Chemoradiotherapy for patients with unresectable esophageal cancer
Official title: A Phase I/II Study of Chemoradiotherapy Using Albumin-Bound Paclitaxel and Cisplatin in Unresectable Esophageal Squamous Cell Carcinomas Based on Nutritional Risk Screening Score (NRS2002)
Run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · NCT04278287 · Data updated 2026-11-12
This study is testing a new combination of chemotherapy and radiation to see if it helps people with advanced esophageal cancer while also focusing on their nutrition to improve their treatment experience.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 105 (estimated) |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 5 sites (Anyang, Henan and 4 other locations) |
| Status | Recruiting |
| Started | October 1, 2019 |
| Main results expected | December 2025 |
| Study ends | December 2026 |
| Registry record updated | December 13, 2024 |
| Trial ID | NCT04278287 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 75 with unresectable esophageal squamous cell carcinoma and a nutritional risk score of less than 3.
✕Probably not a fit
Patients with resectable tumors or those with severe nutritional risk (NRS2002 score of 3 or higher) may 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 study evaluates the one-year local tumor control rate of a chemoradiotherapy regimen combining albumin-bound paclitaxel and cisplatin in patients with unresectable esophageal squamous cell carcinoma (ESCC). Participants are selected based on the Nutritional Risk Screening (NRS2002) tool, which assesses their nutritional risk factors. The study aims to improve treatment response and quality of life by addressing nutritional needs alongside cancer treatment. Patients will receive the chemoradiotherapy regimen and be monitored for outcomes over the course of the study.
Why it matters
Potential benefit: If successful, this approach could enhance local tumor control and improve the quality of life for patients with unresectable esophageal cancer.
How similar studies have gone: Other studies have shown promising results with similar chemoradiotherapy approaches, indicating potential for success in this trial.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18\~75 years * Pathologically or cytologically proven unresectable esophageal squamous cell carcinomas in patients staged as T3N1M0-1b and T4N0-1M0-1b(AJCC 6th TNM staging,M1b limited to clavicular or celiac lymph node metastasis) * Primary treatment performed in Cancer Hospital, Chinese Academy of Medical Sciences * ECOG PS score: 0\~1 * NRS2002 score \<3 * Estimated survival time ≥3 months * Normal organ and marrow function as defined below: Hemoglobin: greater than or equal to 100g/L ;Leukocytes: greater than or equal to 4,000 G/L; Neutrophil: greater than or equal to 2,000 G/L; Platelets: greater than or equal to 100,000/mm3 ; Creatinine: less than or equal to 1.5 times the upper limit or CCR greater than or equal to 60 ml/min; AST/ALT: less than or equal to 2.5 times the upper limit; Total bilirubin: less than or equal to 1.5 times the upper limit; INR: less than or equal to 1.5 times the upper limit; APTT: less than or equal to 1.5 times the upper limit; PT: less than or equal to 1.5 times the upper limit * Informed consent Exclusion Criteria: * With any distant metastasis out of regional lymphatic drainage or in liver, lung, bone, CNS, etc * Patients with other cancer history in 5 years except cervical carcinoma in situ and non-malignant melanoma skin cancer * Existing active infection such as active tuberculosis and hepatitis * History of myocardial infarction within the past 6 months or history of ventricular arrhythmia * Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness * History of allergic reactions attributed to paclitaxel, albumin or cisplatin * Participation in other clinical trials currently or within 4 weeks of selection * Pregnant or lactating females
Where it's running
-
Department 4th of Radiation Oncology, Anyang Cancer Hospital
Anyang, Henan, China Recruiting -
Hunan Cancer Hospital, the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University
Changsha, Hunan, China Recruiting -
Department of Radiation oncology, Jiangsu Cancer Hospital/Jiangsu Institute of Cancer Research/The affiliated Cancer Hospital of Nanjing Medical University
Nanjing, Jiangsu, China Recruiting -
Department of Radiation oncology, Jiangsu Province Hospital/The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China Recruiting -
Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
Beijing, China Recruiting
Study contacts
- Principal investigator: Xin Wang, MD — Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
- Study coordinator: Xin Wang, MD
- Email: beryl_wx2000@163.com
- Phone: +861013311583220
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Toripalimab plus capecitabine after chemoradiotherapy for esophageal squamous cell carcinoma
This trial will test whether giving toripalimab together with low‑dose capecitabine after definitive chemoradiotherapy helps people with locally advanced esophageal squamous cell carcinoma live longer and have fewer recurrences.
-
Nimotuzumab with Chemoradiotherapy for Esophageal Cancer
This study is testing if a combination of a new antibody treatment, chemotherapy, and radiation can help older or malnourished patients with advanced esophageal cancer feel better and improve their chances of recovery.
-
Combining immunotherapy and chemoradiotherapy for esophageal cancer treatment
This study is testing if combining a new immunotherapy drug with traditional chemoradiotherapy can help people with advanced esophageal cancer have better treatment results.
-
Using sintilimab after chemoradiotherapy for elderly patients with esophageal cancer
This study is testing if adding a new treatment called sintilimab after chemotherapy and radiation can help older patients with esophageal cancer live longer and healthier.
-
Nimotuzumab with Chemoradiotherapy for Unresectable Esophageal Cancer
This study is testing if adding a new drug called nimotuzumab to chemotherapy and radiation can help patients with advanced esophageal cancer who haven't improved with earlier treatments.
-
PF-08098488 in adults with advanced solid tumors
This study tests PF-08098488 in adults whose cancer has progressed or returned after prior treatment.
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.