Comparing two treatment approaches for esophageal squamous cell carcinoma

Is this trial a fit for you?

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 is a phase III, multicenter, prospective randomized controlled study that evaluates the effectiveness of radical chemoradiotherapy versus radical chemoradiotherapy combined with consolidation chemotherapy in patients with inoperable esophageal squamous cell carcinoma. Participants will be assigned to one of two groups: one receiving only chemoradiotherapy and the other receiving chemoradiotherapy followed by additional chemotherapy. The study aims to compare survival rates and side effects over a period of time, focusing on both overall survival and progression-free survival. The chemotherapy regimens include specific drugs administered in a structured manner, and the study will also assess the quality of life of participants.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18-70 years old, not limited to male or female; at least able to take liquid diet;
2. Esophageal squamous cell carcinoma proved by histopathology;
3. Esophageal squamous cell carcinoma that is inoperable or refuses surgery,
4. According to the 2017 8th edition of AJCC esophageal cancer new staging criteria, the tumor is T2N0M0-TxNxM0 stage;
5. ECOG 0-1; life expectancy \> 6 months;
6. No chemotherapy was used before selection;
7. No history of radiotherapy;
8. No surgical treatment;
9. No serious allergic history;
10. Hemoglobin 100 g/L, WBC3.5109/L, neutrophils 1.5109, platelets 100109/L; CR1.5 upper limit of normal, TB2.5 upper limit of normal, AST and ALT2.5 upper normal limit, AKP2.5 upper normal limit ; Be able to understand the research and have signed the informed consent;

Exclusion Criteria:

1. History of malignant tumors in other parts;
2. Duplicate carcinoma of the esophagus;
3. Pregnant or lactating patients;
4. Fertility but not using contraceptive measures;
5. Serious comorbidities: very high-risk hypertension, severe pulmonary function impairment, massive myocardial infarction, cardiac function ≥ grade II, mental history and severe diabetes;
6. During the active period of infectious diseases;
7. Participate in other clinical trials at present or within four weeks before enrollment;
8. Simultaneous treatment with other anti-cancer drugs (including anti-cancer traditional Chinese medicine);
9. After esophageal stent placement;
10. Cases with perforation tendency;
11. Have a history of organ transplantation.
12. Widespread metastases throughout the body, including lung, liver, bone, and intracranial metastases;
13. Known or suspected allergic to chemotherapy drugs; According to the judgment of the investigator, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study.

Where it's running

• The First Affiliated Hospital of Nanjing Medical University
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Xiaolin GE, MM
• Email: doctorsxl@163.com
• Phone: 13951818797

Similar studies

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

• Predicting how well chemotherapy will work for esophageal cancer patients

  This study is testing if DNA changes in biopsy samples can help doctors predict how well chemotherapy will work for patients with esophageal cancer, so those who might not benefit can avoid unnecessary treatment.

  Recruiting City of Hope Medical Center · Chūō, Yamanashi · NCT06490003

• 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.

  Recruiting Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing, Beijing Municipality · NCT07858630

• 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.

  Recruiting at 2 sites Phase 2 Shanghai Chest Hospital · Shanghai and 1 other locations · NCT07811752

• 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.

  Recruiting Phase 2 First Affiliated Hospital Xi'an Jiaotong University · Xi'an, Shannxi · NCT07796113

• 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.

  Recruiting at 24 sites Phase 2 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Changchun and 23 other locations · NCT07700667

• 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.

  Recruiting Phase 2 Tongji Hospital · Wuhan, Hubei · NCT07699185

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.