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

Last updated: November 30, 2023
Sponsor: Fujian Medical University Union Hospital
Overall Status: Active - Not Recruiting

Phase

3

Condition

Esophageal Disorders

Lung Cancer

Esophageal Cancer

Treatment

sintilimab

Clinical Study ID

NCT06161909
POSLS-union02
  • Ages 18-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Signed written informed consent prior to the implementation of any trial-relatedprocesses;
  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 orPR (clinical staging of cT1b-T2,N+ or cT3-T4a,ANY N) (8th edition UICC/AJCC TNMstaging);
  5. Underwent radical surgery, and had negative surgical margins confirmed pathologicallyafter surgery (R0), defined as the absence of squamous carcinoma cells from theproximal, distal, or peripheral resection borders of esophageal carcinoma;
  6. Postoperative pathological assessment of non-pCR, and residual tumor in the primarytumor focus or regional lymph nodes.

Exclusion

Exclusion Criteria:

  1. Patients with an untreated diagnosis of another malignancy within 5 years prior to thefirst dose (excluding radically treated basal cell carcinoma of the skin, squamousepithelial carcinoma of the skin, and/or carcinoma in situ that has undergone radicalresection);
  2. Serious surgical complications after resection of esophageal cancer with reference toClavien-Dindo classification > 3;
  3. Individuals with a history of allergy or hypersensitivity to components of the studydrug or severe hypersensitivity to any monoclonal antibody;
  4. All toxicities (other than nephropathy, neuropathy, hearing loss, alopecia, andfatigue) attributable to prior antitumor therapy (preoperative induction therapy) musthave recovered to baseline levels or Grade 1 (CTCAE Version 5.0) prior toadministration of study drug;
  5. Received systemic therapy with a proprietary medicine with an antitumor indication oran immunomodulatory drug (including thymidine, interferon, interleukin, except forlocal 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 Design

Total Participants: 400
Treatment Group(s): 1
Primary Treatment: sintilimab
Phase: 3
Study Start date:
January 10, 2024
Estimated Completion Date:
February 28, 2026

Study 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).

Connect with a study center

  • Fujian

    Fujian, 350100
    China

    Site Not Available

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