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CompletedNCT06190652REICRAEUpdated Feb 5, 2024

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

An observational study in Metastatic Esophageal Squamous Cell Carcinoma, sponsored by Tianjin Medical University Cancer Institute and Hospital. Completed at 5 sites in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-02-05.

Sponsored by Tianjin Medical University Cancer Institute and Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
728
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Metastatic Esophageal Squamous Cell Carcinoma
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In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 728 is above the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital is the lead sponsor of 484 studies on the registry; 286 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
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;

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

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
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
728 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • DrugChemotherapy combined with immunotherapy

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

  • Radiationradiotherapy

    Intensity-modulated radiation therapy

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What researchers measure

Primary outcomes

  1. PFS

    progression-free survival

    Time frame: up to 2 years

Secondary outcomes

  1. OS

    overall Survival

    Time frame: up to 2 years

  2. DoR

    Duration of ResponseR

    Time frame: up to 2 years

  3. ORR

    Objective Response Rate

    Time frame: up to 2 years

  4. RP

    recurrence recurrence pattern

    Time frame: up to 2 years

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Study locations

5 sites
  • Henan Cancer Hospital
    Zhengzhou, Henan, China
  • Hunan Cancer Hospital
    Changsha, Hunan, China
  • Shanxi Cancer Hospital
    Taiyuan, Shanxi, China
  • Sichuan Cancer Hospital
    Chengdu, Sichuan, China
  • Tianjin Cancer Hospital
    Tianjin, Tianjin 300060, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06190652
Lead sponsor
Tianjin Medical University Cancer Institute and Hospital
Collaborators
Sichuan Cancer Hospital and Research Institute, Henan Cancer Hospital, Shanxi Province Cancer Hospital, Hunan Cancer Hospital, The First Affiliated Hospital with Nanjing Medical University, Hebei Medical University Fourth Hospital
Responsible party
Sponsor
First posted
Jan 5, 2024
Start date
Oct 13, 2018
Primary completion
Dec 4, 2023
Completion
Dec 4, 2023
Last update
Feb 5, 2024

Study contacts

Wencheng Zhang, M.D.
principal investigator · Tianjin Medical University Cancer Institute and Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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