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

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

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.

Study Overview

• Status: Completed
• Conditions: Metastatic Esophageal Squamous Cell Carcinoma
• Intervention / Treatment: Drug: Chemotherapy combined with immunotherapy; Radiation: radiotherapy

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 Type: Observational
• Enrollment (Actual): 728

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China
      • Henan Cancer Hospital
  • Hunan
    • Changsha, Hunan, China
      • Hunan Cancer Hospital
  • Shanxi
    • Taiyuan, Shanxi, China
      • Shanxi Cancer Hospital
  • Sichuan
    • Chengdu, Sichuan, China
      • Sichuan Cancer Hospital
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Tianjin Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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;

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Arm A; Chemotherapy combined with immunotherapy group	Drug: Chemotherapy combined with immunotherapy; chemotherapy：paclitaxel+platinum-based anticancer drugs immunotherapy：anti-PD-1 Immune checkpoint inhibitors
Arm B; Chemotherapy combined with immunotherapy + radiotherapy group	Drug: Chemotherapy combined with immunotherapy; chemotherapy：paclitaxel+platinum-based anticancer drugs immunotherapy：anti-PD-1 Immune checkpoint inhibitors; Radiation: radiotherapy; Intensity-modulated radiation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	progression-free survival	up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	Objective Response Rate	up to 2 years
DoR	Duration of ResponseR	up to 2 years
RP	recurrence recurrence pattern	up to 2 years
OS	overall Survival	up to 2 years

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Collaborators: The First Affiliated Hospital with Nanjing Medical University; Shanxi Province Cancer Hospital; Henan Cancer Hospital; Hunan Cancer Hospital; The Fourth Hospital of Hebei Medical University; Sichuan Cancer Hospital and Research Institute
• Investigators: Principal Investigator: Wencheng Zhang, M.D., Tianjin Medical University Cancer Institute & Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2018
• Primary Completion (Actual): December 4, 2023
• Study Completion (Actual): December 4, 2023

Study Registration Dates

• First Submitted: December 19, 2023
• First Submitted That Met QC Criteria: December 19, 2023
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Estimated): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Neoplasms, Squamous Cell; Esophageal Neoplasms; Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma; Physiological Effects of Drugs; Immunologic Factors; Immunomodulating Agents
• Other Study ID Numbers: bc2023043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No