Promising combo tackles rare esophageal cancer before surgery
NCT ID NCT07155122
First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether giving the immunotherapy drug serplulimab along with standard chemotherapy before surgery can help patients with a rare, limited-stage small cell cancer of the esophagus. The study will enroll 15 people and measure how many have no cancer cells left after treatment. The goal is to see if this approach is safe and effective enough to pursue in larger studies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Serplulimab (an immunotherapy drug) combined with etoposide and cisplatin (chemotherapy)
- What this could lead to
- If successful, this could lead to a new treatment option before surgery for a rare and aggressive esophageal cancer, potentially improving outcomes.
- What could go wrong
- This is a very small, early-phase trial with only 15 participants, so results may not apply broadly. The combination may cause significant side effects from both immunotherapy and chemotherapy.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2025
An estimate. Start dates often move.
- Expected to finish
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Sep 2030
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female patients aged ≥18 years; 2. Histologically or cytologically confirmed diagnosis of SCCE prior to initiation of any treatment; 3. 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; 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 5. 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; 6. 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. 7. 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. Exclusion Criteria: 1. Patients with esophageal cancer of any histological type other than small cell carcinoma; 2. Patients clinically staged as cT4bNanyM0, cTanyN3M0, or cTanyNanyM1; 3. 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; 4. 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; 5. 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; 6. 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; 7. 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; 8. Known history of HIV infection or acquired immunodeficiency syndrome (AIDS). (Note: HIV testing must be performed at study centers where required by local regulations); 9. 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; 10. Inability to comply with the study protocol and procedures; 11. Known hypersensitivity to any component of the investigational agents used in this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.