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

NCT ID: NCT06388135

Last Updated: 2024-04-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2027-05-31

Brief 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).

Conditions

Esophageal Squamous Cell Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Serplulimab Combined With Nab-paclitaxel and Cisplatin

Intervention Type: DRUG

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

Cisplatin (60-75 mg/m2) and nab-paclitaxel (135 mg/m2) given intravenously at the beginning of every 3-week cycle.

Group Type: SHAM_COMPARATOR

nab-paclitaxel，Cisplatin

Intervention Type: DRUG

nab-paclitaxel，Cisplatin

Interventions

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.

Intervention Type: DRUG

nab-paclitaxel，Cisplatin

nab-paclitaxel，Cisplatin

Intervention Type: DRUG

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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yang Jianjun, PhD

OTHER

Sponsor Role: lead

Responsible Party

Yang Jianjun, PhD

Professor from Xijing Hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Wang Juan, ph.D

Role: CONTACT

wangjuan861016@126.com

29-84771531

Other Identifiers

SNC-01

Identifier Type: -

Identifier Source: org_study_id