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The Neoadjuvant Treatment of Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

NCT04937673 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-06-24

No results posted yet for this study

Summary

This is a randomized, open, two arm phase II clinical study. 40 patients are included in the exploratory study. The dominant population with higher biomarker positive / IO score was identified to provide the basis for the later phase III study. The subjects were randomly divided into the group of camrelizumab combined with paclitaxel and cisplatin or the group of camrelizumab combined with albumin bound paclitaxel and cisplatin according to the ratio of 1:1. The treatment cycle was every 3 weeks. The curative effect was evaluated when the treatment cycle was 2, and the resection of esophageal cancer was considered after 3 cycles. Postoperative adjuvant therapy was based on the patient's condition and surgical results; For patients with R0 resection, postoperative adjuvant treatment is not recommended. For patients with R1 / R2 resection, multi-disciplinary joint discussion and consultation are recommended to propose individualized comprehensive treatment.

Conditions

  • Thoracic Esophageal Squamous Cell Carcinoma

Interventions

DRUG

Camrelizumab+Albumin bound paclitaxel+Cisplatin

Camrelizumab: intravenous drip, fixed dose 200 mg, D1, repeated once every 3 weeks. Albumin bound paclitaxel: 130 mg / m2, intravenous drip for 30 minutes, D1, D8, repeated every 3 weeks. Cisplatin: 75 mg / m2, intravenous drip for 120 minutes, D1, repeated every 3 weeks.

DRUG

Camrelizumab+ Paclitaxel+ Cisplatin

Camrelizumab: intravenous drip, fixed dose 200 mg, D1, repeated once every 3 weeks. Paclitaxel: 80 mg / m2, intravenous drip for 180 minutes, D1, D8, repeated every 3 weeks. Cisplatin: 75 mg / m2, intravenous drip for 120 minutes, D1, repeated every 3 weeks.

Sponsors & Collaborators

  • Peking University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2022-09-01
Completion
2022-12-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04937673 on ClinicalTrials.gov