A Randomized, Controlled, Phase II Study of Perioperative Camrelizumab Combined With Albumin Paclitaxel and Cisplatin in Patients With Resectable Esophageal Squamous Cell Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- A：non-pCR patients
- Conditions
- Esophageal Cancer
- Sponsor
- The First Affiliated Hospital of Zhengzhou University
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- 3 years disease free survival, DFS
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of this study is to observe and evaluate the efficacy and safety of camrelizumab combined with albumin paclitaxel and cisplatin as perioperative treatment of advanced esophageal squamous cell.
Detailed Description
The incidence of esophageal cancer is ranked seventh in the world, and the mortality rate ranks sixth in the world. Surgical treatment of early esophageal cancer has a good prognosis, and advanced esophageal cancer often requires a combination of surgery, chemotherapy, radiotherapy and immunotherapy, but the prognosis is still poor. The investigators designed a randomized, controlled, phase II study of perioperative camrelizumab combined with albumin paclitaxel and cisplatin in patients with resectable esophageal squamous cell carcinoma. The purpose of this study is to observe and evaluate the efficacy and safety of camrelizumab combined with albumin paclitaxel and cisplatin as perioperative treatment of advanced esophageal squamous cell.
Investigators
Song Zhao
Principal Investigator
The First Affiliated Hospital of Zhengzhou University
Eligibility Criteria
Inclusion Criteria
- •Aged 18-80 years, males or females；
- •Histologically or cytologically confirmed as ESCC；
- •Esophageal squamous cell carcinoma without anti-tumor treatment, and the clinical stage is T1b-2N+M0 or T3-4aN+/-M0 (AJCC/UICC TNM staging system 8th edition);
- •It can provide tumor tissue for the detection of PD-L1 expression level;
- •Follow-up surgery plan: radical esophageal squamous cell carcinoma surgery with esophagogastric reconstruction combined with at least complete 2 field lymph node dissection;
- •ECOG: 0\~1;
- •Expected survival time ≥ 12 weeks;
- •Body mass index (BMI) ≥ 18.5kg/m2 or pg-sga score A / B;
- •1）White blood cell count (WBC) ≥3.0 × 109/L, absolute neutrophil count (ANC) ≥1.5 × 109/L, platelet (PLT) count ≥100×109/L, hemoglobin (HGB) ≥90 g/L, No blood transfusion or other hematopoietic factor treatment for the previous 14 days； 2）Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) ≤2.5×upper limit of normal (ULN); serum total bilirubin (TBIL) ≤1.5×ULN ; Albumin (ALB) ≥30g/L; 3）Serum creatinine (CRE)≤1.0×ULN, creatinine clearance (Ccr)≥60 mL/min (Cockcroft-Gault formula); 4）International normalized ratio (INR) ≤ 1.5, prothrombin time (PT) ≤ 1.5 × ULN;
- •Important organ functions: a) Heart function: normal or grade I; b) Lung function: FEV1\>1.2L, FEV1% \>40%; c) Liver function: Child-Pugh grade 5-6 points;
Exclusion Criteria
- •Cervical esophageal squamous cell carcinoma;
- •Combined with cervical, supraclavicular, abdominal, retroperitoneal and pelvic lymph node metastasis (except pericardial lymph node metastasis and left gastric lymph node metastasis);
- •Previously received anti-tumor therapy for the primary disease (including surgery, chemotherapy, targeted therapy, immunotherapy, anti-angiogenesis therapy, radiotherapy, radiofrequency ablation, etc.) and other research treatments, except for Chinese patent medicines or Chinese herbal medicines stopped for more than 7 days ；
- •Previously received anti-tumor therapy for the primary disease (including surgery, chemotherapy, targeted therapy, immunotherapy, anti-angiogenesis therapy, radiotherapy, radiofrequency ablation, etc.) and other research treatments, except for Chinese patent medicines or Chinese herbal medicines stopped for more than 7 days ；
- •Previously active, potentially relapsed or undiagnosed autoimmune diseases, skin diseases (vitiligo, psoriasis, alopecia) without systemic treatment, well controlled type I diabetes, hypothyroidism (only thyroid hormone replacement therapy), and other diseases that were not expected to relapse under external stimulation were included.
- •History of allogeneic stem cell transplantation or organ transplantation;
- •Complicated with interstitial pneumonia or interstitial lung disease, non infectious pneumonia;
- •History of gastrointestinal perforation and/or fistula, abdominal abscess, visceral fistula, intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), inflammatory bowel disease or extensive within 6 months before the first study drug administration bowel resection (including partial colectomy or extensive small bowel resection with chronic diarrhea), Crohn's disease, ulcerative colitis or chronic diarrhea;
- •Major operations (except puncture and biopsy) or major trauma were performed ≤ 28 days before the administration of the first study drug;
- •Have vaccinated or plan to vaccinate live vaccine within 28 days before the first study drug administration;
Arms & Interventions
After 2 cycles of neoadjuvant therapy,non-pCR patients adjuvant treatment
After 2 cycles of neoadjuvant therapy（Camrelizumab+Albumin Paclitaxel+Cisplatin）, non-pCR patients adjuvant treatment（2-4 cycles Camrelizumab+Albumin Paclitaxel +Cisplatin and Camrelizumab maintenance treatment）
Intervention: A：non-pCR patients
non-pCR patients adjuvant treatment
After 2 cycles of neoadjuvant therapy（Camrelizumab+Albumin Paclitaxel+Cisplatin）, non-pCR patients adjuvant treatment（Camrelizumab maintenance treatment）
Intervention: B：non-pCR patients
pCR patients adjuvant treatment
After 2 cycles of neoadjuvant therapy（Camrelizumab+Albumin Paclitaxel+Cisplatin）, pCR patients adjuvant treatment（Camrelizumab maintenance treatment）
Intervention: A：pCR patients
pCR patients adjuvant treatment(BSC)
After 2 cycles of neoadjuvant therapy（Camrelizumab+Albumin Paclitaxel+Cisplatin）, pCR patients adjuvant treatment（Best Supportive Care）
Intervention: B：pCR patients
Outcomes
Primary Outcomes
3 years disease free survival, DFS
Time Frame: up to 3 year
Time after R0 resection to disease recurrence or death
Pathologic complete response，pCR
Time Frame: At time of surgery
defined as the absence of any viable tumor at the time of surgical resection, as assessed by central and local pathology laboratory
Secondary Outcomes
- Objective Response Rate (ORR)(up to 2 year)
- Disease-Free Survival (DFS)(up to 5 year)
- Overall Survival (OS)(up to 5 year)
- Major pathological response（MPR）(At time of surgery)
- European Organisation for Research and Treatment of Cancer （EORTC） Multi-trait scaling analyses and face validity refined the module to four scales and six single items (QLQ-OES18).(up to 5 year)