Nimotuzumab,Camrelizumab, and Neoadjuvant Chemotherapy（nCT） in the Treatment of Esophageal Squamous Cell Carcinoma

Sponsor
Peking University
Study ID
NCT07312578
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

  • Esophageal Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Nimotuzumab — DRUG
    Nimotuzumab 400mg
  • camrelizumab — DRUG
    camrelizumab 200mg
  • Albumin paclitaxel — DRUG
    Albumin paclitaxel 125mg/m2
  • Cisplatin — DRUG
    Cisplatin 75mg/m2

Study Details

We plan to conduct a single-center,prospective, Open Label, Randomized Controlled, Phase II Clinical Study of the Combination of Nimotuzumab,Camrelizumab, and Neoadjuvant Chemotherapy in the Treatment of Locally Advanced Resectable Esophageal Squamous Cell Carcinoma

Key Dates

Start date
Nov 1, 2025
Status verified
Nov 2025
Primary completion
Nov 1, 2027
Completion
Nov 1, 2027

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nimotuzumab+Camrelizumab+Neoadjuvant chemotherapy（nCT）
    Experimental group: 1. Nimotuzumab: 400mg, Intravenous（iv）, day1（D1）, quaque week（QW）, 6 cycles; 2. Camrelizumab: 200mg, iv, D1, Q3W, 2 cycles; 3. Albumin paclitaxel: 125mg/m2, iv, D1, D8, Q3W, 2 cycles; 4. Cisplatin: 75mg/m2, iv, D1, Q3W, 2 cycles.
  • Active Comparator: Camrelizumab+Neoadjuvant chemotherapy（nCT）
    1. Camrelizumab: 200mg, iv, D1, Q3W, 2 cycles; 2. Albumin paclitaxel: 125mg/m2, iv, D1, D8, Q3W, 2 cycles; 3. Cisplatin: 75mg/m2, iv, D1, Q3W, 2 cycles.

Primary Outcome Measure

Pathological complete response (pCR) rate [ Time Frame: up to 2 years ]

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