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

Metastatic Esophageal Squamous Cell Carcinoma Clinical Trial

— REICRAE  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06190652
• Other study ID #: bc2023043
• Status: Completed
• Start date: October 13, 2018
• Est. completion date: December 4, 2023

Study information

• Verified date: December 2023
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 728
• Est. completion date: December 4, 2023
• Est. primary completion date: December 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma
• Metastatic Esophageal Squamous Cell Carcinoma

Intervention

Drug:
• Chemotherapy combined with immunotherapy
chemotherapy:paclitaxel+platinum-based anticancer drugs immunotherapy:anti-PD-1 Immune checkpoint inhibitors

Radiation:
• radiotherapy
Intensity-modulated radiation therapy

Locations

Country	Name	City	State
China	Hunan Cancer Hospital	Changsha	Hunan
China	Sichuan Cancer Hospital	Chengdu	Sichuan
China	Shanxi Cancer Hospital	Taiyuan	Shanxi
China	Tianjin Cancer Hospital	Tianjin	Tianjin
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (7)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and 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, The Fourth Hospital of Hebei Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	progression-free survival	up to 2 years
Secondary	OS	overall Survival	up to 2 years
Secondary	DoR	Duration of ResponseR	up to 2 years
Secondary	ORR	Objective Response Rate	up to 2 years
Secondary	RP	recurrence recurrence pattern	up to 2 years