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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06190652

Acronym

REICRAE

Enrollment

728

Registered

2024-01-05

Start date

2018-10-13

Completion date

2023-12-04

Last updated

2024-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Esophageal Squamous Cell Carcinoma

Brief summary

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.

Detailed description

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.

Interventions

DRUGChemotherapy combined with immunotherapy

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

RADIATIONradiotherapy

Intensity-modulated radiation therapy

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

1. Pathologically diagnosed as esophageal squamous cell carcinoma; 2. The clinical stage is IVb stage, that is, non-regional lymph node metastasis and distant organ metastasis (AJCC8th) of esophageal carcinoma. 3. Patients had received no previous systemic therapy 4. Patients who had received at least one cycle of first-line chemotherapy combined with immunotherapy, received or did not receive radiotherapy; 5. Complete medical records; 6. ECOG0-2;

Exclusion criteria

1. Surgery for esophageal cancer; 2. Esophageal fistulae due to infiltration of the primary tumour. 3. Risk of gastrointestinal bleeding, oesophageal fistula or oesophageal perforation 4. Those who have a history of autoimmune disease or have been treated with immunosuppressants within the last 3 months. 5. Those who have received organ transplant surgery. 6. 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). 7. There are other serious diseases, such as myocardial infarction, cerebral infarction or severe cardiopulmonary insufficiency within 6 months

Design outcomes

Primary

Measure	Time frame	Description
PFS	up to 2 years	progression-free survival

Secondary

Measure	Time frame	Description
OS	up to 2 years	overall Survival
DoR	up to 2 years	Duration of ResponseR
ORR	up to 2 years	Objective Response Rate
RP	up to 2 years	recurrence recurrence pattern

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026