Conversion of Tislelizumab Combined With Chemotherapy in Unresectable Esophageal Squamous Cell Carcinoma

Last updated: July 7, 2022
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Squamous Cell Carcinoma

Esophageal Cancer

Esophageal Disorders

Treatment

N/A

Clinical Study ID

NCT05449483
E20220333A
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Whether the introduction of immunotherapy can transform unresectable esophageal cancer into resectable, or even achieve R0 surgical resection, has not been reported yet. We plan to conduct a prospective, single-center, single-arm phase II clinical study of the safety and efficacy of tislelizumab combined with chemotherapy in the treatment of unresectable esophageal squamous cell carcinoma.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Histologically confirmed esophageal squamous cell carcinoma;
  2. Unresectable cT4a/N3(stage ⅣA) (AJCC 8 TNM classification);
  3. Have a performance status of 0 or 1 on the ECOG Performance Scale;
  4. Age 18-75 years old, both men and women;
  5. Be willing and able to provide written informed consent/assent for the trial;
  6. Demonstrate adequate organ function, all screening labs should be performed within 10days of treatment initiation;
  7. Female subjects of childbearing potential should have a negative urine or serumpregnancy within 72 hours before receiving the study medication's first dose. If theurine test is positive or cannot be confirmed as unfavorable, a serum pregnancy testwill be required;
  8. Be willing to provide tissue from a newly obtained core or excisional biopsy of atumor lesion through repeated biopsies. Newly acquired is defined as a specimenobtained up to 4 weeks (28 days) prior to initiation of treatment on Day 1. Subjectsfor whom newly-obtained samples cannot be provided (e.g. inaccessible or subjectsafety concern) may submit an archived specimen only upon agreement from the Sponsor.

Exclusion

Exclusion Criteria:

  1. Prior therapy (operation, radiotherapy, immunotherapy, or chemotherapy) for esophagealcancer;
  2. Ineligibility or contraindication for esophagectomy;
  3. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form ofimmunosuppressive therapy within 7 days prior to the first dose of study drug;
  4. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with the use of disease-modifying agents, corticosteroids, or immunosuppressivedrugs);
  5. Has severe hypersensitivity and adverse events (≥Grade 3) to any PD-1/PD-L1inhibitors.

Study Design

Total Participants: 40
Study Start date:
May 11, 2022
Estimated Completion Date:
June 30, 2025

Study Description

For patients not eligible for R0 resection (defined as locally advanced unresectable esophageal cancer), preoperative treatment can theoretically transform the tumor into a resectable state. The current significance of transformation therapy is to reduce tumor volume and stage to achieve radical resection, eliminate micrometastases, and prevent a postoperative recurrence. There are few studies on the transformation therapy of esophageal squamous cell carcinoma. We plan to conduct a prospective, single-center, single-arm phase II clinical study of the safety and efficacy of tislelizumab combined with chemotherapy in the treatment of T4a/N3 esophageal squamous cell carcinoma.

Connect with a study center

  • Hongjing Jiang

    Tianjin, Tianjin 300060
    China

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.