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Combination of Toripalimab and Neoadjuvant Chemoradiotherapy in Esophageal Cancer

NCT04006041 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2019-12-26

No results posted yet for this study

Summary

Neoadjuvant chemoradiotherapy (CRT) followed by surgery has become the standard treatment option for locally advanced esophageal cancer (EC). However, only 20% to 40% of EC patients can achieve pathologic complete response (pCR) after neoadjuvant CRT with favorable prognosis. Immunotherapy targeting the PD-1/PD-L1 checkpoints has demonstrated promising activity in advanced EC. The aim of this study was to evaluate the efficacy and safety of the combination of toripalimab (an anti-PD-1 antibody) combined with neoadjuvant CRT in locally advanced esophageal squamous cell carcinoma (ESCC).

Conditions

  • Esophageal Squamous Cell Carcinoma by AJCC V8 Stage
  • Resectable Esophageal Cancer

Interventions

DRUG

Toripalimab

Patients received toripalimab 240 mg IVDRIP on days 1 and 22 during neoadjuvant radiotherapy.

DRUG

Paclitaxel/cisplatin

Patients received 4 cycles of paclitaxel/cisplatin (paclitaxel 50mg/m2 and cisplatin 25 mg/m2) on days 1, 8, 15, 22 during neoadjuvant radiotherapy.

RADIATION

Intensity-modulated radiotherapy

All patients received external-beam radiation using intensity-modulated radiotherapy. The prescribed dose is 44 Gy in 20 fractions over 4 weeks.

PROCEDURE

Esophagectomy

A transthoracic (Ivor-Lewis) esophagectomy is performed 6-8 weeks after CRT completion.

Sponsors & Collaborators

  • Jianhua Fu

    lead OTHER

Principal Investigators

  • Jianhua Fu, MD · Sun Yat-sen University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2019-06-25
Primary Completion
2020-06-30
Completion
2020-12-31

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 NCT04006041 on ClinicalTrials.gov