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Local Therapy for Oligorecurrent and Oligometastatic Esophageal Squamous Cell Carcinoma

NCT03904927 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2024-10-23

No results posted yet for this study

Summary

The aim of the study is to determine if intervening with combined local therapy and chemotherapy prior to chemotherapy alone in patients with oligorecurrent and oligometastatic esophageal squamous cell carcinoma led to significant improvements in progression-free survival (PFS).

Conditions

  • Oligorecurrent and Oligometastatic Esophageal Squamous Cell Carcinoma

Interventions

OTHER

Radiation, Surgery or Radiofrequency ablation

Patients with no more than 4 metastases located in less than 3 organs/ lymphatic drainage regions treated with combined systemic therapy and radiation, surgery or radiofrequency.

DRUG

Systemic therapy

1. First-line chemotherapy (previously without chemotherapy), paclitaxel 175mg/m2, d1+cisplatin 25mg/m2, d1-3, repeated every 28 days, intravenous infusion, a total of 4 cycles. 2. If patients have a history of chemotherapy, use a regimen of docetaxel 75mg/m2, d1, intravenous infusion, repeated every 21 days for a total of 4 cycles. If previously use docetaxel but not irinotecan, then use a regimen of irinotecan 180mg/m2, d1, d15, repeated every 28 days for a total of 4 cycles. If both docetaxel and irinotecan have been used, the investigator could decide the chemotherapy regimen. 3. Anti-PD1 antibodies plus chemotherapy could be used as first-line systemic therapy and Anti-PD1 antibodies could be used as second-line therapy.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-01
Primary Completion
2022-01-01
Completion
2024-09-15

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 NCT03904927 on ClinicalTrials.gov