Neoadjuvant Chemotherapy With Camrelizumab in Locally Advanced Esophageal Squamous Cell

Sponsor
Fudan University
Study ID
NCT04520035
Phase
PHASE2
Status
Unknown

Conditions

  • PFS

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • camrelizumab — DRUG
    Carilizumab 200 mg, every 3 weeks, 2 cycles.Paclitaxel 175 mg / m2, D1, every 3 weeks, 2 cycles
  • Paclitaxel — DRUG
    Cisplatin 75mg / m2 D1, conventional hydration for 3 days, every 3 weeks, 2 cycles
  • Neoadjuvant Chemotherapy — DRUG
    Neoadjuvant Chemotherapy

Study Details

A prospective, single arm, single center, phase II clinical trial of neoadjuvant chemotherapy with camrelizumab in locally advanced esophageal squamous cell,to evaluate the progression free survival

Key Dates

Start date
Aug 1, 2020
Status verified
Aug 2020
Primary completion
Dec 31, 2021
Completion
Dec 31, 2021

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: neoadjuvant chemotherapy with camrelizumab
    paclitaxel and cisplatin Carilizumab 200 mg, every 3 weeks, 2 cycles. Paclitaxel 175 mg / m2, D1, every 3 weeks, 2 cycles Cisplatin 75mg / m2 D1, conventional hydration for 3 days, every 3 weeks, 2 cycles

Primary Outcome Measure

Pathological complete response rate (pCR) [ Time Frame: from the first cycle of treatment (day one) to two month after the last cycle (each cycle is 21 days) ]

Central Contacts