NCT04138212 (HCHTOG1903) is a Phase 3 clinical trial of Paclitaxel, Cisplatin in Esophageal Squamous Cell Carcinoma, sponsored by Henan Cancer Hospital.

Who is sponsoring NCT04138212?

NCT04138212 is sponsored by Henan Cancer Hospital.

What drugs are being tested in NCT04138212?

Interventions in NCT04138212: Paclitaxel, Cisplatin, neoadjuvant chemoradiation therapy.

What condition does NCT04138212 study?

NCT04138212 studies Esophageal Squamous Cell Carcinoma.

Is NCT04138212 still recruiting?

NCT04138212 is currently recruiting now. Last updated 9 August 2022.

Last reviewed 2022-08-09 · How we verify

NCT04138212: HCHTOG1903

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

Neoadjuvant Chemotherapy Versus Neoadjuvant Chemoradiotherapy for Resectable Locally Advanced Esophageal Cancer (HCHTOG1903)

Recruiting now Phase 3 Last updated 9 August 2022

What this trial tests

Phase 3 trial testing Paclitaxel, Cisplatin in Esophageal Squamous Cell Carcinoma in 456 participants. Currently enrolling.

Timeline

22 October 2019

Primary endpoint
21 December 2023

21 December 2028

Quick facts

Lead sponsor	Henan Cancer Hospital
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	456
Start date	22 October 2019
Primary completion	21 December 2023
Estimated completion	21 December 2028
Sites	1 location across China

Drugs / interventions tested

Paclitaxel, Cisplatin
neoadjuvant chemoradiation therapy

Conditions studied

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

Sponsor

Henan Cancer Hospital

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

Multimodal treatment combining surgery with chemotherapy and/or radiotherapy is necessary to improve the chances of survival in patients with locally advanced thoracic esophageal cancer. However, there is no consensus about the neoadjuvant treatment for resectable locally advanced esophageal squamous cell carcinoma. The aim of current randomized controlled clinical trail is to investigate the impact of neoadjuvant chemotherapy plus surgery and neoadjuvant chemoradiation therapy plus surgery on overall survival for patients with resectable locally advanced esophageal squamous cell carcinoma. The investigators plan to enroll 456 patients with locally advanced esophageal squamous cell carcinoma in 3 years. Eligible patients will be randomized into neoadjuvant chemotherapy group (paclitaxel 175mg/m2 plus cisplatin 75mg/m2, q21d, 2 cycles) or neoadjuvant chemoradiation group (41.4Gy, 1.8Gy\*23d plus paclitaxel 50mg/m2 plus carboplatin AUC=2, q1w, 5 cycles). The primary endpoint is 5 year overall survival and the secondary endpoints include 5 year disease-free survival, adverse events, pathologic complete response, postoperative complications, quality of life. The biomarkers predicting the sensitivity of neoadjuvant therapy will be explored.

Publications & conference data

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

Current status and perspectives of esophageal cancer: a comprehensive review.
Jiang W, Zhang B, Xu J, Xue L, et al · · 2025 · cited 28× · PMID 39723635 · DOI 10.1002/cac2.12645
Clinical evidence for association of neoadjuvant chemotherapy or chemoradiotherapy with efficacy and safety in patients with resectable esophageal carcinoma (NewEC study).
Zhou HY, Zheng SP, Li AL, Gao QL, et al · · 2020 · cited 18× · PMID 32637899 · DOI 10.1016/j.eclinm.2020.100422
Neoadjuvant Therapy for Locally Advanced Esophageal Cancers.
Huang R, Qiu Z, Zheng C, Zeng R, et al · · 2022 · cited 15× · PMID 35463306 · DOI 10.3389/fonc.2022.734581
Neoadjuvant chemotherapy versus neoadjuvant chemoradiotherapy for locally advanced oesophageal squamous cell carcinoma: a single-Centre, open-label, randomized, controlled, clinical trial (HCHTOG1903).
Sun HB, Xing WQ, Liu XB, Zheng Y, et al · · 2020 · cited 12× · PMID 32293362 · DOI 10.1186/s12885-020-06824-2
Neoadjuvant Treatment Strategies for Resectable Proximal Gastric, Gastroesophageal Junction and Distal Esophageal Cancer.
Ahmad MU, Javadi C, Poultsides GA. · · 2022 · cited 6× · PMID 35406527 · DOI 10.3390/cancers14071755

Verify or expand the search:

Other trials of Paclitaxel, Cisplatin

Trials testing the same drug.

NCT06588335 — BTLA Inhibitor (JS004) Combined with Toripalimab and Chemotherapy in the Perioperative Treatment of Resectable Locally A · Phase 2 · not yet recruiting
NCT05520619 — Combination of Tislelizumab and Chemoradiotherapy in Esophageal Cancer (EC-CRT-002) · Phase 2 · active not recruiting
NCT03468010 — A Trial Comparing Adjuvant Chemotherapy With Observation After Concurrent Chemoradiotherapy of Cervical Cancer (With Pel · Phase 3 · unknown
NCT03201861 — Addition of Cisplatin to Adjuvant Chemotherapy for Early Stage Breast Cancer in High-Risk Women · Phase 3 · 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 Henan Cancer Hospital trials

Trials by the same sponsor.

NCT07442890 — A Cohort Study on the Prevention of Nausea and Vomiting Induced by Concurrent Chemoradiotherapy for Lung Cancer Using Ro · NA · not yet recruiting
NCT07472621 — Real-World Effectiveness and Safety of Glofitamab in Primary Refractory and Early Relapsed Diffuse Large B-Cell Lymphoma · not yet recruiting
NCT07459608 — Efficacy and Safety of Lisaftoclax (APG-2575) Monotherapy in Patients With Indolent Lymphoma · Phase 2 · not yet recruiting
NCT07400575 — Anlotinib in Cross-line Treatment of NSCLC and SCLC · not yet recruiting
NCT07332221 — Application of Toripalimab as Adjuvant Therapy After Esophageal Cancer Surgery: A Multicenter Clinical Trial · Phase 3 · 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 NCT04138212 (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 Henan Cancer Hospital
Last refreshed: 9 August 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/NCT04138212.

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