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

Esophageal Squamous Cell Carcinoma Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06388135
• Other study ID #: SNC-01
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 1, 2024
• Est. completion date: May 2027

Study information

• Verified date: April 2024
• Source: Xijing Hospital
• Contact: Wang Juan, ph.D
• Phone: 29-84771531
• Email: wangjuan861016[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: May 2027
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma

Intervention

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.
• nab-paclitaxel,Cisplatin
nab-paclitaxel,Cisplatin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yang Jianjun, PhD

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pCR	pathological Complete Response	after surgery,within 12 weeks
Secondary	MPR	major pathologic response	after surgery,within 12 weeks
Secondary	DFS	Disease free survival	up to 24 months
Secondary	ORR	objective response rate	up to 24 months
Secondary	AEs	adverse events	up to 24 months