Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 18 to 70

Comparing chemotherapy and chemoradiotherapy before surgery for esophageal cancer

Official title: Neoadjuvant Chemotherapy Versus Neoadjuvant Chemoradiotherapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma: a Randomized, Controlled Clinical Trial (HCHTOG1903)

Run by Henan Cancer Hospital · NCT04138212 · Data updated 2026-11-12

This study is testing whether giving patients with esophageal cancer chemotherapy or a combination of chemotherapy and radiation before surgery helps them live longer.

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years to 70 Years
SexAll
Enrollment456 (estimated)
SponsorHenan Cancer Hospital
Government
Drugs / interventionschemotherapy
Locations1 site (Zhengzhou, Henan)
StatusRecruiting
StartedOctober 22, 2019
Main results expectedDecember 21, 2023
Study endsDecember 21, 2028
Registry record updatedAugust 9, 2022
Trial IDNCT04138212 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are patients diagnosed with locally advanced esophageal squamous cell carcinoma who meet specific staging criteria and have no prior cancer treatment.

Probably not a fit

Patients with metastatic disease, previous cancer treatment history, or those who cannot undergo surgery will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of neoadjuvant chemotherapy versus neoadjuvant chemoradiotherapy in improving overall survival for patients with resectable locally advanced esophageal squamous cell carcinoma. A total of 456 patients will be randomly assigned to receive either chemotherapy with paclitaxel and cisplatin or chemoradiotherapy with paclitaxel and carboplatin combined with radiation before undergoing surgery. The study seeks to determine which treatment approach offers better survival outcomes over a five-year period.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment protocol for patients with locally advanced esophageal cancer, potentially improving survival rates.

How similar studies have gone: Previous studies have shown varying success with neoadjuvant therapies in esophageal cancer, but this specific comparison of chemotherapy versus chemoradiotherapy is less commonly tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* cT2-T4aN+M0 or cT3-4aN0M0 (8th TNM staging system) thoracic esophageal squamous cell carcinoma
* No metastatic cervical lymph node
* No anti-cancer treatment
* No contraindication for esophagectomy
* No contraindication for chemotherapy or chemoradiation therapy
* PS score 0-1
* Written consent is obtained

Exclusion Criteria:

* Previous cancer treatment history
* Concurrent cancer disease in other site
* Tumor length ≥8cm
* Tumor width ≥5cm
* Need continuous steroid treatment
* Cardiac infarction in 6 months
* Psychotic patient
* Can not achieve R0 resection
* Gastric tube can not be used for reconstruction after esophagectomy
* Pregnant woman

Where it's running

  • Henan Cancer Hospital
    Zhengzhou, Henan, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.