Esophageal Squamous Cell CarcinomaPhase 2ESCCNCT06601309
Biomarker Based Neoadjuvant Strategies for Locally Advanced Resectable ESCC
A Phase 2 study testing Serplulimab, Paclitaxel+Cisplatin (Neoadjuvant Chemotherapy) and Paclitaxel+Cisplatin(Concurrent Chemoradiotherapy) in people with Esophageal Squamous Cell Carcinoma, run by Fujian Medical University Union Hospital at 1 site in China.
Trial summary
This study aims to evaluate the impact of the neoadjuvant treatment strategy based on CPS score on the pathological complete response (pCR) rate in patients with resectable locally advanced esophageal cancer. 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?
- Serplulimab, Paclitaxel+Cisplatin (Neoadjuvant Chemotherapy) and Paclitaxel+Cisplatin(Concurrent Chemoradiotherapy)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 11 Jul 2024to 31 Dec 2027
- Phase
- Phase 2
- 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
- Diagnosis: Histologically confirmed esophageal squamous cell carcinoma (ESCC).
- Stage: Resectable locally advanced ESCC (clinical stage II-III according to the AJCC/UICC 8th edition).
- Age: 18-75 years old.
- Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- PD-L1 Expression: Available PD-L1 expression level (CPS).
- Surgical Eligibility: Assessed as eligible for surgical resection by a thoracic surgeon.
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- Laboratory Requirements:
- Adequate bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L, Platelets ≥ 100 x 10^9/L, Hemoglobin ≥ 9 g/dL.
- Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), AST and ALT ≤ 2.5 x ULN.
- Adequate renal function: Serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 60 mL/min.
- Informed Consent: Ability to understand and willingness to sign a written informed consent document.
Who cannot join
- Distant Metastasis: Presence of distant metastasis.
- Other Malignancies: History of other malignancies within the past 5 years, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin carcinoma, or other localized non-invasive malignancy.
- Autoimmune Diseases: History of active autoimmune diseases requiring systemic treatment within the past 2 years.
- Infections: Active infection requiring systemic therapy.
- Uncontrolled Conditions: Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Previous Treatment: Previous treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies.
- Pregnancy and Lactation: Pregnant or breastfeeding women. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization.
- Allergies: Known allergy or hypersensitivity to study drugs or any excipient of these medications.
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
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Zhao-han Lin, 0086-0591-86218329, xhyyllwyh@163.com
About this study
Official title: Biomarker Based Neoadjuvant Strategies for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma: an Exploratory Phase II Single-arm Clinical Study
This study aims to evaluate the impact of the neoadjuvant treatment strategy based on CPS score on the pathological complete response (pCR) rate in patients with resectable locally advanced esophageal cancer.
Read the detailed description
Esophageal cancer is a malignant tumor with a high incidence in China, with most patients diagnosed at the advanced stage. Traditional treatment modalities include surgery, chemoradiotherapy, and chemotherapy. However, under current standard treatments, approximately 50% of patients remain incurable, primarily due to postoperative recurrence and distant metastasis. Therefore, seeking a new treatment strategy to improve efficacy is crucial.
This clinical trial aims to evaluate the use of immune checkpoint inhibitors in neoadjuvant therapy based on CPS scoring to enhance the pathologic complete response (pCR) rate. Patients pathologically confirmed with esophageal squamous cell carcinoma (ESCC) will undergo surgical assessment for operability. Eligible patients will further undergo CPS testing and will receive different neoadjuvant treatment strategies based on CPS results: patients with CPS ≥20 will receive neoadjuvant immunotherapy alone; CPS 10-20 patients will receive neoadjuvant chemotherapy followed by immunotherapy; and CPS <10 patients will receive standard neoadjuvant chemoradiotherapy.
After completing neoadjuvant therapy, patients will rest for 4-6 weeks before undergoing curative surgery, which will be reassessed by thoracic surgeons for R0 resection feasibility preoperatively. Postoperatively, pathological evaluation will assess the pCR rate and other secondary study endpoints, with the most severe toxicities included in the analysis.
This study anticipates a group-wide pCR rate of 45% based on a PD-L1 biomarker-guided neoadjuvant treatment strategy. The trial is designed to exclude a pCR rate of 30% or lower using a one-sided 95% confidence interval (α set at 0.025) and 80% statistical power, with a total sample size of 90. The null hypothesis will be rejected if fewer than 34 patients achieve pCR in the entire cohort.
