Esophageal Squamous Cell Carcinoma (ESCC)NCT07236320
Neoadjuvant Immunochemotherapy vs Chemoradiotherapy in ESCC
A study testing Neoadjuvant immunochemotherapy and Neoadjuvant Chemoradiotherapy in people with Esophageal Squamous Cell Carcinoma (ESCC), run by Yongtao Han at 1 site in China.
Trial summary
This retrospective real-world study aimed to compare neoadjuvant immunochemotherapy (NICT) and neoadjuvant chemoradiotherapy (NCRT) followed by esophagectomy in patients with locally advanced esophageal squamous cell carcinoma (ESCC). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma (ESCC)
- What is being tested?
- Neoadjuvant immunochemotherapy and Neoadjuvant Chemoradiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2018to 28 Feb 2025
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years
- Histologically confirmed thoracic ESCC
- Clinical stage cT1N+M0 or cT2-4aN0-3M0
- Received neoadjuvant therapy (immunochemotherapy or chemoradiotherapy) followed by esophagectomy
Who cannot join
- History of other malignancies
- Did not complete neoadjuvant therapy or required salvage surgery
- Incomplete baseline or follow-up data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neoadjuvant Immunochemotherapy Versus Chemoradiotherapy in Locally Advanced Esophageal Cancer: A Real-World Study
This retrospective real-world study aimed to compare neoadjuvant immunochemotherapy (NICT) and neoadjuvant chemoradiotherapy (NCRT) followed by esophagectomy in patients with locally advanced esophageal squamous cell carcinoma (ESCC). A total of 203 consecutive patients treated at Sichuan Cancer Hospital between March 2018 and March 2022 were analyzed (NICT: 59; NCRT: 144). The primary endpoints were overall survival (OS) and disease-free survival (DFS); secondary endpoints included pathological complete response (pCR), tumor regression grade (TRG), and R0 resection rate. After inverse probability of treatment weighting adjustment, baseline characteristics were balanced between groups. Both groups achieved comparable long-term OS and DFS, while NCRT showed higher rates of local pathological response. Exploratory subgroup analysis suggested that patients achieving pCR after NICT might have superior survival outcomes. The study indicates that NICT provides similar long-term survival compared to NCRT and may offer immunologic advantages for selected responders, warranting further validation in prospective multicenter trials.
- Being tested
- Neoadjuvant immunochemotherapy, Neoadjuvant Chemoradiotherapy
- 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 immunochemotherapyDrug
NACI group patients received treatment of minimally 2 cycles of ICIs agent (mainly camrelizumab or toripalimab, 200 mg every 3 weeks (200 mg every 3 weeks)) combined with concurrent chemotherapy.
Neoadjuvant ChemoradiotherapyDrug
NCRT group patients followed the concurrent NCRT treatment, and the total neoadjuvant radiotherapy dose was 40.0-50.4Gy with 1.8-2.14 Gy fractions and 5 fractions/week.
| Study group | Role | What they receive |
|---|---|---|
| NICT group | Experimental | Not described Receives: Drug: Neoadjuvant immunochemotherapy |
| NCRT group | Active comparator | Not described Receives: Drug: Neoadjuvant Chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Time from first treatment to death from any cause or last follow-up.
Measured: 5 years
Disease-Free Survival (DFS)
Time from surgery to recurrence, death, or last follow-up.
Measured: 5 years
Secondary outcomes (3)
Pathological Complete Response (pCR) rate
Measured: 3 months
Tumor Regression Grade (TRG)
Measured: 3 months
R0 resection rate
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start1 Mar 2018
- Primary completion31 Mar 2022
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell Carcinoma (ESCC)Studies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yongtao Han
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yongtao Han, Sichuan Cancer Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236320
- Sponsor's protocol ID
- SCCH-TS2503
- Status last verified
- Nov 2025
- First submitted
- 15 Nov 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data (IPD) will not be shared because this is a retrospective study based on patient medical records, and the data contain potentially identifiable clinical information. Ethical approval for this study was granted under the condition that data would be used only for internal analysis at Sichuan Cancer Hospital \& Institute. De-identified summary-level results are provided within the publication.
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Immunochemotherapy Versus Chemoradiotherapy in Locally Advanced Esophageal Cancer: A Real-World Study
- ClinicalTrials.gov ID
- NCT07236320
- Acronym / sponsor ID
- SCCH-TS2503
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Yongtao HanUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 19 Nov 2025 (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 retrospective real-world study aimed to compare neoadjuvant immunochemotherapy (NICT) and neoadjuvant chemoradiotherapy (NCRT) followed by esophagectomy in patients with locally advanced esophageal squamous cell carcinoma (ESCC). A total of 203 consecutive patients treated at Sichuan Cancer Hospital between March 2018 and March 2022 were analyzed (NICT: 59; NCRT: 144). The primary endpoints were overall survival (OS) and disease-free survival (DFS); secondary endpoints included pathological complete response (pCR), tumor regression grade (TRG), and R0 resection rate. After inverse probability of treatment weighting adjustment, baseline characteristics were balanced between groups. Both groups achieved comparable long-term OS and DFS, while NCRT showed higher rates of local pathological response. Exploratory subgroup analysis suggested that patients achieving pCR after NICT might have superior survival outcomes. The study indicates that NICT provides similar long-term survival compared to NCRT and may offer immunologic advantages for selected responders, warranting further validation in prospective multicenter trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NICT group | Experimental | Drug: Neoadjuvant immunochemotherapy |
| NCRT group | Active comparator | Drug: Neoadjuvant Chemoradiotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-80 years
- Histologically confirmed thoracic ESCC
- Clinical stage cT1N+M0 or cT2-4aN0-3M0
- Received neoadjuvant therapy (immunochemotherapy or chemoradiotherapy) followed by esophagectomy
Key exclusion criteria (3 listed)
- History of other malignancies
- Did not complete neoadjuvant therapy or required salvage surgery
- Incomplete baseline or follow-up data
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 immunochemotherapyNACI group patients received treatment of minimally 2 cycles of ICIs agent (mainly camrelizumab or toripalimab, 200 mg every 3 weeks (200 mg every 3 weeks)) combined with concurrent chemotherapy. | Drug | NICT group |
| Neoadjuvant ChemoradiotherapyNCRT group patients followed the concurrent NCRT treatment, and the total neoadjuvant radiotherapy dose was 40.0-50.4Gy with 1.8-2.14 Gy fractions and 5 fractions/week. | Drug | NCRT group |
Primary outcome
Overall Survival (OS)
Time frame: 5 years
Time from first treatment to death from any cause or last follow-up.
Disease-Free Survival (DFS)
Time frame: 5 years
Time from surgery to recurrence, death, or last follow-up.
3 secondary outcomes
Pathological Complete Response (pCR) rate
Time frame: 3 months
Tumor Regression Grade (TRG)
Time frame: 3 months
R0 resection rate
Time frame: 3 months
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 19 Nov 2025.
- Individual participant dataSharing planned: Undecided. Individual participant data (IPD) will not be shared because this is a retrospective study based on patient medical records, and the data contain potentially identifiable clinical information. Ethical approval for this study was granted under the condition that data would be used only for internal analysis at Sichuan Cancer Hospital \& Institute. De-identified summary-level results are provided within the publication.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 immunochemotherapy and Neoadjuvant Chemoradiotherapy in people with Esophageal Squamous Cell Carcinoma (ESCC), run by Yongtao Han 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 4 inclusion and 3 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 19 Nov 2025. 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?
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?
Overall Survival (OS) (time frame: 5 years). The study lists 2 primary outcomes in all. 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 Nov 2025.