NCT04042805 is a Phase 2 clinical trial of Sintilimab in Hepatocellular Carcinoma, sponsored by Baocai Xing.

Who is sponsoring NCT04042805?

NCT04042805 is sponsored by Baocai Xing.

What drugs are being tested in NCT04042805?

Interventions in NCT04042805: Sintilimab, Lenvatinib.

What condition does NCT04042805 study?

NCT04042805 studies Hepatocellular Carcinoma.

Is NCT04042805 still recruiting?

NCT04042805 is currently status unknown. Last updated 2 March 2021.

Last reviewed 2021-03-02 · How we verify

NCT04042805

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

Sintilimab Combined With Lenvatinib in Local Advanced Hepatocellular Carcinoma

Status unknown Phase 2 Last updated 2 March 2021

What this trial tests

Phase 2 trial testing Sintilimab in Hepatocellular Carcinoma in 36 participants. Status unknown.

Timeline

1 August 2019

Primary endpoint
30 August 2022

30 August 2024

Quick facts

Lead sponsor	Baocai Xing
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	36
Start date	1 August 2019
Primary completion	30 August 2022
Estimated completion	30 August 2024
Sites	1 location across China

Drugs / interventions tested

Sintilimab — full drug profile →
Lenvatinib (LENVATINIB) — full drug profile →

Conditions studied

Hepatocellular Carcinoma — all drugs for Hepatocellular Carcinoma →

Sponsor

Baocai Xing

Who can join

Adults 18 to 100, any sex, with Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This ia a single-arm, single-center, not-randomized, open-label phase II study. The purpose of this study is to evaluate the efficacy and safety of Sintilimab (PD-1 antibody) combined with Lenvatinib(TKI) for the treatment of local advanced hepatocellular carcinoma.

Publications & conference data

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

The Current Landscape of Immune Checkpoint Blockade in Hepatocellular Carcinoma: A Review.
Pinter M, Jain RK, Duda DG. · · 2021 · cited 271× · PMID 33090190 · DOI 10.1001/jamaoncol.2020.3381
Immunosuppressive tumor microenvironment and immunotherapy of hepatocellular carcinoma: current status and prospectives.
Shen KY, Zhu Y, Xie SZ, Qin LX. · · 2024 · cited 140× · PMID 38679698 · DOI 10.1186/s13045-024-01549-2
Liver Cancer Immunity.
Ilyas SI, Wang J, El-Khoueiry AB. · · 2021 · cited 81× · PMID 32516437 · DOI 10.1002/hep.31416
Therapy of Primary Liver Cancer.
Feng M, Pan Y, Kong R, Shu S. · · 2020 · cited 71× · PMID 32914142 · DOI 10.1016/j.xinn.2020.100032
Clinical outcomes and influencing factors of PD-1/PD-L1 in hepatocellular carcinoma.
Wang J, Li J, Tang G, Tian Y, et al · · 2021 · cited 41× · PMID 33732355 · DOI 10.3892/ol.2021.12540
Tumor Mutational Burden for Predicting Prognosis and Therapy Outcome of Hepatocellular Carcinoma.
Gabbia D, De Martin S. · · 2023 · cited 40× · PMID 36834851 · DOI 10.3390/ijms24043441
Advances of Targeted Therapy for Hepatocellular Carcinoma.
Niu M, Yi M, Li N, Wu K, et al · · 2021 · cited 39× · PMID 34381735 · DOI 10.3389/fonc.2021.719896
Trial Watch: combination of tyrosine kinase inhibitors (TKIs) and immunotherapy.
Petrazzuolo A, Maiuri MC, Zitvogel L, Kroemer G, et al · · 2022 · cited 23× · PMID 35655707 · DOI 10.1080/2162402x.2022.2077898

Verify or expand the search:

Other trials of Sintilimab

Trials testing the same drug.

NCT07535632 — SBRT Followed by PD-1 Inhibitor, Bevacizumab and TAS-102 as Third-Line Therapy for Recurrent/Metastatic Colorectal Cance · Phase 2 · not yet recruiting
NCT07537946 — Local Consolidation After Sintilimab Plus Lenvatinib for Metastatic Liver Cancer · Phase 3 · not yet recruiting
NCT07537972 — Denosumab Strategy for Liver Cancer With Bone Metastases · Phase 2 · not yet recruiting
NCT07468630 — Tolecizumab Plus Chemoimmunotherapy for pMMR/MSS Locally Advanced Colon Adenocarcinoma · Phase 2 · recruiting
NCT07515625 — Efficacy of Sintilimab Combined With Bevacizumab and XELOX/SOX in Initially Unresectable AFP-positive Gastric/Gastroesop · Phase 2 · not yet recruiting

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

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 NCT04042805 (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 Baocai Xing
Last refreshed: 2 March 2021

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/NCT04042805.

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