Small-Cell Carcinoma of the EsophagealPhase 2NCT07155122
Efficacy and Safety of Serplulimab Combined With Etoposide and Cisplatin as Neoadjuvant Therapy in Limited-Stage Small-Cell Carcinoma of the Esophageal
A Phase 2 study testing Drug: Serplulimab, Drug: Etoposide and Drug: Chemotherapy in people with Small-Cell Carcinoma of the Esophageal, run by Fujian Cancer Hospital.
Trial summary
This study is a prospective, single-center, single-arm phase II clinical trial designed to evaluate the efficacy and safety of serplulimab in combination with etoposide and platinum-based chemotherapy as neoadjuvant treatment for patients with limited-stage small cell carcinoma of the esophagus (SCCE). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small-Cell Carcinoma of the Esophageal
- What is being tested?
- Drug: Serplulimab, Drug: Etoposide and Drug: Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Sep 2030
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged ≥18 years;
- Histologically or cytologically confirmed diagnosis of SCCE prior to initiation of any treatment;
- Clinical stage cT2-4aNxM0 or cT1N+M0, corresponding to limited-stage SCCE based on the American Joint Committee on Cancer (AJCC) staging systemand the Veterans Administration Lung Study Group (VALSG) classification for small cell lung cancer;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- For women of childbearing potential, a negative serum or urine pregnancy test (minimum sensitivity of 25 IU/L or equivalent) within 48 hours prior to the first administration of the study drug. Female patients must not be breastfeeding;
- All participants were required to undergo baseline laboratory evaluations within two weeks prior to treatment, and the results must meet the following criteria (based on CTCAE version 5.0):White blood cell count ≥ 3,000/μL; Absolute neutrophil count ≥ 1,500/μL; Platelet count ≥ 75 × 10³/μL; Hemoglobin ≥ 9.0 g/dL; Creatinine clearance > 30 mL/min (calculated by the Cockcroft-Gault formula); Aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN); Alanine aminotransferase (ALT) ≤ 3 × ULN; Total bilirubin ≤ 1.5 × ULN.
- Written informed consent must be obtained prior to the initiation of any study-related procedures. The informed consent form must be reviewed and approved by the institutional ethics committee. Participants must be willing and able to comply with the study protocol, including treatment, visit schedule, biospecimen collection, and other study-related requirements.
Who cannot join
- Patients with esophageal cancer of any histological type other than small cell carcinoma;
- Patients clinically staged as cT4bNanyM0, cTanyN3M0, or cTanyNanyM1;
- History of other malignancies, unless the patient has achieved complete remission for at least 3 years prior to enrollment and does not require or is not expected to require additional treatment during the study period;
- Known or suspected active autoimmune diseases. However, patients with type I diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, skin disorders not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger may be included;
- Systemic treatment with corticosteroids (>10 mg/day of prednisone or equivalent) or other immunosuppressive agents within 14 days prior to administration of study drugs. Inhaled, topical, or adrenal replacement corticosteroids at doses >10 mg/day of prednisone equivalent are permitted in the absence of active autoimmune disease;
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibodies, or any other agents targeting T-cell co-stimulatory or immune checkpoint pathways;
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- Any serious or uncontrolled medical conditions or active infections that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, or may interfere with the patient's ability to receive the planned treatment;
- Known history of HIV infection or acquired immunodeficiency syndrome (AIDS). (Note: HIV testing must be performed at study centers where required by local regulations);
- Clinically significant arrhythmias, myocardial ischemia, severe atrioventricular block, heart failure, or significant valvular heart disease; severe pulmonary dysfunction; hematologic, hepatic, or renal dysfunction precluding tolerance to chemoradiotherapy; severe bone marrow failure; or uncontrolled infections;
- Inability to comply with the study protocol and procedures;
- Known hypersensitivity to any component of the investigational agents used in this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of Serplulimab Combined With Etoposide and Cisplatin as Neoadjuvant Therapy in Limited-Stage Small-Cell Carcinoma of the Esophageal : A Single-Arm, Phase II Clinical Study
This study is a prospective, single-center, single-arm phase II clinical trial designed to evaluate the efficacy and safety of serplulimab in combination with etoposide and platinum-based chemotherapy as neoadjuvant treatment for patients with limited-stage small cell carcinoma of the esophagus (SCCE). The primary endpoint is the pathological complete response (pCR) rate. Secondary endpoints include major pathological response (MPR) rate, objective response rate (ORR), disease control rate (DCR), disease-free survival (DFS), overall survival (OS) and safety. A total of 15 patients are expected to be enrolled.
