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OpenTrials
Completed

NCT Number: NCT06190652

Real-world Experience of ICIs Plus Chemotherapy With or Without Radiotherapy for Advanced ESCC.

This study is a multi-center, non-interventional study. Clinicopathologic, treatment , outcome and efficacy data will be collected from medical records in metastatic esophageal squamous cell carcinoma (ESCC) patients.

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Key information

About this study

This study is a multi-center, non-interventional study. Patients' background, treatment pattern, treatment outcome, efficacy will be collected in metastatic esophageal squamous cell carcinoma (ESCC) patients who were treated with chemotherapy combined with immunotherapy as 1st line treatment at approximately 5 institutions. The patients should have received at least 1 cycle of immunotherapy and chemotherapy with or without radiotherapy. Based on these data, overall survival (OS), progression free survival (PFS) from start of 1st line treatment and the role and efficacy of radiotherapy for these patients will be assessed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pathologically diagnosed as esophageal squamous cell carcinoma;
  • The clinical stage is IVb stage, that is, non-regional lymph node metastasis and distant organ metastasis (AJCC8th) of esophageal carcinoma.
  • Patients had received no previous systemic therapy
  • Patients who had received at least one cycle of first-line chemotherapy combined with immunotherapy, received or did not receive radiotherapy;
  • Complete medical records;
  • ECOG0-2;

Exclusion criteria

  • Surgery for esophageal cancer;
  • Esophageal fistulae due to infiltration of the primary tumour.
  • Risk of gastrointestinal bleeding, oesophageal fistula or oesophageal perforation
  • Those who have a history of autoimmune disease or have been treated with immunosuppressants within the last 3 months.
  • Those who have received organ transplant surgery.
  • Patients with a previous history of malignant tumor (skin basal cell carcinoma and cervical carcinoma in situ) survived tumor-free for 3 years after treatment.

Except for the above).

  • There are other serious diseases, such as myocardial infarction, cerebral infarction or severe cardiopulmonary insufficiency within 6 months

Treatment and study plan

Chemotherapy combined with immunotherapy

Drug

chemotherapy:paclitaxel+platinum-based anticancer drugs immunotherapy:anti-PD-1 Immune checkpoint inhibitors

Radiotherapy

Radiation

Intensity-modulated radiation therapy

Primary outcomes

  1. PFS

    Time frame: up to 2 years

    progression-free survival

Secondary outcomes

  1. OS

    Time frame: up to 2 years

    overall Survival

  2. DoR

    Time frame: up to 2 years

    Duration of ResponseR

  3. ORR

    Time frame: up to 2 years

    Objective Response Rate

  4. RP

    Time frame: up to 2 years

    recurrence recurrence pattern

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital

Other

Collaborators

  • Hebei Medical University Fourth Hospital
  • Henan Cancer Hospital
  • Hunan Cancer Hospital
  • Shanxi Province Cancer Hospital
  • Sichuan Cancer Hospital and Research Institute
  • The First Affiliated Hospital with Nanjing Medical University

Registry information

Official study title

Real-world Experience of Immunotherapy Plus Chemotherapy as First-line Treatment With or Without Radiotherapy for Patients With Advanced Oesophageal Squamous Cell Carcinoma in China

Acronym: REICRAE

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jan 5, 2024
Registry last updated
Feb 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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