New Biomarker-Guided cocktail aims to wipe out esophageal cancer before surgery
NCT ID NCT06601309
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This phase 2 trial is testing whether a personalized treatment plan based on a biomarker (CPS score) can improve outcomes for people with a certain type of esophageal cancer. Participants will receive a combination of the immunotherapy drug serplulimab, chemotherapy, and possibly radiation before surgery. The main goal is to see how many patients have no cancer left in their removed tissue. The study is currently recruiting 90 adults aged 18-75 with resectable, locally advanced esophageal squamous cell carcinoma.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Serplulimab (immunotherapy) plus paclitaxel and cisplatin (chemotherapy), with or without radiotherapy
- What this could lead to
- If successful, this approach could increase the chance of eliminating all cancer before surgery, potentially improving long-term outcomes for patients with locally advanced esophageal cancer.
- What could go wrong
- This is an early phase 2 trial with only 90 participants, so results may not apply broadly. The combination of treatments may cause significant side effects, and the benefit over standard care is not yet proven.
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 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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 to 75 years
- 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. Diagnosis: Histologically confirmed esophageal squamous cell carcinoma (ESCC). 2. Stage: Resectable locally advanced ESCC (clinical stage II-III according to the AJCC/UICC 8th edition). 3. Age: 18-75 years old. 4. Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 5. PD-L1 Expression: Available PD-L1 expression level (CPS). 6. Surgical Eligibility: Assessed as eligible for surgical resection by a thoracic surgeon. 7. 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. 8. Informed Consent: Ability to understand and willingness to sign a written informed consent document. Exclusion Criteria: 1. Distant Metastasis: Presence of distant metastasis. 2. 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. 3. Autoimmune Diseases: History of active autoimmune diseases requiring systemic treatment within the past 2 years. 4. Infections: Active infection requiring systemic therapy. 5. 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. 6. Previous Treatment: Previous treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies. 7. Pregnancy and Lactation: Pregnant or breastfeeding women. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization. 8. Allergies: Known allergy or hypersensitivity to study drugs or any excipient of these medications.
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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 places running it
1 site. The list below names each one and where it is.
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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.
Contacts and locations
Locations
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Fujian Medical University Union Hospital
RECRUITINGFuzhou, Fujian, 350001, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Experimental drug put to the test against Hard-to-Treat GI cancers
- Can a drug combo shrink esophageal tumors before surgery?
- Two-Drug combo targets esophageal cancer that outsmarted immunotherapy
- Can a Triple-Drug combo shrink esophageal tumors before surgery?
- Can a Triple-Drug combo wipe out esophageal tumors before surgery?
- Dye-Guided surgery may spare healthy lymph nodes in esophageal cancer