A Study of Sintilimab Combined With Chemotherapy for Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma

June 17, 2024 updated by: Fujian Cancer Hospital
This study is aimed to evaluate the efficacy and safety of sintilimab combined with chemotherapy (docetaxel+cisplatin+5-fluorouracil, DCF) in neoadjuvant treatment of locally advanced esophageal squamous cell carcinoma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study was designed as a single arm, phase II trial. Subjects will receive 3 cycles of Sintilimab combined with DCF as neoadjuvant therapy. The primary endpoint is pathologic complete response(pCR).

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Recruiting
        • Fujian Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ≥18 years old and ≤75 years old
  • Esophageal squamous cell carcinoma diagnosed biopsy histopathology
  • The primary tumor is located in the middle of the esophagus and T1b-3N1-3M0 /M1 or T3N0M0 diagnosed by CT/MRI/EUS (AJCC 8th)
  • At least one measurable lesion
  • Eastern cooperative oncology group (ECOG) performance status of 0 to 1
  • With adequate organs function

Exclusion Criteria:

  • Patients with active malignancy within 5 years other than the tumor studied in this study or a localized tumor that has been cured such as resected basal or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or breast cancer
  • Patients who have a higher risk of bleeding or perforation due to the tumor's obvious invasion of the adjacent organs (aorta or trachea) of the esophageal lesion, or patients who have formed a fistula
  • Patients who have received any anti-tumor therapy for the research disease in the past, including radiotherapy, chemotherapy, immunotherapy (including but not limited to interleukin, interferon, thymus hormone) and traditional Chinese medicine therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathological complete response
Time Frame: 4 weeks after surgery
Total tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell
4 weeks after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major pathological response
Time Frame: 4 weeks after surgery
Total/moderate tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell
4 weeks after surgery
Disease-free survival period
Time Frame: 3-year
After surgery, there is no time for the disease to recur.
3-year
Incidence rate of adverse events
Time Frame: 3-year
The ratio of the number of cases with adverse events to the total number of cases available for evaluation.
3-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2024

Primary Completion (Estimated)

March 19, 2025

Study Completion (Estimated)

March 19, 2028

Study Registration Dates

First Submitted

March 13, 2024

First Submitted That Met QC Criteria

June 17, 2024

First Posted (Actual)

June 18, 2024

Study Record Updates

Last Update Posted (Actual)

June 18, 2024

Last Update Submitted That Met QC Criteria

June 17, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FujianCH1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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