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NCT06388135

PHASE4

Serplulimab Combined With Nab-paclitaxel and Cisplatin in Neoadjuvant Therapy for Resectable Esophageal Squamous Cell Carcinoma

Sponsor: Yang Jianjun, PhD

View on ClinicalTrials.gov

Summary

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).

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-05-01

Completion Date

2027-05

Last Updated

2024-04-29

Healthy Volunteers

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

DRUG

Serplulimab Combined With Nab-paclitaxel and 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.

DRUG

nab-paclitaxel，Cisplatin

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.

Clinical Research Directory

Serplulimab Combined With Nab-paclitaxel and Cisplatin in Neoadjuvant Therapy for Resectable Esophageal Squamous Cell Carcinoma

Summary

Key Details

Conditions

Interventions

Eligibility Criteria