Chemoradiotherapy in Esophageal or Esophagogastric Junction Cancer

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    2000
  • sponsor
    Chinese Academy of Medical Sciences
Updated on 6 April 2021

Summary

Definitive chemoradiotherapy is the standard of care in unresectable esophageal or esophagogastric cancer. A multidisciplinary approach, including chemotherapy and radiotherapy, is important for these patients. Morerover, molecular targeting agents does not show clear efficacy in EC up to now. Nowadays, the pace of development of cancer immunotherapies is accelerating. Clinical evidence of the efficacy of immune checkpoint inhibitors and adoptive immunotherapies herald the onset of a new era in cancer immunotherapy. There have also been recent developments to provide a promising frontier in extending the use of immunotherpay or targeting agents to radiotherapy. The purpose of this study was to explore the optimal treatment modalities including PD-1/PD-L1 antibody or targeted drug for patients with unresectable esophageal or esophagogastric junction cancer.

Details
Condition Esophageal Cancer, Esophageal Cancer, Immunotherapy, Chemoradiation, Chemotherapy Effect, Chemoradiotherapy, Targeted Therapy, Esophagogastric Junction Cancer, esophagus cancer, oesophageal cancer, immunotherapies
Treatment Radiotherapy, Nimotuzumab, Immunotherapy, Platinum Based Chemotherapy, Paclitaxel based chemotherapy, 5-FU Analog based chemotherapy
Clinical Study IdentifierNCT04821778
SponsorChinese Academy of Medical Sciences
Last Modified on6 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

years
Esophageal or Esophagogastric cancer
Histologically proven squamous cell carcinoma or adenocarcinoma in patients staged as I-IVa(AJCC 8th)
Primary treatment performed in Cancer Hospital, Chinese Academy of Medical Sciences
ECOG PS score: 0~1
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
Absence of medical records
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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