NCT03946969 is a Phase 2 clinical trial of Sintilimab in Esophageal Squamous Cell Carcinoma, sponsored by The First Affiliated Hospital with Nanjing Medical University.

Who is sponsoring NCT03946969?

NCT03946969 is sponsored by The First Affiliated Hospital with Nanjing Medical University.

What drugs are being tested in NCT03946969?

Interventions in NCT03946969: Sintilimab, Liposomal Paclitaxel + Cisplatin + S-1.

What condition does NCT03946969 study?

NCT03946969 studies Esophageal Squamous Cell Carcinoma.

Is NCT03946969 still recruiting?

NCT03946969 is currently status unknown. Last updated 19 July 2022.

Last reviewed 2022-07-19 · How we verify

NCT03946969

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

Sintilimab in Combination With Chemotherapy in Neoadjuvant Treatment of Potentially Resectable Esophageal Cancer

Status unknown Phase 2 Last updated 19 July 2022

What this trial tests

Phase 2 trial testing Sintilimab in Esophageal Squamous Cell Carcinoma in 30 participants. Status unknown.

Timeline

9 May 2019

Primary endpoint
9 November 2021

31 October 2022

Quick facts

Lead sponsor	The First Affiliated Hospital with Nanjing Medical University
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	9 May 2019
Primary completion	9 November 2021
Estimated completion	31 October 2022
Sites	1 location across China

Drugs / interventions tested

Sintilimab — full drug profile →
Liposomal Paclitaxel + Cisplatin + S-1 — full drug profile →

Conditions studied

Esophageal Squamous Cell Carcinoma — all drugs for Esophageal Squamous Cell Carcinoma →

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Who can join

Adults 18 to 70, any sex, with Esophageal Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study aims to investigate the safety and efficacy of sintilimab combined with platinum-based chemotherapy in neoadjuvant treatment of potentially resectable esophageal cancer.

Publications & conference data

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

Advances and challenges in the treatment of esophageal cancer.
He S, Xu J, Liu X, Zhen Y. · · 2021 · cited 223× · PMID 34900524 · DOI 10.1016/j.apsb.2021.03.008
Understanding Esophageal Cancer: The Challenges and Opportunities for the Next Decade.
Yang J, Liu X, Cao S, Dong X, et al · · 2020 · cited 134× · PMID 33014854 · DOI 10.3389/fonc.2020.01727
Evaluation of Clinical and Safety Outcomes of Neoadjuvant Immunotherapy Combined With Chemotherapy for Patients With Resectable Esophageal Cancer: A Systematic Review and Meta-analysis.
Ge F, Huo Z, Cai X, Hu Q, et al · · 2022 · cited 94× · PMID 36322089 · DOI 10.1001/jamanetworkopen.2022.39778
Neoadjuvant sintilimab and chemotherapy in patients with potentially resectable esophageal squamous cell carcinoma (KEEP-G 03): an open-label, single-arm, phase 2 trial.
Chen X, Xu X, Wang D, Liu J, et al · · 2023 · cited 83× · PMID 36759013 · DOI 10.1136/jitc-2022-005830
Toripalimab Plus Paclitaxel and Carboplatin as Neoadjuvant Therapy in Locally Advanced Resectable Esophageal Squamous Cell Carcinoma.
He W, Leng X, Mao T, Luo X, et al · · 2022 · cited 79× · PMID 35305102 · DOI 10.1093/oncolo/oyab011
Revolutionization in Cancer Therapeutics via Targeting Major Immune Checkpoints PD-1, PD-L1 and CTLA-4.
Pandey P, Khan F, Qari HA, Upadhyay TK, et al · · 2022 · cited 67× · PMID 35337133 · DOI 10.3390/ph15030335
Neoadjuvant sintilimab plus chemotherapy for locally advanced esophageal squamous cell carcinoma: a single-arm, single-center, phase 2 trial (ESONICT-1).
Zhang Z, Hong ZN, Xie S, Lin W, et al · · 2021 · cited 66× · PMID 34926667 · DOI 10.21037/atm-21-5381
Neoadjuvant immunotherapy for resectable esophageal cancer: A review.
Li Q, Liu T, Ding Z. · · 2022 · cited 43× · PMID 36569908 · DOI 10.3389/fimmu.2022.1051841

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 Esophageal Squamous Cell Carcinoma

Currently open trials in the same condition.

NCT07503808 — A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types · Phase 1 · recruiting
NCT07385001 — A Prospective, Multicenter, Phase Ib/II Trial of Ivonescimab (AK112) Combined With Albumin-Paclitaxel and Cisplatin as N · Phase 1, PHASE2 · recruiting
NCT07217171 — A Study Evaluating the Safety, Efficacy, and Pharmacokinetics (PK) of EVOLVE104 in Participants With Advanced Urothelial · Phase 1 · recruiting
NCT07109726 — A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations · Phase 1, PHASE2 · recruiting
NCT07090499 — A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors · Phase 1 · recruiting

Other The First Affiliated Hospital with Nanjing Medical University trials

Trials by the same sponsor.

NCT07377981 — An Exploratory Study of the Efficacy and Safety of Esketamine and Dexmedetomidine in Non-Intubated ICU Patients With Hyp · Phase 4 · not yet recruiting
NCT07523789 — Comparison of Chemotherapy and Immunotherapy in Neoadjuvant Therapy for TNBC · not yet recruiting
NCT07464756 — SHR-1701 With or Without Apatinib in Combination With Chemotherapy as Neoadjuvant Therapy for Gastric Cancer · Phase 2 · not yet recruiting
NCT07482826 — Full-Endoscopic Decompression vs. Endoscopic Lumbar Fusion for Middle-Aged and Older Adults With Spinal Stenosis · NA · not yet recruiting
NCT07558863 — Effect of GLP-1RA on Cardiac Autonomic Neuropathy in Type 2 Diabetes · Phase 4 · 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 NCT03946969 (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 The First Affiliated Hospital with Nanjing Medical University
Last refreshed: 19 July 2022

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/NCT03946969.

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