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

NCT06388135 | Not Yet Recruiting Phase 4

• 1 other identifier: SNC-01
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• pCR

  pathological Complete Response

  after surgery,within 12 weeks

Secondary Outcomes (4)

• MPR

  after surgery,within 12 weeks

• DFS

  up to 24 months

• ORR

  up to 24 months

• AEs

  up to 24 months

Study Arms (2)

Serplulimab，nab-paclitaxel，Cisplatin

EXPERIMENTAL

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: Serplulimab Combined With Nab-paclitaxel and Cisplatin

nab-paclitaxel，Cisplatin

SHAM COMPARATOR

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

Drug: nab-paclitaxel，Cisplatin

Interventions

Serplulimab Combined With Nab-paclitaxel and Cisplatin 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.

Serplulimab，nab-paclitaxel，Cisplatin

nab-paclitaxel，Cisplatin DRUG

nab-paclitaxel，Cisplatin

nab-paclitaxel，Cisplatin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yang Jianjun, PhD: lead

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

130-nm albumin-bound paclitaxel; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Wang Juan, ph.D

CONTACT

29-84771531; wangjuan861016@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor from Xijing Hospital

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 29, 2024
• Study Start: May 1, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 29, 2024

Record last verified: 2024-04