Clinical trial NCT06190652: Real-world Experience of ICIs Plus Chemotherapy With or Without Radiotherapy for Advanced ESCC.
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Esophageal Squamous Cell Carcinoma
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
Collaborators: name: Sichuan Cancer Hospital and Research Institute
name: Henan Cancer Hospital
name: Shanxi Province Cancer Hospital
name: Hunan Cancer Hospital
name: The First Affiliated Hospital with Nanjing Medical University
name: Hebei Medical University Fourth Hospital
First posted: 2024-01-05
Enrollment: 728
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. The clinical stage is IVb stage, that is, non-regional lymph node metastasis and distant organ metastasis (AJCC8th) of esophageal carcinoma.
2. Patients who had received at least one cycle of first-line chemotherapy combined with immunotherapy, received or did not receive radiotherapy;
3. Pathologically diagnosed as 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.

Eligibility criteria: 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

Primary outcomes:
measure: PFS
timeFrame: up to 2 years
Secondary outcomes:
measure: OS
timeFrame: up to 2 years
measure: DoR
timeFrame: up to 2 years
measure: ORR
timeFrame: up to 2 years
measure: RP
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Taiyuan
country: China
facility: Shanxi Cancer Hospital
state: Shanxi
city: Chengdu
country: China
facility: Sichuan Cancer Hospital
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Cancer Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Wencheng Zhang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: