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New treatment option for Esophageal Squamous Cell Carcinoma
Official title Biomarker Based Neoadjuvant Strategies for Locally Advanced Resectable ESCC
ClinicalTrials.gov ID: NCT06601309
What this study is testing
What is Serplulimab?
Serplulimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for esophageal squamous cell carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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).
You likely can't join if
- 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...
- 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...
- Previous Treatment: Previous treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies.
See the full eligibility criteria
- 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.
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, Fujian, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuzhou, Fujian, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.