited 80× · PMID 33863363 · DOI 10.1186/s13045-021-01075-5
Concepts in Oncolytic Adenovirus Therapy.
Mantwill K, Klein FG, Wang D, Hindupur SV, et al · · 2021 · cited 75× · PMID 34638863 · DOI 10.3390/ijms221910522
Immunology of Adenoviral Vectors in Cancer Therapy.
Shaw AR, Suzuki M. · · 2019 · cited 62× · PMID 31890734 · DOI 10.1016/j.omtm.2019.11.001
Clinical CAR-T Cell and Oncolytic Virotherapy for Cancer Treatment.
Watanabe N, McKenna MK, Rosewell Shaw A, Suzuki M. · · 2021 · cited 60× · PMID 33130314 · DOI 10.1016/j.ymthe.2020.10.023
Preclinical And Clinical Development Of Oncolytic Adenovirus For The Treatment Of Malignant Glioma.
Kiyokawa J, Wakimoto H. · · 2019 · cited 58× · PMID 31750274 · DOI 10.2147/ov.s196403
Current Status of Gene Therapy in Hepatocellular Carcinoma.
Reghupaty SC, Sarkar D. · · 2019 · cited 47× · PMID 31466358 · DOI 10.3390/cancers11091265

Verify or expand the search:

Other trials of HAIC of FOLFOX

Trials testing the same drug.

NCT07012798 — FOLFOX Combined With Durvalumab (MEDI4736), Bevacizumab, and Stereotactic Body Radiotherapy in Sequential Treatment of P · Phase 2 · not yet recruiting
NCT05124002 — Recombinant Human Adenovirus Type 5 Plus HAIC of FOLFOX for Intrahepatic Cholangiocarcinoma · Phase 4 · unknown
NCT03812770 — Phase 2 Study of Sorafenib Plus HAIC of FOLFOX vs. Sorafenib Plus HAIC of OXA for Advanced HCC · Phase 2 · unknown
NCT03722498 — Phase Ⅱ Study of HAIC of FOLFOX vs. Sorafenib in HCC Refractory to TACE · Phase 2 · withdrawn
NCT03468231 — HAIC of FOLFOX vs. HAIC of OXA for Advanced HCC · Phase 3 · unknown

Other recruiting trials for Hepatocellular Carcinoma

Currently open trials in the same condition.

NCT06902246 — Regorafenib and Yttrium-90 Radioembolization for Unresectable Hepatocellular Carcinoma · Phase 2 · recruiting
NCT05842174 — Targeting Ischemia-Induced Autophagy Dependence in Hepatocellular Carcinoma · Phase 1, PHASE2 · recruiting
NCT07417397 — Adjuvant TACE in HCC With High-risk Recurrence Factors · Phase 3 · recruiting
NCT07317414 — β-alanine in the Treatment of Advanced Hepatocellular Carcinoma · Phase 2 · recruiting
NCT07148050 — Immunotherapy for Solid Tumor Malignancies in Pediatrics Using Interleukin-15 and -21 Armored Glypican-3-specific Chimer · Phase 1 · recruiting

Other Sun Yat-sen University trials

Trials by the same sponsor.

NCT07255612 — Bone Marrow Protection, Safety, Efficacy of Trilaciclib and Eribulin in Locally Advanced or Metastatic TNBC(Triple-negat · Phase 2 · not yet recruiting
NCT07371897 — Toripalimab ± Chemo as Neoadjuvant Therapy in LA-HNSCC: A Phase III Trial · Phase 3 · not yet recruiting
NCT07489703 — SHR-A1811 + AK112 in HER2-Altered Advanced/Metastatic NSCLC · Phase 2 · not yet recruiting
NCT07528209 — Neoadjuvant CAPOX With or Without Pucotenlimab Plus Selective Radiotherapy for Locally Advanced Rectal Cancer · Phase 3 · recruiting
NCT07522281 — Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI Cycles · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03780049 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sun Yat-sen University
Last refreshed: 21 May 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03780049.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing