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Sintilimab and Chemotherapy Sequential Radiotherapy in Advanced Esophageal Cancer

NCT06138028 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-07-24

No results posted yet for this study

Summary

This is an investigator-initiated, single-arm, exploratory clinical study.The study population consisted of treatment naive advanced esophageal squamous cell carcinoma patients. The purpose of this study was to evaluate the efficacy and safety of immunotherapy combined with chemotherapy and residual lesions irradiation of esophageal squamous cell carcinoma.

Conditions

  • Metastatic Esophageal Squamous Cell Carcinoma

Interventions

DRUG

TP regimen (cis-platinum ; Tocetaxel ) combined with PD-1 inhibitors（Sintilimab）

TP regimen (cis-platinum ; Tocetaxel ) combined with PD-1 inhibitors（Sintilimab）for 4 cycles, then irradiation of the residual lesions for 50Gy/2Gy/25f. After complete irradiation, sintilimab is administered every 21 days a cycle for additional 13 cycles.

Sponsors & Collaborators

  • Qingdao Central Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2023-09-20
Primary Completion
2025-10-31
Completion
2026-10-31

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 NCT06138028 on ClinicalTrials.gov