Actively Recruiting
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)
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2024-12-13
105
Participants Needed
5
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating 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). This Phase I/II study uses the Nutritional Risk Screening (NRS2002) tool to select participants and manage nutritional risk factors that may influence treatment outcomes and quality of life. Participants will receive intensity-modulated radiation therapy, volume modulated arc therapy, or tomotherapy concurrently with weekly intravenous infusions of albumin-bound paclitaxel (100 mg per day) and cisplatin (25 mg/m2) over 5 to 6 weeks. Radiation doses are given in 28 fractions over 5.5 weeks. This treatment combination aims to control tumor growth locally while monitoring side effects. During the study, patients will undergo regular imaging scans such as CT or PET to assess tumor response and detect progression. Laboratory tests will monitor overall health and treatment side effects. Researchers will evaluate local tumor control at one year, along with secondary outcomes like survival rates, disease progression, treatment toxicity, nutritional status, and quality of life. Follow-up assessments include radiomics and ctDNA analyses to provide detailed insights into treatment effects and patient outcomes.
CONDITIONS
Brief Title
Chemoradiotherapy in Unresectable Esophageal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Pathologically or cytologically confirmed unresectable esophageal squamous cell carcinoma staged as T3N1M0-1b or T4N0-1M0-1b according to AJCC 6th TNM staging
- Primary treatment performed at Cancer Hospital, Chinese Academy of Medical Sciences
- ECOG performance status score of 0 to 1
- Nutritional Risk Screening (NRS2002) score less than 3
- Estimated survival time of at least 3 months
- Normal organ and bone marrow function as defined (hemoglobin ≥100g/L; leukocytes ≥4,000 G/L; neutrophils ≥2,000 G/L; platelets ≥100,000/mm3; creatinine ≤1.5 times upper limit or CCR ≥60 ml/min; AST/ALT ≤2.5 times upper limit; total bilirubin ≤1.5 times upper limit; INR, APTT, PT ≤1.5 times upper limit)
- Informed consent provided
You will not qualify if you...
- Presence of distant metastasis outside regional lymph nodes or metastasis in liver, lung, bone, central nervous system, etc.
- History of other cancers within 5 years except cervical carcinoma in situ and non-malignant melanoma skin cancer
- Active infections such as tuberculosis or hepatitis
- Myocardial infarction within past 6 months or history of ventricular arrhythmia
- Uncontrolled illnesses including active infection, symptomatic heart failure, unstable angina, cardiac arrhythmia, or psychiatric illness
- History of allergic reactions to paclitaxel, albumin, or cisplatin
- Participation in other clinical trials currently or within 4 weeks prior to selection
- Pregnancy or lactation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 to 6 weeks
Participants receive a combination chemoradiotherapy regimen involving weekly intravenous infusions of albumin-bound paclitaxel and cisplatin alongside intensity-modulated radiation therapy for 5 to 6 weeks.
Weekly visits for treatment and monitoring
Duration - Up to 1 year or longer
Participants undergo regular follow-ups including imaging studies and laboratory assessments to evaluate tumor response and monitor overall health after treatment completion.
Periodic visits with imaging and blood tests over 1 year
Trial Site Locations
Total: 5 locations
1
Department 4th of Radiation Oncology, Anyang Cancer Hospital
Anyang, Henan, China, 455001
Actively Recruiting
2
Hunan Cancer Hospital, the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University
Changsha, Hunan, China, 410031
Actively Recruiting
3
Department of Radiation oncology, Jiangsu Cancer Hospital/Jiangsu Institute of Cancer Research/The affiliated Cancer Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210009
Actively Recruiting
4
Department of Radiation oncology, Jiangsu Province Hospital/The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China, 210029
Actively Recruiting
5
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, 100021
Actively Recruiting
Research Team
X
Xin Wang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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