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Short Course Neoadjuvant Chemo-radiotherapy Plus Toripalimab for Locally Advanced Resectble Squamous Cell Carcinoma of Esophagus

NCT05424432 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2022-06-27

No results posted yet for this study

Summary

Adding PD-1 inhibitors to neoadjuvant chemoradiotherapy has shown promising results in locally advanced resectable esophageal squamous cell carcinoma (ESCC). However, there is a need to explore safer and more effective treatment doses and schedules. This is an open labeled, prospective, single-arm phase II trial to evaluate the safety and efficacy of the short course neoadjuvant chemo-radiotherapy plus Toripalimab for locally advanced resectble ESCC.

Conditions

  • Locally Advanced Esophageal Carcinoma

Interventions

DRUG

Neoadjuvant Chemotherapy

Paclitaxel (135 mg /m2) and carboplatin (AUC=5) every 3 weeks for two cycles (D1,D22)

DRUG

Neoadjuvant Toripalimab

Toripalimab 240mg every 3 weeks for two cycles (D2,D23)

RADIATION

Short Course Neoadjuvant Radiotherapy

30 Gy in 12 fractions, 1 fraction per day, 5 days per week, D3-D18

Sponsors & Collaborators

  • Jiangsu Cancer Institute & Hospital

    lead OTHER

Principal Investigators

  • Xiangzhi Zhu, M.D. · Jiangsu Cancer Institute & Hospital

  • Ming Jiang, M.D. · Jiangsu Cancer Institute & Hospital

  • Feng Jiang, M.D. · Jiangsu Cancer Institute & Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2022-04-29
Primary Completion
2023-12-31
Completion
2024-12-31

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 NCT05424432 on ClinicalTrials.gov