Definitive chemoradiotherapy combined with anti-PD-1 immunotherapy for inoperable esophageal squamous cell carcinoma: a multicenter real-world study.
Xiongtao Yang, Xiaomin Wang, Qin Xiao...
https://pubmed.ncbi.nlm.nih.gov/40367097Actively Recruiting
Phase 3
Age: 18Years +
All Genders
ID04821778
Cohort Study of Definitive Chemoradiotherapy for Esophageal or Esophagogastric Junction Cancer
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2026-01-21
2000
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating treatment options for patients with unresectable esophageal or esophagogastric junction cancer. This study aims to explore the best ways to combine chemoradiotherapy with immunotherapy or targeted drugs, such as PD-1/PD-L1 antibodies, to improve outcomes. Molecular targeting agents have not yet shown clear benefits for this cancer, so the study focuses on newer cancer immunotherapies and how they might work with radiotherapy. Participants receive one of two treatments: standard chemoradiotherapy alone or chemoradiotherapy combined with immunotherapy or targeted agents. Chemoradiotherapy includes radiation doses between 50-66 Gy over 25-30 fractions and chemotherapy with drugs such as platinum-based, paclitaxel-based, 5-FU analog-based chemotherapy, or nimotuzumab. Immunotherapy involves anti-PD-1/PD-L1 antibodies. Treatments are tailored by the physician's preference, with chemotherapy given every 1 to 3 weeks and nimotuzumab dosed weekly. During the study, participants are closely monitored for overall survival at 1, 2, 3, and 5 years, as well as progression-free survival and treatment side effects. Researchers also assess tumor response and recurrence rates. The study involves follow-up evaluations to track acute and late toxicities, pathological responses, and surgical outcomes when applicable. The total duration of participation may extend over several years to capture long-term results.
CONDITIONS
Brief Title
Chemoradiotherapy in Esophageal or Esophagogastric Junction Cancer
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- 18 years or older
- Diagnosed with esophageal or esophagogastric cancer
- Histologically confirmed squamous cell carcinoma or adenocarcinoma staged I-IVa (AJCC 8th edition)
- Primary treatment performed at Cancer Hospital, Chinese Academy of Medical Sciences
- ECOG Performance Status score of 0 or 1
- Estimated survival time of at least 3 months
- Normal organ and marrow function as defined by specific laboratory values
- Provided informed consent
You will not qualify if you...
- Presence of distant metastasis outside regional lymph nodes or in liver, lung, bone, CNS, or other sites
- History of other cancers within 5 years except cervical carcinoma in situ or non-malignant melanoma skin cancer
- Active infections such as tuberculosis or hepatitis
- History of myocardial infarction within the past 6 months or 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
- Current or recent participation in other clinical trials within 4 weeks
- Pregnant or breastfeeding females
- Lack of medical records
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Duration of chemoradiotherapy cycles as determined by physician's preference
Participants receive definitive chemoradiotherapy, which may include radiotherapy combined with various chemotherapy agents and possibly immunotherapy or targeting agents, according to their assigned treatment arm.
Visits according to treatment schedule, typically weekly or every 1-3 weeks depending on chemotherapy regimen
Follow-up
Duration - Up to 5 years
Participants are monitored for treatment outcomes including survival, toxicities, and disease progression after completing chemoradiotherapy.
Periodic follow-up visits as scheduled for up to 5 years
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
Loading map...
Research Team
X
Xin Wang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here