serplulimab combined with nab-paclitaxel and cisplatin in neoadjuvant therapy for resectable esophageal squamous cell carcinoma

Conditions: Esophageal Squamous Cell Carcinoma

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).


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.