The Phase II Trial of SHR-1210 Combined With Preoperative Chemotherapy or Apatinib for Locally Advanced ESCC

Sponsor
The First Affiliated Hospital of Zhengzhou University
Study ID
NCT03917966
Phase
PHASE2
Status
Unknown

Conditions

  • Locally Advanced Esophageal Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • SHR-1210+docetaxel+nedaplatin — DRUG
    neoadjuvant chemotherapy:SHR-1210, 200mg,q2w, a total of 3 times; docetaxel 75mg/m2 ivgtt d1, nedaplatin 75mg/m2 ivgtt d1, q3w, for 2 cycles.The patient was evaluated after 2 cycles of neoadjuvant chemotherapy. The surgery was performed 3-4 weeks after the completion of neoadjuvant chemotherapy.
  • SHR-1210+Apatinib — DRUG
    SHR-1210, 200 mg, q2w; Apatinib, 250mg, qd; 4 weeks is a cycle, a total of 2 cycles

Study Details

The purpose of this study is to observe and evaluate the efficacy and safety of SHR-1210 combined with preoperative chemotherapy or Apatinib for locally advanced esophageal squamous cell carcinoma

Key Dates

Start date
Apr 7, 2020
Status verified
Aug 2021
Primary completion
Oct 7, 2023
Completion
Oct 7, 2024

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SHR-1210+Docetaxel+nedaplatin
    SHR-1210+Docetaxel+nedaplatin
  • Experimental: SHR-1210+Apatinib
    SHR-1210+Apatinib

Primary Outcome Measure

Major pathological response（MPR） [ Time Frame: At time of surgery ]

Central Contacts