Read the detailed description
Small cell carcinoma of the esophagus (SCCE) is a rare but highly aggressive subtype of esophageal cancer, accounting for approximately 0.4% to 2.8% of all esophageal malignancies. It is characterized by high malignancy, a strong tendency for early metastasis, and poor prognosis. Currently, there is no standardized treatment regimen for SCCE. The efficacy of chemotherapy is limited, and resistance often develops rapidly. With the advancement of cancer immunotherapy, PD-1/PD-L1 inhibitors have demonstrated significant efficacy across various solid tumors. Given the biological and molecular similarities between SCCE and small cell lung cancer (SCLC), immune checkpoint inhibitors may offer a novel therapeutic avenue for patients with SCCE.This study is a prospective, single-center, single-arm phase II clinical trial designed to evaluate the efficacy and safety of serplulimab in combination with etoposide and platinum-based chemotherapy as neoadjuvant treatment for patients with limited-stage small cell carcinoma of the esophagus (SCCE). The preoperative neoadjuvant treatment drugs are f serplulimab + etoposide + platinum, with a cycle of 3 weeks. The combined treatment is given for 2 cycles. Radical resection of esophageal cancer is performed 4 to 6 weeks after the last dose. After surgery, the researcher decides whether to continue adjuvant treatment based on the pathological condition.
- Conditions
- Small-Cell Carcinoma of the Esophageal
- Being tested
- Drug: Serplulimab, Drug: Etoposide, Drug: Chemotherapy
- Keywords
- Small Cell Carcinoma of the Esophagus, Neoadjuvant Therapy, Serplulimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug: SerplulimabDrug
serplulimab Serplulimab , 300mg, D1, intravenous drip , Q3W.
Drug: EtoposideDrug
Etoposide, 60-100 mg/m², D1-3 or D1-5, intravenous drip, Q3W
Drug: ChemotherapyDrug
Cisplatin, 50-75 mg/m², D2, intravenous drip, Q3W. Or Carboplatin, AUC 5, D2, intravenous drip, Q3W.
| Study group | Role | What they receive |
|---|---|---|
| Serplulimab Combined With Etoposide and Cisplatin | Experimental | Not described Receives: Drug: Drug: Serplulimab; Drug: Drug: Etoposide; Drug: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathological complete response rate (pCR)
Measured: Each 2 cycles (each cycle is 21 days).
Secondary outcomes (6)
Major pathological response rate (MPR)
Measured: Each 2 cycles (each cycle is 21 days).
Objective response rate (ORR)
Measured: Each 2 cycles (each cycle is 21 days).
Disease control rate (DCR)
Measured: Each 2 cycles (each cycle is 21 days).
Disease-free survival (DFS)
Measured: 36-months
Overall survival (OS)
Measured: 36-months
Safety: The incidence and severity of adverse events (AE) and serious adverse events (SAE)
Measured: From the time the subject is enrolled until the 90th day after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small-Cell Carcinoma of the EsophagealStudies of the same condition, open and under way.
- More trials run by Fujian Cancer 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07155122
- Sponsor's protocol ID
- SFWM-01
- Status last verified
- Sep 2025
- First submitted
- 27 Aug 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Serplulimab Combined With Etoposide and Cisplatin as Neoadjuvant Therapy in Limited-Stage Small-Cell Carcinoma of the Esophageal : A Single-Arm, Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT07155122
- Acronym / sponsor ID
- SFWM-01
- Conditions
- Small-Cell Carcinoma of the Esophageal
- Keywords
- Small Cell Carcinoma of the Esophagus, Neoadjuvant Therapy, Serplulimab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 4 Sep 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 study is a prospective, single-center, single-arm phase II clinical trial designed to evaluate the efficacy and safety of serplulimab in combination with etoposide and platinum-based chemotherapy as neoadjuvant treatment for patients with limited-stage small cell carcinoma of the esophagus (SCCE). The primary endpoint is the pathological complete response (pCR) rate. Secondary endpoints include major pathological response (MPR) rate, objective response rate (ORR), disease control rate (DCR), disease-free survival (DFS), overall survival (OS) and safety. A total of 15 patients are expected to be enrolled.