Based on reference studies (EC-CRT-001, ESCORT-1, JUPITER-06, and KEYNOTE-590) and CPS distribution data for esophageal squamous cell carcinoma from our institution, it is expected that the proportions of patients with CPS ≥20, 10-20, and <10 will be 10%, 40%, and 50%, respectively, corresponding to 9, 36, and 45 eligible patients for each group. It is anticipated that biological specimens will be obtained from more than 30 patients.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- Serplulimab, Paclitaxel+Cisplatin (Neoadjuvant Chemotherapy), Paclitaxel+Cisplatin(Concurrent Chemoradiotherapy), Radiotherapy
- Keywords
- Esophageal Cancer, Neoadjuvant Therapy, Pathological Complete Response (pCR), Immunotherapy, Chemoradiotherapy, Biomarkers
- Medical subject headings
- Esophageal Squamous Cell Carcinoma, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SerplulimabDrug
Serplulimab (300 mg) administered intravenously on day 1 of each 21-day cycle for 2 cycles.
Paclitaxel+Cisplatin (Neoadjuvant Chemotherapy)Drug
Paclitaxel (175 mg/m²) and Cisplatin (75 mg/m²) administered intravenously on day 1 of each 21-day cycle for 2 cycles as part of neoadjuvant chemotherapy.
Paclitaxel+Cisplatin(Concurrent Chemoradiotherapy)Drug
Paclitaxel (50 mg/m²) and Cisplatin (25 mg/m²) administered intravenously on days 1, 8, 15, and 22 of a 4-week cycle as part of concurrent chemoradiotherapy.
RadiotherapyRadiation
Radiotherapy at a dose of 40 Gy, delivered in 20 fractions over 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| High PD-L1 Expression Group (CPS ≥ 20) | Experimental | Patients with high PD-L1 expression (CPS ≥ 20) will receive neoadjuvant immunotherapy alone. This treatment consists of serplulimab for 2 cycles. Receives: Drug: Serplulimab |
| Moderate PD-L1 Expression Group (CPS 10-20) | Experimental | Patients with moderate PD-L1 expression (CPS 10-20) will receive neoadjuvant chemotherapy combined with immunotherapy. This includes paclitaxel and cisplatin along with serplulimab for 2 cycles. Receives: Drug: Serplulimab; Drug: Paclitaxel+Cisplatin (Neoadjuvant Chemotherapy) |
| Low PD-L1 Expression Group (CPS < 10) | Experimental | Patients with low PD-L1 expression (CPS < 10) will receive standard neoadjuvant chemoradiotherapy. This includes paclitaxel and cisplatin along with radiotherapy (40 Gy in 20 fractions over 4 weeks). Receives: Drug: Paclitaxel+Cisplatin(Concurrent Chemoradiotherapy); Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR) Rate
The proportion of patients achieving a pathological complete response (pCR) after neoadjuvant treatment and surgical resection. pCR is defined as the absence of any residual invasive cancer in the resected esophagus and all sampled lymph nodes (ypT0N0) based on hematoxylin and eosin staining.
Measured: after the pathological examination of surgical speciments within 14 days after the operation
Secondary outcomes (7)
R0 Resection Rate
The proportion of patients achieving an R0 resection, defined as a microscopically margin-negative resection with no residual tumor at the resection margins.
Measured: after the pathological examination of surgical speciments ie within 14 days after the operation
Treatment-Related Toxicity
The incidence and severity of treatment-related adverse events, graded according to CTCAE 5.0. This includes adverse events related to Serplulimab, Paclitaxel, Cisplatin, and radiotherapy, as well as surgical complications.
Measured: From the start of treatment to 30 days post-surgery
3-Year Disease-Free Survival (DFS)
The percentage of patients who remain disease-free three years after surgical resection. DFS is defined as the time from R0 resection to the first occurrence of disease recurrence or death from any cause.
Measured: 36 months after treatment completion
Tumor Mutational Burden (TMB)
Tumor mutational burden (TMB) score as measured in tumor tissue samples.
Measured: 36 months after treatment completion.
Microsatellite Instability (MSI)
Percentage of patients with high microsatellite instability (MSI-H) in tumor tissue
Measured: 36 months after treatment completion
Circulating Tumor DNA (ctDNA)
Change in circulating tumor DNA (ctDNA) levels as measured by liquid biopsy.
Measured: 36 months after treatment completion
major pathological response
tumor regression ≥90%
Measured: Patients were evaluated 2 to 4 weeks postoperatively.
