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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

728 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-13

Study Completion Date

2023-12-04

Brief Summary

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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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Detailed Description

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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.

Conditions

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Metastatic Esophageal Squamous Cell Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Arm A

Chemotherapy combined with immunotherapy group

Chemotherapy combined with immunotherapy

Intervention Type DRUG

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

Arm B

Chemotherapy combined with immunotherapy + radiotherapy group

Chemotherapy combined with immunotherapy

Intervention Type DRUG

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

radiotherapy

Intervention Type RADIATION

Intensity-modulated radiation therapy

Interventions

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Chemotherapy combined with immunotherapy

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

Intervention Type DRUG

radiotherapy

Intensity-modulated radiation therapy

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No