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Recruiting NCT04821843

Neoadjuvant Treatment Modalities in Esophageal Cancer

Phase III Interventional Esophageal Cancer Chemotherapy Effect Chemoradiation Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Platinum based chemotherapy, Paclitaxel based chemotherapy, Radiotherpay, Surgery.
Who it may be relevant to
Registry conditions: Esophageal Cancer, Chemotherapy Effect, Chemoradiation, Surgery. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Cohort Study of Neoadjuvant Treatment Modalities for Esophageal Cancer

Overview

Esophageal cancer is the most prevalent cancer globally with poor survival outcome. The prognosis with surgery alone is poor, accounting for 30-40% of overall survival at 5 year. Either neoadjuvant chemotherapy (nCT) or chemoradiotherapy (nCRT) has been shown as efficatious therapy to improve patients outcomes in esophageal or esophagogastric junction cancer as compared with surgery alone. The purpose of this study was to explore the optimal neoadjuvant treatment modalities including PD-1/PD-L1 antibody or targeted drug for patients with esophageal or esophagogastric junction cancer.

Interventions

  • Drug Platinum based chemotherapy
    q1-3W according to physician's preference
  • Drug Paclitaxel based chemotherapy
    q1-3W according to physician's preference
  • Radiation Radiotherpay
    40-50Gy/1.8-2.2Gy/20-25f
  • Procedure Surgery
    Radical esophagectomy
  • Drug Immunotherapy
    Anti-PD-1/PD-L1 Antibody
  • Drug 5-FU Analog based chemotherpay
    W1-5 qW or d1-14, q3W according to physician's preference
  • Drug Nimotuzumab
    200-400mg, d1,qW

Primary outcome measures

  • Overall survival [Time frame: 5 year]
Secondary outcome measures (6)
  • Progression free survival [Time frame: 1 year, 2 year, 3 year, 5 year]
  • Number of participants with Acute and late toxicities of radiotherapy,chemotherapy and immunotherapy [Time frame: 3 months]
  • Pathological response rate [Time frame: 3 months]
  • R0 resection rate [Time frame: 3 months]
  • Locoregional recurrence free survival [Time frame: 1 year, 2 year, 3 year, 5 year]
  • Distant metastasis free survival [Time frame: 1 year, 2 year, 3 year, 5 year]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Department of Radiation Oncology, National Cancer Center/National Clinical Research Center — Beijing

Identifiers

NCT: NCT04821843 · NCC2721

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