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

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

NCT ID: NCT06388135

Condition: Esophageal Squamous Cell Carcinoma

Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin

Study type: Interventional

Study phase: Phase 4

Overall status: Not yet recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Intervention:

Intervention type: Drug
Intervention name: Serplulimab Combined With Nab-paclitaxel and Cisplatin
Description: Serplulimab (200 mg), cisplatin (60-75 mg/m2), and nab-paclitaxel (135 mg/m2) administered intravenously at the beginning of every 3-week cycle.
Arm group label: Serplulimab，nab-paclitaxel，Cisplatin

Intervention type: Drug
Intervention name: nab-paclitaxel，Cisplatin
Description: nab-paclitaxel，Cisplatin
Arm group label: nab-paclitaxel，Cisplatin

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).

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Start date: May 1, 2024

Completion date: May 2027

Lead sponsor:
Agency: Yang Jianjun, PhD
Agency class: Other

Source: Xijing Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06388135