Detailed description
Small cell carcinoma of the esophagus (SCCE) is a rare but highly aggressive subtype of esophageal cancer, accounting for approximately 0.4% to 2.8% of all esophageal malignancies. It is characterized by high malignancy, a strong tendency for early metastasis, and poor prognosis. Currently, there is no standardized treatment regimen for SCCE. The efficacy of chemotherapy is limited, and resistance often develops rapidly. With the advancement of cancer immunotherapy, PD-1/PD-L1 inhibitors have demonstrated significant efficacy across various solid tumors. Given the biological and molecular similarities between SCCE and small cell lung cancer (SCLC), immune checkpoint inhibitors may offer a novel therapeutic avenue for patients with SCCE.This study is a prospective, single-center, single-arm phase II clinical trial designed to evaluate the efficacy and safety of serplulimab in combination with etoposide and platinum-based chemotherapy as neoadjuvant treatment for patients with limited-stage small cell carcinoma of the esophagus (SCCE). The preoperative neoadjuvant treatment drugs are f serplulimab + etoposide + platinum, with a cycle of 3 weeks. The combined treatment is given for 2 cycles. Radical resection of esophageal cancer is performed 4 to 6 weeks after the last dose. After surgery, the researcher decides whether to continue adjuvant treatment based on the pathological condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Serplulimab Combined With Etoposide and Cisplatin | Experimental | Drug: Drug: Serplulimab, Drug: Drug: Etoposide, Drug: Drug: Chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female patients aged ≥18 years;
- Histologically or cytologically confirmed diagnosis of SCCE prior to initiation of any treatment;
- Clinical stage cT2-4aNxM0 or cT1N+M0, corresponding to limited-stage SCCE based on the American Joint Committee on Cancer (AJCC) staging systemand the Veterans Administration Lung Study Group (VALSG) classification for small cell lung cancer;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- For women of childbearing potential, a negative serum or urine pregnancy test (minimum sensitivity of 25 IU/L or equivalent) within 48 hours prior to the first administration of the study drug. Female patients must not be breastfeeding;
Key exclusion criteria (11 listed)
- Patients with esophageal cancer of any histological type other than small cell carcinoma;
- Patients clinically staged as cT4bNanyM0, cTanyN3M0, or cTanyNanyM1;
- History of other malignancies, unless the patient has achieved complete remission for at least 3 years prior to enrollment and does not require or is not expected to require additional treatment during the study period;
- Known or suspected active autoimmune diseases. However, patients with type I diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, skin disorders not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger may be included;
- Systemic treatment with corticosteroids (>10 mg/day of prednisone or equivalent) or other immunosuppressive agents within 14 days prior to administration of study drugs. Inhaled, topical, or adrenal replacement corticosteroids at doses >10 mg/day of prednisone equivalent are permitted in the absence of active autoimmune disease;
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 |
|---|---|---|
| Drug: Serplulimabserplulimab Serplulimab , 300mg, D1, intravenous drip , Q3W. | Drug | Serplulimab Combined With Etoposide and Cisplatin |
| Drug: EtoposideEtoposide, 60-100 mg/m², D1-3 or D1-5, intravenous drip, Q3W | Drug | Serplulimab Combined With Etoposide and Cisplatin |
| Drug: ChemotherapyCisplatin, 50-75 mg/m², D2, intravenous drip, Q3W. Or Carboplatin, AUC 5, D2, intravenous drip, Q3W. | Drug | Serplulimab Combined With Etoposide and Cisplatin |
Primary outcome
pathological complete response rate (pCR)
Time frame: Each 2 cycles (each cycle is 21 days).
6 secondary outcomes
Major pathological response rate (MPR)
Time frame: Each 2 cycles (each cycle is 21 days).
Objective response rate (ORR)
Time frame: Each 2 cycles (each cycle is 21 days).
Disease control rate (DCR)
Time frame: Each 2 cycles (each cycle is 21 days).
Disease-free survival (DFS)
Time frame: 36-months
Overall survival (OS)
Time frame: 36-months
Safety: The incidence and severity of adverse events (AE) and serious adverse events (SAE)
Time frame: From the time the subject is enrolled until the 90th day after the last dose
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 12 Sep 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Drug: Serplulimab, Drug: Etoposide and Drug: Chemotherapy in people with Small-Cell Carcinoma of the Esophageal, run by Fujian Cancer Hospital.
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 7 inclusion and 11 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: opening soon, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Yijin Lin (+86 13067275771, a7570794@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 rate (pCR) (time frame: Each 2 cycles (each cycle is 21 days).). 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 12 Sep 2025.