A Randomized, Controlled, Phase II Study of Perioperative Camrelizumab Combined With Albumin Paclitaxel and Cisplatin in Patients With Resectable Esophageal Squamous Cell Carcinoma

Who is this study for? Patients with resectable esophageal squamous cell carcinoma
What treatments are being studied? Camrelizumab+Albumin Paclitaxel+Cisplatin
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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;

⁃ For premenopausal women (postmenopausal women must have been postmenopausal for at least 12 months to be considered infertile), the serum pregnancy test result is negative. Male subjects (including male subjects' female spouses of childbearing age) and female subjects of childbearing age must contraception from the first study drug administration to 6 months after the last study drug administration;

⁃ Obtain the informed consent signed by the subject or his legal representative;

⁃ Can cooperate to complete research procedures and follow-up inspections。

Locations
Other Locations
China
The First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Contact Information
Primary
Song Zhao
zhaosong@zzu.cn
13673665008
Backup
Yu Qi
qiyu@zzu.cn
13803892392
Time Frame
Start Date: 2022-01-15
Estimated Completion Date: 2027-01-15
Participants
Target number of participants: 130
Treatments
Experimental: 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)
Active_comparator: non-pCR patients adjuvant treatment
After 2 cycles of neoadjuvant therapy(Camrelizumab+Albumin Paclitaxel+Cisplatin), non-pCR patients adjuvant treatment(Camrelizumab maintenance treatment)
Experimental: pCR patients adjuvant treatment
After 2 cycles of neoadjuvant therapy(Camrelizumab+Albumin Paclitaxel+Cisplatin), pCR patients adjuvant treatment(Camrelizumab maintenance treatment)
Active_comparator: pCR patients adjuvant treatment(BSC)
After 2 cycles of neoadjuvant therapy(Camrelizumab+Albumin Paclitaxel+Cisplatin), pCR patients adjuvant treatment(Best Supportive Care)
Related Therapeutic Areas
Sponsors
Leads: The First Affiliated Hospital of Zhengzhou University

This content was sourced from clinicaltrials.gov

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