Chemoradiotherapy in Esophageal or Esophagogastric Junction Cancer

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

≥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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Radiotherapy

    Radiation

    50-66Gy/1.8-2.2Gy/25-30f

  • Platinum based chemotherapy

    Drug

    q1-3W according to physician's preference

  • Paclitaxel based chemotherapy

    Drug

    q1-3W according to physician's preference

  • Immunotherapy

    Drug

    Anti-PD-1/PD-L1 Antibody

  • 5-FU Analog based chemotherapy

    Drug

    W1-5 qW or d1-14, q3W according to physician's preference

  • Nimotuzumab

    Drug

    200-400mg, d1,qW

Treatment groups

2,000 Participants
are divided into 2 treatment groups
Group A: Definitive ChemoradiationPlacebo comparator 4 interventions
Group B: Chemoradiation Combined With Immunotherapy/targeting agentsExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Overall survival

Time frame
1year
2

Overall survival

Time frame
2 year
3

Overall survival

Time frame
3 year
4

Overall survival

Time frame
5 year

Secondary outcomes

1

Progression free survival

Time frame
1 year, 2 year, 3 year, 5 year
2

Number of participants with Acute and late toxicities of radiotherapy,chemotherapy and immunotherapy

Time frame
3 months
3

Pathological response rate

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).

Time frame
3 months
4

R0 resection rate

Time frame
3 months

Other outcomes

1

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
2

Radiomics analysis

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.

Time frame
1 year, 2 year, 3 year, 5 year
3

Target dealineation of organs at risk and their impact on the prognosis and adverse effects of radiotherapy

Time frame
1 year, 2 year, 3 year, 5 year
4

Target dealineation of clinical target volumn and their impact on the prognosis

Time frame
1 year, 2 year, 3 year, 5 year

Sponsors and contacts

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