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
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 456 (estimated) |
| Sponsor | Henan Cancer Hospital Government |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Zhengzhou, Henan) |
| Status | Recruiting |
| Started | October 22, 2019 |
| Main results expected | December 21, 2023 |
| Study ends | December 21, 2028 |
| Registry record updated | August 9, 2022 |
| Trial ID | NCT04138212 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
- Study coordinator: Haibo Sun
- Email: sunny-haipo@hotmail.com
- Phone: +8615188301091
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Radiotherapy target-volume choices in locally advanced esophageal cancer during immunotherapy
This observational study looks at how doctors outline the radiation area for locally advanced esophageal squamous cell cancer patients treated with radiotherapy and immunotherapy to see which approaches correlate with better outcomes.
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Sacituzumab Govitecan plus Tislelizumab for advanced esophageal cancer
This phase II study tests whether the cancer-fighting drug sacituzumab tirumotecan (SKB264) combined with tislelizumab can help adults with advanced esophageal squamous cell carcinoma that progressed after initial immunotherapy.
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Neoadjuvant therapy with adebrelimab, famitinib, and chemotherapy for resectable ESCC
This study tests a combination of adebrelimab, famitinib, and chemotherapy before surgery in people with resectable locally advanced esophageal squamous cell carcinoma to see if it can lead to a complete tumor disappearance at the time of surgery.
-
SKB500 combinations for esophageal squamous cell carcinoma
This study tests SKB500 combined with other drugs to see if it is safe and shows early signs of activity in adults with unresectable or metastatic esophageal squamous cell carcinoma who have limited prior treatment.
-
Neoadjuvant Cardonilizumab With Chemotherapy Before Surgery for Locally Advanced Esophageal Squamous Cell Carcinoma
This study tests whether adding cardonilizumab to preoperative chemotherapy (versus chemoradiotherapy) helps patients with locally advanced ESCC have a better chance at complete tumor removal and longer survival.
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Surgery or chemoradiotherapy after neoadjuvant immunochemotherapy for esophageal squamous cell carcinoma
In people with locally advanced ESCC who respond to neoadjuvant immunochemotherapy, this study tests whether organ preservation with treatment other than surgery can be as effective as radical esophagectomy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.