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Adjuvant Chemotherapy in Combination With Tislelizumab in Lymph Node-Positive Esophageal Squamous Cell Carcinoma

Sponsor
Affiliated Cancer Hospital of Shantou University Medical College (Other)
Overall Status
Recruiting
CT.gov ID
NCT05984342
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
70.9
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Esophageal cancer is one of the most common malignancies in China, and esophageal squamous cell carcinoma (ESCC) is the predominant histological type. Surgical resection is still a standard therapeutic approach for patients with resectable ESCC, but the prognosis is still disappointing. Although neoadjuvant chemoradiotherapy plus surgery is currently recommended for patients with locally advanced ESCC, it is still an infrequently used procedure in China. The efficacy of adjuvant therapy on ESCC is still controversial. Recently, the CheckMate 577 trial showed that adjuvant nivolumab therapy could improve DFS for patients with residual disease after neoadjuvant chemoradiotherapy plus surgery. However, no optimal postoperative adjuvant therapy was recommended for patients with ESCC received upfront surgery. We designed a prospective randomized controlled tial to study whether immunotherapy could be used with chemotherapy after surgery to improve overall survival in these patients. The primary endpoint of the study is disease free survival, with secondary endpoints of overall survival, safety and toxicity, and quality of life.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Adjuvant Chemotherapy in Combination With Tislelizumab in Lymph Node-Positive Esophageal Squamous Cell Carcinoma
Anticipated Study Start Date :
Aug 2, 2023
Anticipated Primary Completion Date :
Jun 30, 2025
Anticipated Study Completion Date :
Jun 30, 2029

Arms and Interventions

Arm Intervention/Treatment
Experimental: Adjuvant Chemotherapy in Combination With Immunotherapy

Adjuvant Chemotherapy in Combination With Tislelizumab was used in patients with Lymph Node-Positive Esophageal Squamous Cell Carcinoma after surgery

Drug: Tislelizumab
Adjuvant Chemotherapy （nab-paclitaxel 260mg/m2 d1 plus Cisplatin 75mg/m2 d1 or 25mg/m2 d1-3) in combination with Tislelizumab (200 mg Q3W)
Other Names:
  • nab-paclitaxel
  • Cisplatin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. disease-free survival rate [1 years after surgery]

      disease free survival after surgery

    Secondary Outcome Measures

    1. Rate of adverse events [within 6 months]

      Rate of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI- CTCAE v5.0)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Aged between 18 and 70 years

    2. Untreated before surgery (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy)

    3. Histologically documented squamous cell carcinoma of the thoracic esophagus with positive lymph nodes （T1-3N1-3M0）

    4. undergoing radical esophagectomy

    5. ECOG (Eastern Cooperative Oncology Group) : 0-1

    6. No recurrent disease before adjuvant therapy

    7. Normal hemodynamic indices before the recruitment

    8. Able to understand this study and have signed informed consent

    Exclusion Criteria:

    1. previous or concurrent malignancy

    2. Interstitial lung disease

    3. Requiring systemic treatment with either corticosteroids or other immunosuppressive medications

    4. Known or suspected allergy to chemotherapeutic drugs or Tislelizumab

    5. Active autoimmune disease

    6. Active hepatitis

    7. Those whom the investigator considered unsuitable for inclusion

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cancer Hospital of Shantou University Medical College Shantou Guangdong China 515031

    Sponsors and Collaborators

    • Affiliated Cancer Hospital of Shantou University Medical College

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shao-bin Chen, Professor, Affiliated Cancer Hospital of Shantou University Medical College
    ClinicalTrials.gov Identifier:
    NCT05984342
    Other Study ID Numbers:
    • 2023045
    First Posted:
    Aug 9, 2023
    Last Update Posted:
    Aug 9, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Shao-bin Chen, Professor, Affiliated Cancer Hospital of Shantou University Medical College
    esophageal squamous cell carcinoma
    immunotherapy
    chemotherapy
    surgery
    adjuvant therapy
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Squamous Cell
    Esophageal Squamous Cell Carcinoma
    Paclitaxel
    Cisplatin
    Tislelizumab

    Study Results

    No Results Posted as of Aug 9, 2023