Who is sponsoring NCT04072679?

NCT04072679 is sponsored by Chinese Academy of Medical Sciences.

What drugs are being tested in NCT04072679?

Interventions in NCT04072679: Sintilimab+IBI305.

What condition does NCT04072679 study?

NCT04072679 studies Advanced Hepatocellular Carcinoma.

Is NCT04072679 still recruiting?

NCT04072679 is currently completed. Last updated 1 February 2021.

Last reviewed 2021-02-01 · How we verify

NCT04072679

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

Safety and Efficacy Study of Sintilimab Combined With IBI305 in Patients With Advanced Hepatocellular Carcinoma

Completed Phase 1 Last updated 1 February 2021

What this trial tests

Phase 1 trial testing Sintilimab+IBI305 in Advanced Hepatocellular Carcinoma in 50 participants. Completed in 11 November 2020.

Timeline

11 October 2018

Primary endpoint
31 March 2020

11 November 2020

Quick facts

Lead sponsor	Chinese Academy of Medical Sciences
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	11 October 2018
Primary completion	31 March 2020
Estimated completion	11 November 2020
Sites	1 location across China

Drugs / interventions tested

Sintilimab+IBI305 — full drug profile →

Conditions studied

Advanced Hepatocellular Carcinoma — all drugs for Advanced Hepatocellular Carcinoma →

Sponsor

Chinese Academy of Medical Sciences — full company profile →

Who can join

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

Sponsor's own description

This is a Phase Ib study to evaluate the safety, tolerability and efficacy of Sintilimab combined with IBI305 in patients with advanced hepatocellular carcinoma in China.

Publications & conference data

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

Sintilimab: A Promising Anti-Tumor PD-1 Antibody.
Zhang L, Mai W, Jiang W, Geng Q. · · 2020 · cited 109× · PMID 33324564 · DOI 10.3389/fonc.2020.594558
Liver Cancer Immunity.
Ilyas SI, Wang J, El-Khoueiry AB. · · 2021 · cited 81× · PMID 32516437 · DOI 10.1002/hep.31416
Serum Concentration of CD137 and Tumor Infiltration by M1 Macrophages Predict the Response to Sintilimab plus Bevacizumab Biosimilar in Advanced Hepatocellular Carcinoma Patients.
Zhang W, Gong C, Peng X, Bi X, et al · · 2022 · cited 41× · PMID 35275208 · DOI 10.1158/1078-0432.ccr-21-3972
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
Recent updates on Sintilimab in solid tumor immunotherapy.
Liu X, Yi Y. · · 2020 · cited 35× · PMID 33292551 · DOI 10.1186/s40364-020-00250-z
Immune Checkpoint Inhibitors in Hepatocellular Carcinoma: An Overview.
van Doorn DJ, Takkenberg RB, Klümpen HJ. · · 2020 · cited 18× · PMID 33374927 · DOI 10.3390/ph14010003
Combination of molecularly targeted therapies and immune checkpoint inhibitors in the new era of unresectable hepatocellular carcinoma treatment.
Liu ZL, Liu JH, Staiculescu D, Chen J. · · 2021 · cited 17× · PMID 34104226 · DOI 10.1177/17588359211018026
Immunotherapy with Checkpoint Inhibitors for Hepatocellular Carcinoma: Where Are We Now?
Tovoli F, De Lorenzo S, Trevisani F. · · 2020 · cited 17× · PMID 33023131 · DOI 10.3390/vaccines8040578

Verify or expand the search:

Other recruiting trials for Advanced Hepatocellular Carcinoma

Currently open trials in the same condition.

NCT07166406 — Testing Immunotherapy With or Without Stereotactic Body Radiation Therapy in Patients With Advanced Liver Cancer, HELIO- · Phase 3 · recruiting
NCT07174570 — Celecoxib, Durvalumab and Tremelimumab for the Treatment of Patients With Advanced or Metastatic Liver Cancer · Phase 2 · recruiting
NCT07227012 — Symbiotic-GI-13: A Study to Learn About Study Medicine Called PF-08634404 as a Single Treatment and Combination Treatmen · Phase 1, PHASE2 · recruiting
NCT06811116 — Testing the Addition of an Anti-cancer Drug, Sapanisertib, to the Usual Chemotherapy Treatment (Cabozantinib) in Metasta · Phase 1, PHASE2 · recruiting
NCT06789848 — Ligufalimab and Cadonilimab in Advanced Liver Cancers · Phase 2 · recruiting

Other Chinese Academy of Medical Sciences trials

Trials by the same sponsor.

NCT05522894 — AK104 Alone or in Combination With Chemotherapy in the First-line Treatment of ESCC · Phase 2 · unknown
NCT05499715 — A Phase I Clinical Study to Evaluate the Safety, the Tolerability, the Pharmacokinetic Characteristics and the Efficacy · Phase 1 · unknown
NCT05484024 — Short-course Radiotherapy Followed by Chemotherapy and PD-1 Inhibitor for Locally Advanced Rectal Cancer · Phase 2, PHASE3 · not yet recruiting
NCT05543070 — Low-dose Radiotherapy in iNHL · Phase 2 · unknown
NCT05460403 — Adjuvant Radiotherapy for Patients With Esophageal Squamous Cell Carcinoma After R0 Resection · unknown

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 NCT04072679 (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 Chinese Academy of Medical Sciences
Last refreshed: 1 February 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/NCT04072679.

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