Postoperative Immune Maintenance Therapy for Esophageal Squamous Cell Carcinoma After Radical Resection

November 30, 2023 updated by: Fujian Medical University Union Hospital

Postoperative Adjuvant Immune Maintenance Therapy for High Recurrence Risk Esophageal Squamous Cell Carcinoma After Radical Resection: a Multicenter Randomized Controlled Clinical Trial

Esophageal cancer (EC) is one of the most common malignant tumors of the digestive tract in human beings. Most cases of EC are initially diagnosed in an advanced stage of the disease. Considering the lack of effective adjuvant therapies after surgery for locally advanced esophageal squamous carcinoma. And with the encouraging preliminary results of PD-1 inhibitors in advanced esophageal squamous cell carcinoma (ESCC), postoperative adjuvant immunotherapy for esophageal squamous carcinoma seems to be feasible. The main objective of this study was the efficacy of postoperative adjuvant therapy with sintilimab in patients with ESCC radically resected after neoadjuvant chemoimmunotherapy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

sophageal cancer (EC) is one of the most common malignant tumors of the digestive tract in human beings. Most cases of EC are initially diagnosed in an advanced stage of the disease. Considering the lack of effective adjuvant therapies after surgery for locally advanced esophageal squamous carcinoma. And with the encouraging preliminary results of PD-1 inhibitors in advanced esophageal squamous cell carcinoma (ESCC), postoperative adjuvant immunotherapy for esophageal squamous carcinoma seems to be feasible. The main objective of this study was the efficacy of postoperative adjuvant therapy with sintilimab in patients with ESCC radically resected after neoadjuvant chemoimmunotherapy.

All participants who meet the inclusion criteria will be enrolled after signing the informed consent form. A total of 400 patients are to be recruited for the study. 400 subjects were randomly assigned to the two treatment groups. Group A: Postoperative adjuvant sintilimab 200mg fixed dose Q3W, immunotherapy will be administered for a total of 1 year. Group B: Close observation. The primary endpoint is disease-free survival (DFS). The secondary endpoints are postoperative overall survival (OS); 1, 2, and 3-year postoperative OS rates; recurrent metastasis pattern (local recurrence or distant metastasis).

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Phase 3

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, China, 350100

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:

  1. Signed written informed consent prior to the implementation of any trial-related processes;
  2. Male or female, ≥18 years of age or ≤75 years of age;
  3. Pathologically confirmed ESCC in the thoracic segment;
  4. Received 2-4 cycles of neoadjuvant chemoimmunotherapy and assessed by imaging as CR or PR (clinical staging of cT1b-T2,N+ or cT3-T4a,ANY N) (8th edition UICC/AJCC TNM staging);
  5. Underwent radical surgery, and had negative surgical margins confirmed pathologically after surgery (R0), defined as the absence of squamous carcinoma cells from the proximal, distal, or peripheral resection borders of esophageal carcinoma;
  6. Postoperative pathological assessment of non-pCR, and residual tumor in the primary tumor focus or regional lymph nodes.

Exclusion Criteria:

  1. Patients with an untreated diagnosis of another malignancy within 5 years prior to the first dose (excluding radically treated basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or carcinoma in situ that has undergone radical resection);
  2. Serious surgical complications after resection of esophageal cancer with reference to Clavien-Dindo classification > 3;
  3. Individuals with a history of allergy or hypersensitivity to components of the study drug or severe hypersensitivity to any monoclonal antibody;
  4. All toxicities (other than nephropathy, neuropathy, hearing loss, alopecia, and fatigue) attributable to prior antitumor therapy (preoperative induction therapy) must have recovered to baseline levels or Grade 1 (CTCAE Version 5.0) prior to administration of study drug;
  5. Received systemic therapy with a proprietary medicine with an antitumor indication or an immunomodulatory drug (including thymidine, interferon, interleukin, except for local use to control pleural fluid) within 2 weeks prior to the first dose;
  6. Women who are pregnant or breastfeeding;
  7. Presence of any serious or uncontrollable systemic disease.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Postoperative adjuvant sintilimab 200mg fixed dose Q3W, immunotherapy will be administered for a total of 1 year.
Drug: sintilimab
200mg fixed dose Q3W,1 year
No Intervention: Group B
Close observation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disease-free survival (DFS)
Time Frame: 2 years
disease-free survival (the time from the date of randomization to the first date of disease recurrence or death, whichever occurred first, before subsequent anticancer therapy).DFS for 400 participants.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative overall survival (OS)
Time Frame: 2 years
The postoperative overall survival (OS) was defined as the time from primary tumor resection (surgical date) to last follow-up or death.OS for 400 participants.
2 years
1, 2, and 3-year postoperative OS
Time Frame: 1, 2, and 3-year
1, 2, and 3-year postoperative OS for 400 participants.
1, 2, and 3-year
recurrent metastasis pattern
Time Frame: two-year period
recurrent metastasis pattern (local recurrence or distant metastasis) for 400 participants.
two-year period

Collaborators and Investigators

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

Sponsor

Fujian Medical University Union Hospital

Investigators

  • Study Chair: Maohui Chen, Fujian Medical University Union 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 (Estimated)

January 10, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

November 22, 2023

First Submitted That Met QC Criteria

November 30, 2023

First Posted (Estimated)

December 8, 2023

Study Record Updates

Last Update Posted (Estimated)

December 8, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POSLS-union02

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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