- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06388135
Serplulimab Combined With Nab-paclitaxel and Cisplatin in Neoadjuvant Therapy for Resectable Esophageal Squamous Cell Carcinoma
Serplulimab Combined With Nab-paclitaxel and Cisplatin in Neoadjuvant Therapy for Resectable Esophageal Squamous Cell Carcinoma: a Study Protocol of Prospective Single-center, Open Label and Exploratory Cohort Study (SNC-01)
Abstract Objective: This study aims to investigate the potential clinical impact of neoadjuvant immunotherapy in resectable esophageal squamous cell carcinoma (ESCC).
The efficacy and safety of combining the programmed death 1 (PD-1) inhibitor serplulimab with nab-paclitaxel and cisplatin as neoadjuvant therapy in patients with resectable ESCC will be evaluated. Methods and analysis: A prospective, single-center, open-label cohort study will enroll 80 patients, with 40 patients allocated to the experimental group and 40 patients to the control group. Patients in the experimental arm will undergo 3 cycles of neoadjuvant therapy comprising serplulimab, cisplatin, and nab-paclitaxel, while those in the control arm will receive 3 cycles of neoadjuvant therapy with cisplatin and nab-paclitaxel. The primary efficacy endpoint will be the assessment of pathological complete response (pCR) following neoadjuvant therapy. Secondary efficacy endpoints will include major pathological response (MPR), disease-free survival, objective response rate (ORR), and monitoring of adverse events (AEs).
Ethics: Ethics approval has been obtained from the Ethics Committee at the First Affiliated Hospital (Xijing Hospital) of Air force Military Medical University (KY20242052-C-1).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Wang Juan, ph.D
- Phone Number: 29-84771531
- Email: wangjuan861016@126.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria:
- The age range of the enrolled patients was 18-70 years;
- ECOG score 0-1 ;
- Patients with ESCC diagnosed by pathology (histology or cytology);
- Resectable IB-III (cT1b~3N1-2M0 or cT3~4aN0~1M0) stage per the 8th edition of clinical TNM staging;
- Measurable lesions (per RECIST 1.1 criteria: major tumor diameter on CT scan ≥10mm, short lymph node diameter on CT scan ≥15mm);
- No prior radiotherapy, chemotherapy, surgery, or targeted therapy;
- Surgical tolerance and ability to consume liquid diet without esophageal complications;
- Normal major organ function criteria: (1) Blood tests: ANC ≥ 1.5 × 109/L, PLT ≥ 100 × 109/L, HB ≥ 90 g/L; (2) Biochemical tests: TBIL≤1.5×ULN, ALT/AST≤ 2.5×ULN, serum creatinine ≤1.5×ULN, ALB ≥ 30 g/L; (3) Coagulation function: INR≤1.5×ULN, APTT≤1.5×ULN;
- Normal or mildly to moderately abnormal lung function suitable for EC surgery: A) VC%>60%, B) FEV1>1.2L, FEV1%>40%, C) DLCO>40%;
- Voluntary participation with informed consent and good compliance.
The exclusion criteria were as follows:
- Any current or past presence of autoimmune diseases;
- Patients with immune deficiency disorders like HIV infection, active hepatitis B (HBV DNA ≥ 500 IU/ML), hepatitis C (HCV antibody positive, and HCV-RNA above the detection limit), or co-infection with hepatitis B and hepatitis C;
- Patients who have taken immunosuppressive drugs within 14 days before enrollment; patients who experienced a weight loss of ≥10% within 6 months prior to enrollment, or have a BMI below 18.5kg/m2, or have a PG-SGA score indicating grade C;
- Patients who had attenuated live vaccines within 4 weeks before enrollment;
- History of other cancers;
- Patients with myocardial infarction within six months before enrollment or diagnosed with New York Heart Association grade ≥ II heart failure;
- Patients who have experienced severe infections or undergone allogeneic organ transplantation or hematopoietic stem cell transplantation within the 4 weeks preceding enrollment;
- Patients with substance abuse, alcohol consumption, or psychotropic substance use.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Serplulimab,nab-paclitaxel,Cisplatin
Serplulimab (200 mg), cisplatin (60-75 mg/m2), and nab-paclitaxel (135 mg/m2) administered intravenously at the beginning of every 3-week cycle
|
Serplulimab (200 mg), cisplatin (60-75 mg/m2), and nab-paclitaxel (135 mg/m2) administered intravenously at the beginning of every 3-week cycle.
|
Sham Comparator: nab-paclitaxel,Cisplatin
Cisplatin (60-75 mg/m2) and nab-paclitaxel (135 mg/m2) given intravenously at the beginning of every 3-week cycle.
|
nab-paclitaxel,Cisplatin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pCR
Time Frame: after surgery,within 12 weeks
|
pathological Complete Response
|
after surgery,within 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MPR
Time Frame: after surgery,within 12 weeks
|
major pathologic response
|
after surgery,within 12 weeks
|
DFS
Time Frame: up to 24 months
|
Disease free survival
|
up to 24 months
|
ORR
Time Frame: up to 24 months
|
objective response rate
|
up to 24 months
|
AEs
Time Frame: up to 24 months
|
adverse events
|
up to 24 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Neoplasms, Squamous Cell
- Esophageal Neoplasms
- Carcinoma
- Carcinoma, Squamous Cell
- Esophageal Squamous Cell Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
- Cisplatin
- Albumin-Bound Paclitaxel
Other Study ID Numbers
- SNC-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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