NCT04356872 is a Phase 2 clinical trial of Sintilimab in Sarcoma, Soft Tissue, sponsored by Fudan University.

Who is sponsoring NCT04356872?

NCT04356872 is sponsored by Fudan University.

What drugs are being tested in NCT04356872?

Interventions in NCT04356872: Sintilimab, Doxorubicin Hydrochloride, Ifosfamide.

What condition does NCT04356872 study?

NCT04356872 studies Sarcoma, Soft Tissue.

Is NCT04356872 still recruiting?

NCT04356872 is currently status unknown. Last updated 14 July 2020.

Last reviewed 2020-07-14 · How we verify

NCT04356872

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

The Combination of Sintilimab and AI (Doxorubicin, ADM/Ifosfamide, IFO) for the First Line Treatment of Select Type of Metastatic/Unresectable Soft Tissue Sarcoma

Status unknown Phase 2 Last updated 14 July 2020

What this trial tests

Phase 2 trial testing Sintilimab in Sarcoma, Soft Tissue in 45 participants. Status unknown.

Timeline

8 April 2020

Primary endpoint
30 March 2022

30 March 2023

Quick facts

Lead sponsor	Fudan University
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	45
Start date	8 April 2020
Primary completion	30 March 2022
Estimated completion	30 March 2023
Sites	1 location across China

Drugs / interventions tested

Sintilimab — full drug profile →
Doxorubicin Hydrochloride — full drug profile →
Ifosfamide (IFOSFAMIDE) — full drug profile →

Conditions studied

Sarcoma, Soft Tissue — all drugs for Sarcoma, Soft Tissue →

Sponsor

Fudan University

Who can join

Adults 18 to 75, any sex, with Sarcoma, Soft Tissue. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a phase II trial to explore the feasibility of PD-1 immune check point inhibitor, sintilimab, in combination of stand of care chemotherapy in first-line treatment of selected soft tissue sarcoma.

Publications & conference data

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

Improving Immunotherapy Efficacy in Soft-Tissue Sarcomas: A Biomarker Driven and Histotype Tailored Review.
Roulleaux Dugage M, Nassif EF, Italiano A, Bahleda R. · · 2021 · cited 73× · PMID 34925348 · DOI 10.3389/fimmu.2021.775761
Synovial sarcoma: characteristics, challenges, and evolving therapeutic strategies.
Blay JY, von Mehren M, Jones RL, Martin-Broto J, et al · · 2023 · cited 67× · PMID 37625194 · DOI 10.1016/j.esmoop.2023.101618
Recent updates on Sintilimab in solid tumor immunotherapy.
Liu X, Yi Y. · · 2020 · cited 35× · PMID 33292551 · DOI 10.1186/s40364-020-00250-z
Biomarkers for immune checkpoint inhibition in sarcomas - are we close to clinical implementation?
Yiong CS, Lin TP, Lim VY, Toh TB, et al · · 2023 · cited 26× · PMID 37612756 · DOI 10.1186/s40364-023-00513-5
Immunotherapy for Soft Tissue Sarcomas: Anti-PD1/PDL1 and Beyond.
Fazel M, Dufresne A, Vanacker H, Waissi W, et al · · 2023 · cited 15× · PMID 36980528 · DOI 10.3390/cancers15061643
New therapeutics for soft tissue sarcomas: Overview of current immunotherapy and future directions of soft tissue sarcomas.
Seong G, D'Angelo SP. · · 2023 · cited 12× · PMID 37007160 · DOI 10.3389/fonc.2023.1150765
Immune checkpoint inhibitors in sarcomas: a systematic review.
Anastasiou M, Kyriazoglou A, Kotsantis I, Economopoulou P, et al · · 2023 · cited 11× · PMID 38192615 · DOI 10.1016/j.iotech.2023.100407
Emerging mechanisms of immunotherapy resistance in sarcomas.
Florou V, Wilky BA. · · 2022 · cited 9× · PMID 35582530 · DOI 10.20517/cdr.2021.111

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 Sarcoma, Soft Tissue

Currently open trials in the same condition.

NCT07071727 — Short Course of Radiotherapy Prior to Surgery of Soft Tissue Sarcomas · NA · recruiting
NCT06873685 — Soft Tissue Sarcoma: Motor Performance, Robotic Rehabilitation, Nutrition, and Quality of Life · NA · recruiting

Other Fudan University trials

Trials by the same sponsor.

NCT06196671 — Oncolytic Virus Plus PD-1 Inhibitor to Patients With Advanced Pancreatic Cancer · Phase 2 · not yet recruiting
NCT07423611 — ctDNA-Guided Chemotherapy Omission With Ribociclib Plus Endocrine Therapy in HR-Positive/HER2-Negative Breast Cancer · Phase 2 · not yet recruiting
NCT07410559 — Neoadjuvant Imlunestrant Plus Abemaciclib Treatment Guided by Ki67 Index After 2 Weeks for ER-Positive HER2-Negative Bre · Phase 2 · not yet recruiting
NCT07490119 — Becotatug Vedotin Combined With Cetuximab in the Later-line Treatment of Metastatic RAS Wild-type Colorectal Cancer · Phase 2 · not yet recruiting
NCT07497919 — A Study of Becotatug Vedotin Combined With Pucotenlimab in the Treatment of EGFR-Positive Advanced Penile Cancer · Phase 2 · 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 NCT04356872 (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 Fudan University
Last refreshed: 14 July 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/NCT04356872.

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