Efficacy of Neoadjuvant PD-1 Blockade Plus Chemotherapy for Esophageal Squamous Cell Carcinoma
Condition: Esophageal Squamous Cell Carcinoma; Immunotherapy
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims to evaluate the efficacy of Camrelizumab plus concurrent chemotherapy as
      neoadjuvant approach for patients with opearble esophageal squamous cell carcinoma. In
      addition, potential clinical utility of ctDNA in monitoring tumor burden and dynamics of
      tumor clonality during neoadjuvant immunotherapy will be assessed as well. At the same time,
      CD8 and PD-L1 will also be used as monitoring indicators.
    

Detailed description: 
      Immunotherapy improves clinical outcome of patients with advanced stage or metastatic
      esophageal squamous cell carcinoma (ESCC). In addition, superior effect of immunotherapy for
      esophageal squamous cell carcinoma was also reported recently. While, clinical application of
      ctDNA, PD-L1 and CD8 T cell monitoring in neoadjuvant immunotherapy for patients with
      esophageal squamous cell carcinoma is largely unknown. This trial will evaluate firstly the
      efficacy and the safety of Camrelizumab plus chemotherapy （albumin-bound paclitaxel plus
      cisplatin）as neoadjuvant approach. The evaluation indicators include pathological complete
      response rate (pCR) and objective imaging response rate after neoadjuvant therapy (ORR). ),
      2-year progression-free survival (2y-PFS), postoperative progression-free survival (PFS), and
      overall survival (OS) after treatment. Objective response rate (ORR) based upon
      immune-Response Evaluation Criteria in Solid Tumors Version (RECIST v1.1). Major pathological
      response assessed by post-operational pathological review ctDNA efficacy will also be
      evaluated along with clinical management. Monitoring tumor burden, clonality as well as tumor
      heterogeneity evaluation will be correlated to radiological assessment and pathological
      findings.
    

Intervention name(s): camrelizumab; Paclitaxel for injection (albumin-bound); Cisplatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive camrelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks for 6 weeks. Discontinuation will be considered due to toxicity, withdrawal of consent, or end of study. Every 3-week treatment period was considered to be a cycle.; Paclitaxel for injection (albumin-bound): 260mg/m2(in total), ivgtt d1, d8, q3w，for 2 cycle; 75mg/m2(in total), ivgtt d1-d3, q3w, for 2 cycles
Other intervention name(s): SHR-1210; paclitaxel; CDDP
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel
Intervention model: Single Group Assignment
Intervention model description: Patients with II-IVA stage with pathologically diagnosed squamous cell lung carcinoma will be enrolled in this study. Camrelizumab plus chemotherapy will be administrated intravenously per 3 weeks at the dosage of 200mg. Contrast-CT evaluation and peripheral blood collected will be performed at pre-neoadjuvant therapy and pre-operation. 6 weeks after neoadjuvant therapy, participants who meet the indication will be assigned to operation. Another peripheral blood sample will be harvested 3-4 weeks after operation.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: neoadjuvant immunotherapy; Stage II-IVA; esophageal squamous cell carcinoma; ctDNA; neoadjuvant chemotherapy