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

NCT06190652 | Completed

• 1 other identifier: bc2023043
• Study Type: observational
• Target: 728
• Locations: 1 country
• Sites: 5

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.

Conditions

Metastatic Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• PFS

  progression-free survival

  up to 2 years

Secondary Outcomes (4)

• OS

  up to 2 years

• DoR

  up to 2 years

• ORR

  up to 2 years

• RP

  up to 2 years

Study Arms (2)

Arm A

Chemotherapy combined with immunotherapy group

Drug: Chemotherapy combined with immunotherapy

Arm B

Chemotherapy combined with immunotherapy + radiotherapy group

Drug: Chemotherapy combined with immunotherapy; Radiation: radiotherapy

Interventions

Chemotherapy combined with immunotherapy DRUG

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

Arm A; Arm B

radiotherapy RADIATION

Intensity-modulated radiation therapy

Arm B

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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;

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead
• Sichuan Cancer Hospital and Research Institute: collaborator
• Henan Cancer Hospital: collaborator
• Shanxi Province Cancer Hospital: collaborator
• Hunan Cancer Hospital: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Hebei Medical University Fourth Hospital: collaborator

Study Sites (5)

Henan Cancer Hospital

Zhengzhou, Henan, China

Location

Hunan Cancer Hospital

Changsha, Hunan, China

Location

Shanxi Cancer Hospital

Taiyuan, Shanxi, China

Location

Sichuan Cancer Hospital

Chengdu, Sichuan, China

Location

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Immunotherapy; Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics

Study Officials

• Wencheng Zhang, M.D.

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 5, 2024
• Study Start: October 13, 2018
• Primary Completion: December 4, 2023
• Study Completion: December 4, 2023
• Last Updated: February 5, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)