Clinical trial NCT04821778: Chemoradiotherapy in Esophageal or Esophagogastric Junction Cancer
Official title: Cohort Study of Definitive Chemoradiotherapy for Esophageal or Esophagogastric Junction Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Esophagus Cancer
Esophagogastric Junction Cancer
Chemoradiation
Targeted Therapy
Immunotherapy
Chemotherapy Effect
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2021-03-30
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* ≥18 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.

Primary outcomes:
measure: Overall survival
timeFrame: 1year
measure: Overall survival
timeFrame: 2 year
measure: Overall survival
timeFrame: 3 year
measure: Overall survival
timeFrame: 5 year
Secondary outcomes:
measure: Progression free survival
timeFrame: 1 year, 2 year, 3 year, 5 year
measure: Number of participants with Acute and late toxicities of radiotherapy,chemotherapy and immunotherapy
timeFrame: 3 months
measure: Pathological response rate
timeFrame: 3 months
measure: R0 resection rate
timeFrame: 3 months
measure: Locoregional recurrence free survival
timeFrame: 1 year, 2 year, 3 year, 5 year
measure: Distant metastasis free survival
timeFrame: 1 year, 2 year, 3 year, 5 year
Other outcomes:
measure: Analysis of correlation between radiomics signature extracted by LASSO and the number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
timeFrame: 1 year, 2 year, 3 year, 5 year
measure: Radiomics analysis
timeFrame: 1 year, 2 year, 3 year, 5 year
Locations:
city: Anyang
country: China
facility: Department 4th of Radiation Oncology, Anyang Cancer Hospital
state: Henan
city: Changsha
country: China
facility: Hunan Cancer Hospital, the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University
state: Hunan
city: Nanjing
country: China
facility: Department of Radiation oncology, Jiangsu Cancer Hospital/Jiangsu Institute of Cancer Research/The affiliated Cancer Hospital of Nanjing Medical University
state: Jiangsu
city: Nanjing
country: China
facility: Department of Radiation oncology, Jiangsu Province Hospital/The First Affiliated Hospital with Nanjing Medical University
state: Jiangsu
city: Beijing
country: China
facility: 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)
Study officials:
References: