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

Completed

• Conditions: Metastatic Esophageal Squamous Cell Carcinoma
• Interventions: Drug: Chemotherapy combined with immunotherapy; Radiation: radiotherapy

• Registration Number: NCT06190652
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

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.

Study Timeline

• Study Start: 2018-10-13
• Status Verified: 2023-12
• Primary Completion: 2023-12-04
• Study Completion: 2023-12-04
• Study First Submitted: 2023-12-19
• Study First Submitted QC: 2023-12-19
• Study First Posted: 2024-01-05
• Last Update Submitted: 2024-02-02
• Last Update Posted: 2024-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 728

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm A	Chemotherapy combined with immunotherapy	Chemotherapy combined with immunotherapy group
Arm B	radiotherapy	Chemotherapy combined with immunotherapy + radiotherapy group
Arm B	Chemotherapy combined with immunotherapy	Chemotherapy combined with immunotherapy + radiotherapy group

Primary Outcome Measures

Name	Time	Method
PFS	up to 2 years	progression-free survival

Secondary Outcome Measures

Name	Time	Method
ORR	up to 2 years	Objective Response Rate
RP	up to 2 years	recurrence recurrence pattern
OS	up to 2 years	overall Survival
DoR	up to 2 years	Duration of ResponseR

Trial Locations

Locations (5)

Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China

Shanxi Cancer Hospital; 🇨🇳 Taiyuan, Shanxi, China

Hunan Cancer Hospital; 🇨🇳 Changsha, Hunan, China

Tianjin Cancer Hospital; 🇨🇳 Tianjin, Tianjin, China

Sichuan Cancer Hospital; 🇨🇳 Chengdu, Sichuan, China