Efficacy of Neoadjuvant PD-1 Blockade Plus Chemotherapy for Esophageal Squamous Cell Carcinoma

Sponsor
Guangzhou Institute of Respiratory Disease
Study ID
NCT04225364
Phase
PHASE2
Status
Completed

Conditions

  • Esophageal Squamous Cell Carcinoma
  • Immunotherapy

Eligibility Criteria

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

Interventions

  • camrelizumab — DRUG
    Participants will receive camrelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks for 6 weeks. Discontinuation will be considered due to toxicity, withdrawal of consent, or end of study. Every 3-week treatment period was considered to be a cycle.
  • Paclitaxel for injection (albumin-bound) — DRUG
    Paclitaxel for injection (albumin-bound): 260mg/m2(in total), ivgtt d1, d8, q3w，for 2 cycle
  • Cisplatin — DRUG
    75mg/m2(in total), ivgtt d1-d3, q3w, for 2 cycles

Study Details

This study aims to evaluate the efficacy of Camrelizumab plus concurrent chemotherapy as neoadjuvant approach for patients with opearble esophageal squamous cell carcinoma. In addition, potential clinical utility of ctDNA in monitoring tumor burden and dynamics of tumor clonality during neoadjuvant immunotherapy will be assessed as well. At the same time, CD8 and PD-L1 will also be used as monitoring indicators.

Key Dates

Start date
Jan 17, 2020
Status verified
Jan 2021
Primary completion
Jan 15, 2021
Completion
Jan 31, 2021

Study Design

Enrollment
56 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: camrelizumab plus concurrent chemotherapy
    Neoadjuvant immunotherapy, PD-1, plus concurrent chemotherapy（albumin-bound paclitaxel + Cisplatin） will be applied to patients with operable esophageal squamous cell carcinoma before surgery.

Primary Outcome Measure

Pathologic complete remission (PCR) [ Time Frame: 4 weeks after surgery ]

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