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 start11 Jul 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Dec 2027 (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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- This parallel assignment interventional study evaluates the efficacy and safety of biomarker-based neoadjuvant treatments in resectable locally advanced esophageal squamous cell carcinoma (ESCC). Patients are stratified by PD-L1 expression (CPS) into three groups: 1. High PD-L1 Expression (CPS ≥ 20) Neoadjuvant immunotherapy alone. 2. Moderate PD-L1 Expression (CPS 10-20): Neoadjuvant chemotherapy combined with immunotherapy. 3. Low PD-L1 Expression (CPS \< 10): Standard neoadjuvant chemoradiotherapy. All treatments are followed by surgical resection. The primary endpoint is the pathological complete response (pCR) rate post-surgery. Secondary endpoints include treatment-related toxicity, R0 resection rate, and 3-year disease-free survival (DFS). Exploratory endpoints include identifying molecular biomarkers linked to treatment efficacy.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong Yang, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06601309
- Sponsor's protocol ID
- BIONS-R
- Acronym
- ESCC
- Status last verified
- Oct 2026
- First submitted
- 10 Sep 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Based Neoadjuvant Strategies for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma: an Exploratory Phase II Single-arm Clinical Study
- ClinicalTrials.gov ID
- NCT06601309
- Acronym / sponsor ID
- ESCC / BIONS-R
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- Esophageal Cancer, Neoadjuvant Therapy, Pathological Complete Response (pCR), Immunotherapy, Chemoradiotherapy, Biomarkers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 11 Jul 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Dec 2027 (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.
This study aims to evaluate the impact of the neoadjuvant treatment strategy based on CPS score on the pathological complete response (pCR) rate in patients with resectable locally advanced esophageal cancer.
Detailed description
Esophageal cancer is a malignant tumor with a high incidence in China, with most patients diagnosed at the advanced stage. Traditional treatment modalities include surgery, chemoradiotherapy, and chemotherapy. However, under current standard treatments, approximately 50% of patients remain incurable, primarily due to postoperative recurrence and distant metastasis. Therefore, seeking a new treatment strategy to improve efficacy is crucial.
This clinical trial aims to evaluate the use of immune checkpoint inhibitors in neoadjuvant therapy based on CPS scoring to enhance the pathologic complete response (pCR) rate. Patients pathologically confirmed with esophageal squamous cell carcinoma (ESCC) will undergo surgical assessment for operability. Eligible patients will further undergo CPS testing and will receive different neoadjuvant treatment strategies based on CPS results: patients with CPS ≥20 will receive neoadjuvant immunotherapy alone; CPS 10-20 patients will receive neoadjuvant chemotherapy followed by immunotherapy; and CPS <10 patients will receive standard neoadjuvant chemoradiotherapy.
After completing neoadjuvant therapy, patients will rest for 4-6 weeks before undergoing curative surgery, which will be reassessed by thoracic surgeons for R0 resection feasibility preoperatively. Postoperatively, pathological evaluation will assess the pCR rate and other secondary study endpoints, with the most severe toxicities included in the analysis.
This study anticipates a group-wide pCR rate of 45% based on a PD-L1 biomarker-guided neoadjuvant treatment strategy. The trial is designed to exclude a pCR rate of 30% or lower using a one-sided 95% confidence interval (α set at 0.025) and 80% statistical power, with a total sample size of 90. The null hypothesis will be rejected if fewer than 34 patients achieve pCR in the entire cohort.
Based on reference studies (EC-CRT-001, ESCORT-1, JUPITER-06, and KEYNOTE-590) and CPS distribution data for esophageal squamous cell carcinoma from our institution, it is expected that the proportions of patients with CPS ≥20, 10-20, and <10 will be 10%, 40%, and 50%, respectively, corresponding to 9, 36, and 45 eligible patients for each group. It is anticipated that biological specimens will be obtained from more than 30 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This parallel assignment interventional study evaluates the efficacy and safety of biomarker-based neoadjuvant treatments in resectable locally advanced esophageal squamous cell carcinoma (ESCC). Patients are stratified by PD-L1 expression (CPS) into three groups: 1. High PD-L1 Expression (CPS ≥ 20) Neoadjuvant immunotherapy alone. 2. Moderate PD-L1 Expression (CPS 10-20): Neoadjuvant chemotherapy combined with immunotherapy. 3. Low PD-L1 Expression (CPS < 10): Standard neoadjuvant chemoradiotherapy. All treatments are followed by surgical resection. The primary endpoint is the pathological complete response (pCR) rate post-surgery. Secondary endpoints include treatment-related toxicity, R0 resection rate, and 3-year disease-free survival (DFS). Exploratory endpoints include identifying molecular biomarkers linked to treatment efficacy.
