Neoadjuvant Treatment Modalities in Esophageal Cancer

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

About this trial

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.

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

  • Platinum based chemotherapy

    Drug

    q1-3W according to physician's preference

  • Paclitaxel based chemotherapy

    Drug

    q1-3W according to physician's preference

  • Radiotherpay

    Radiation

    40-50Gy/1.8-2.2Gy/20-25f

  • Surgery

    Procedure/Surgery

    Radical esophagectomy

  • Immunotherapy

    Drug

    Anti-PD-1/PD-L1 Antibody

  • 5-FU Analog based chemotherpay

    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: (Neoadjuvant chemotherapy) nCTExperimental treatment 7 interventions
Group B: (Neoadjuvant Chemoradiation) nCRTPlacebo comparator 6 interventions

Trial outcomes

Primary outcomes

1

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

Acute and late toxicities are evaluated by NCI-CTC version 5.0

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 the correlation between radiation dose 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

The value of Radiomics of MRI and CT in predicting pathological complete response (pCR) or no response (NR) and the correlation between radiomics of MRI and CT and overall survival (OS), which is defined as the time from the beginning of neoadjuvant chemotherapy to the death with any causes.

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

Click on the lead sponsor to view all of their trials.