Esophageal Squamous Cell CarcinomaNCT06602843
Neoadjuvant Chemoimmunotherapy Followed by Surgery and Postoperative Radioimmunotherapy
A study testing Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy in people with Esophageal Squamous Cell Carcinoma, run by Anhui Provincial Hospital at 1 site in China.
Trial summary
The goal of this study was to explore the efficacy and safety of neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy in patients with locally advanced esophageal squamous cell carcinoma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18-75;
- Radical operation for esophageal cancer;
- Esophageal squamous cell carcinoma was confirmed by postoperative pathology; . Preoperative imaging (enhanced cervical, thoracoabdominal CT+ bone scan) and postoperative pathological evaluation were performed, and the stage was pIIB-IVA (AJCC eighth edition staging criteria: T≥3 or N+).
- More than or equal to 12 lymph nodes were surgically removed;
- Postoperative ECOG score 0-1, able to tolerate postoperative adjuvant radiotherapy and immunotherapy;
- Informed consent signed by patient or family member.
Who cannot join
- Less than 18 years old, more than 75 years old;
- did not receive radical resection of esophageal cancer, including palliative resection;
- Postoperative pathology showed non-esophageal squamous cell carcinoma;
- After preoperative imaging (enhanced cervical, thoracoabdominal CT+ bone scan) and postoperative pathological evaluation, the stage was pI, IIA, IVB (AJCC eighth edition staging standard); e. Less than 12 lymph nodes were surgically removed;
- Postoperative ECOG score 2-3 points, unable to tolerate postoperative adjuvant radiotherapy and immunotherapy;
- The patient or family member did not sign the informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Anhui provincial hospital
Hefei
Yuan He, +8618926243766, heyuan3766@126.com
About this study
Official title: Neoadjuvant Chemoimmunotherapy Followed by Surgery and Postoperative Radioimmunotherapy in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma
The goal of this study was to explore the efficacy and safety of neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy in patients with locally advanced esophageal squamous cell carcinoma
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy
- Keywords
- Esophageal Squamous Cell Carcinoma, Locally advanced, Chemoimmunotherapy, Radioimmunotherapy
- 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.
Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapyProcedure or surgery
Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy Receives: Procedure: Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy |
| Comparator | Active comparator | chemoradiotherapy followed by surgery Receives: Procedure: Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR
Pathologic Complete Response
Measured: immediately after the intervention/procedure/surgery
Secondary outcomes (1)
R0 resection rate
R0 resection rate
Measured: immediately after the intervention/procedure/surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Anhui Provincial 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06602843
- Sponsor's protocol ID
- 2024-042
- Status last verified
- Jan 2024
- First submitted
- 8 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Chemoimmunotherapy Followed by Surgery and Postoperative Radioimmunotherapy in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06602843
- Acronym / sponsor ID
- 2024-042
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- Esophageal Squamous Cell Carcinoma, Locally advanced, Chemoimmunotherapy, Radioimmunotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Sep 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.
The goal of this study was to explore the efficacy and safety of neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy in patients with locally advanced esophageal squamous cell carcinoma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Procedure: Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapyNeoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy |
| Comparator | Active comparator | Procedure: Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapychemoradiotherapy followed by surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ages 18-75;
- Radical operation for esophageal cancer;
- Esophageal squamous cell carcinoma was confirmed by postoperative pathology; . Preoperative imaging (enhanced cervical, thoracoabdominal CT+ bone scan) and postoperative pathological evaluation were performed, and the stage was pIIB-IVA (AJCC eighth edition staging criteria: T≥3 or N+).
- More than or equal to 12 lymph nodes were surgically removed;
- Postoperative ECOG score 0-1, able to tolerate postoperative adjuvant radiotherapy and immunotherapy;
Key exclusion criteria (6 listed)
- Less than 18 years old, more than 75 years old;
- did not receive radical resection of esophageal cancer, including palliative resection;
- Postoperative pathology showed non-esophageal squamous cell carcinoma;
- After preoperative imaging (enhanced cervical, thoracoabdominal CT+ bone scan) and postoperative pathological evaluation, the stage was pI, IIA, IVB (AJCC eighth edition staging standard); e. Less than 12 lymph nodes were surgically removed;
- Postoperative ECOG score 2-3 points, unable to tolerate postoperative adjuvant radiotherapy and immunotherapy;
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 |
|---|---|---|
| Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapyNeoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy | Procedure or surgery | Comparator, Experimental |
Primary outcome
pCR
Time frame: immediately after the intervention/procedure/surgery
Pathologic Complete Response
1 secondary outcome
R0 resection rate
Time frame: immediately after the intervention/procedure/surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy in people with Esophageal Squamous Cell Carcinoma, run by Anhui Provincial Hospital at 1 site 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 6 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: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR (time frame: immediately after the intervention/procedure/surgery). 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 19 Sep 2024.