| Arm | Type | Receives |
|---|---|---|
| High PD-L1 Expression Group (CPS ≥ 20) | Experimental | Drug: SerplulimabPatients with high PD-L1 expression (CPS ≥ 20) will receive neoadjuvant immunotherapy alone. This treatment consists of serplulimab for 2 cycles. |
| Moderate PD-L1 Expression Group (CPS 10-20) | Experimental | Drug: Serplulimab, Drug: Paclitaxel+Cisplatin (Neoadjuvant Chemotherapy)Patients with moderate PD-L1 expression (CPS 10-20) will receive neoadjuvant chemotherapy combined with immunotherapy. This includes paclitaxel and cisplatin along with serplulimab for 2 cycles. |
| Low PD-L1 Expression Group (CPS < 10) | Experimental | Drug: Paclitaxel+Cisplatin(Concurrent Chemoradiotherapy), Radiation: RadiotherapyPatients with low PD-L1 expression (CPS < 10) will receive standard neoadjuvant chemoradiotherapy. This includes paclitaxel and cisplatin along with radiotherapy (40 Gy in 20 fractions over 4 weeks). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Diagnosis: Histologically confirmed esophageal squamous cell carcinoma (ESCC).
- Stage: Resectable locally advanced ESCC (clinical stage II-III according to the AJCC/UICC 8th edition).
- Age: 18-75 years old.
- Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- PD-L1 Expression: Available PD-L1 expression level (CPS).
Key exclusion criteria (8 listed)
- Distant Metastasis: Presence of distant metastasis.
- Other Malignancies: History of other malignancies within the past 5 years, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin carcinoma, or other localized non-invasive malignancy.
- Autoimmune Diseases: History of active autoimmune diseases requiring systemic treatment within the past 2 years.
- Infections: Active infection requiring systemic therapy.
- Uncontrolled Conditions: Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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 |
|---|---|---|
| SerplulimabSerplulimab (300 mg) administered intravenously on day 1 of each 21-day cycle for 2 cycles. | Drug | High PD-L1 Expression Group (CPS ≥ 20), Moderate PD-L1 Expression Group (CPS 10-20) |
| Paclitaxel+Cisplatin (Neoadjuvant Chemotherapy)Paclitaxel (175 mg/m²) and Cisplatin (75 mg/m²) administered intravenously on day 1 of each 21-day cycle for 2 cycles as part of neoadjuvant chemotherapy. | Drug | Moderate PD-L1 Expression Group (CPS 10-20) |
| Paclitaxel+Cisplatin(Concurrent Chemoradiotherapy)Paclitaxel (50 mg/m²) and Cisplatin (25 mg/m²) administered intravenously on days 1, 8, 15, and 22 of a 4-week cycle as part of concurrent chemoradiotherapy. | Drug | Low PD-L1 Expression Group (CPS < 10) |
| RadiotherapyRadiotherapy at a dose of 40 Gy, delivered in 20 fractions over 4 weeks. | Radiation | Low PD-L1 Expression Group (CPS < 10) |
Primary outcome
Pathological Complete Response (pCR) Rate
Time frame: after the pathological examination of surgical speciments within 14 days after the operation
The proportion of patients achieving a pathological complete response (pCR) after neoadjuvant treatment and surgical resection. pCR is defined as the absence of any residual invasive cancer in the resected esophagus and all sampled lymph nodes (ypT0N0) based on hematoxylin and eosin staining.
7 secondary outcomes
R0 Resection Rate
Time frame: after the pathological examination of surgical speciments ie within 14 days after the operation
Treatment-Related Toxicity
Time frame: From the start of treatment to 30 days post-surgery
3-Year Disease-Free Survival (DFS)
Time frame: 36 months after treatment completion
Tumor Mutational Burden (TMB)
Time frame: 36 months after treatment completion.
Microsatellite Instability (MSI)
Time frame: 36 months after treatment completion
Circulating Tumor DNA (ctDNA)
Time frame: 36 months after treatment completion
major pathological response
Time frame: Patients were evaluated 2 to 4 weeks postoperatively.
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 23 Oct 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Serplulimab, Paclitaxel+Cisplatin (Neoadjuvant Chemotherapy) and Paclitaxel+Cisplatin(Concurrent Chemoradiotherapy) in people with Esophageal Squamous Cell Carcinoma, run by Fujian Medical University Union 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 11 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: looking for participants now, as of the sponsor's last update on 23 Oct 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Zhao-han Lin (0086-0591-86218329, xhyyllwyh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (pCR) Rate (time frame: after the pathological examination of surgical speciments within 14 days after the operation). 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 23 Oct 2026.