Fact CheckerSign in

NCT06388135Not yet recruitingPhase 4

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

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)

Source: ClinicalTrials.gov · Last updated 29 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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).

Status (registry)
Not yet recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
80 (estimated)
First submitted
18 Apr 2024
Start date
1 May 2024
Primary completion date
May 2026
Lead sponsor
Yang Jianjun, PhD
NCT number
NCT06388135

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 80
  • From 1 May 2024 to the primary completion date, May 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.