Chemoradiotherapy in Esophageal or Esophagogastric Junction Cancer

August 17, 2022 updated by: Wang Xin, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Cohort Study of Definitive Chemoradiotherapy for Esophageal or Esophagogastric Junction Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

2000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100021
        • Recruiting
        • 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)
      • Changsha, China
        • Recruiting
        • Hunan Cancer Hospital, the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University
        • Contact:
      • Nanjing, China
        • Recruiting
        • Department of Radiation oncology, Jiangsu Cancer Hospital/Jiangsu Institute of Cancer Research/The affiliated Cancer Hospital of Nanjing Medical University
        • Contact:
          • Cheng Chen
    • Henan
      • Anyang, Henan, China
        • Recruiting
        • Department 4th of Radiation Oncology, Anyang Cancer Hospital
        • Contact:
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Department of Radiation oncology, Jiangsu Province Hospital/The First Affiliated Hospital with Nanjing Medical University
        • Contact:
        • Contact:
          • Xinchen Sun

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Definitive Chemoradiation
This arm received chemoradiation without immunotherapy/targeting agents as definitive treatment.
Radiation: Radiotherapy
50-66Gy/1.8-2.2Gy/25-30f
Drug: Platinum based chemotherapy
q1-3W according to physician's preference
Drug: Paclitaxel based chemotherapy
q1-3W according to physician's preference
Drug: 5-FU Analog based chemotherapy
W1-5 qW or d1-14, q3W according to physician's preference
Experimental: Chemoradiation Combined With Immunotherapy/targeting agents
This arm received chemoradiation with immunotherapy/targeting agents as definitive treatment.
Radiation: Radiotherapy
50-66Gy/1.8-2.2Gy/25-30f
Drug: Platinum based chemotherapy
q1-3W according to physician's preference
Drug: Paclitaxel based chemotherapy
q1-3W according to physician's preference
Drug: 5-FU Analog based chemotherapy
W1-5 qW or d1-14, q3W according to physician's preference
Drug: Immunotherapy
Anti-PD-1/PD-L1 Antibody
Drug: Nimotuzumab
200-400mg, d1,qW

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 5 year
5 year
Overall survival
Time Frame: 3 year
3 year
Overall survival
Time Frame: 2 year
2 year
Overall survival
Time Frame: 1year
1year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: 1 year, 2 year, 3 year, 5 year
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
3 months
Pathological response rate
Time Frame: 3 months
Pathological response were classified into three grades.Grade I signifies that there is little shrinkage in the tumor; only mild regression in the tumor cells is observed under themicroscope. Grade II shows gross reduction in size of the tumor and marked regression in the cancer cells microscopically, yet viable nests of cancer tissue are still visible. Grade III implies complete or almost total resolution of the tumor on exploration, and disappearance of the tumor tissue microscopically; only remnants of degenerated cancer cells can be seen (so-called ghost cancer cells).
3 months
R0 resection rate
Time Frame: 3 months
3 months
Locoregional recurrence free survival
Time Frame: 1 year, 2 year, 3 year, 5 year
1 year, 2 year, 3 year, 5 year
Distant metastasis free survival
Time Frame: 1 year, 2 year, 3 year, 5 year
1 year, 2 year, 3 year, 5 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 1 year, 2 year, 3 year, 5 year
1 year, 2 year, 3 year, 5 year
Radiomics analysis
Time Frame: 1 year, 2 year, 3 year, 5 year
Analysis of correlation between radiomics signature extracted by LASSO and the rate of participants who achieve pathological complete response (pCR) and the overall survival based on MRI and CT simulation.
1 year, 2 year, 3 year, 5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2002

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

March 15, 2021

First Submitted That Met QC Criteria

March 26, 2021

First Posted (Actual)

March 30, 2021

Study Record Updates

Last Update Posted (Actual)

August 22, 2022

Last Update Submitted That Met QC Criteria

August 17, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC2722

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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