Metastatic Esophageal Squamous Cell CarcinomaREICRAENCT06190652
Real-world Experience of ICIs Plus Chemotherapy With or Without Radiotherapy for Advanced ESCC.
An observational study of Metastatic Esophageal Squamous Cell Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 5 sites in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Metastatic Esophageal Squamous Cell Carcinoma
- What is being tested?
- Chemotherapy combined with immunotherapy and radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 728 participants
- Where
- 5 sitesChina
- Study dates
- 13 Oct 2018to 4 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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;
Who may be able to join
- 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;
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Hunan Cancer Hospital
Changsha, Hunan
Sichuan Cancer Hospital
Chengdu, Sichuan
Shanxi Cancer Hospital
Taiyuan, Shanxi
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300060
Henan Cancer Hospital
Zhengzhou, Henan
About this study
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
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.
- Being tested
- Chemotherapy combined with immunotherapy, radiotherapy
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemotherapy combined with immunotherapyDrug
chemotherapy：paclitaxel+platinum-based anticancer drugs immunotherapy：anti-PD-1 Immune checkpoint inhibitors
radiotherapyRadiation
Intensity-modulated radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Chemotherapy combined with immunotherapy group Receives: Drug: Chemotherapy combined with immunotherapy | |
| Arm B | Chemotherapy combined with immunotherapy + radiotherapy group Receives: Drug: Chemotherapy combined with immunotherapy; Radiation: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
progression-free survival
Measured: up to 2 years
Secondary outcomes (4)
OS
overall Survival
Measured: up to 2 years
DoR
Duration of ResponseR
Measured: up to 2 years
ORR
Objective Response Rate
Measured: up to 2 years
RP
recurrence recurrence pattern
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start13 Oct 2018
- Primary completion4 Dec 2023
- Study completion4 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 728 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- 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
- Investigators
- Wencheng Zhang, M.D., Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06190652
- Sponsor's protocol ID
- bc2023043
- Acronym
- REICRAE
- Status last verified
- Dec 2023
- First submitted
- 19 Dec 2023
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06190652
- Acronym / sponsor ID
- REICRAE / bc2023043
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 728 participants (actual)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- 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
- Study start
- 13 Oct 2018 (actual)
- Primary completion
- 4 Dec 2023 (actual)
- Study completion
- 4 Dec 2023 (actual)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | – | Drug: Chemotherapy combined with immunotherapyChemotherapy combined with immunotherapy group |
| Arm B | – | Drug: Chemotherapy combined with immunotherapy, Radiation: radiotherapyChemotherapy combined with immunotherapy + radiotherapy group |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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;
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chemotherapy combined with immunotherapychemotherapy：paclitaxel+platinum-based anticancer drugs immunotherapy：anti-PD-1 Immune checkpoint inhibitors | Drug | Arm A, Arm B |
| radiotherapyIntensity-modulated radiation therapy | Radiation | Arm B |
Primary outcome
PFS
Time frame: up to 2 years
progression-free survival
4 secondary outcomes
OS
Time frame: up to 2 years
DoR
Time frame: up to 2 years
ORR
Time frame: up to 2 years
RP
Time frame: up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wencheng Zhang, M.D. principal investigator
Tianjin Medical University Cancer Institute and Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Esophageal Squamous Cell Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.