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NCT Number: NCT05984342

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

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.

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Key information

Conditions

Esophageal Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cancer Hospital of Shantou University Medical College

Shantou, Guangdong, 515031, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged between 18 and 70 years
  • Untreated before surgery (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy)
  • Histologically documented squamous cell carcinoma of the thoracic esophagus with positive lymph nodes （T1-3N1-3M0）
  • undergoing radical esophagectomy
  • ECOG (Eastern Cooperative Oncology Group) : 0-1
  • No recurrent disease before adjuvant therapy
  • Normal hemodynamic indices before the recruitment
  • Able to understand this study and have signed informed consent

Exclusion criteria

  • previous or concurrent malignancy
  • Interstitial lung disease
  • Requiring systemic treatment with either corticosteroids or other immunosuppressive medications
  • Known or suspected allergy to chemotherapeutic drugs or Tislelizumab
  • Active autoimmune disease
  • Active hepatitis
  • Those whom the investigator considered unsuitable for inclusion

Treatment and study plan

Tislelizumab

Drug

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

Primary outcomes

  1. disease-free survival rate

    Time frame: 1 years after surgery

    disease free survival after surgery

Secondary outcomes

  1. Rate of adverse events

    Time frame: within 6 months

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

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Affiliated Cancer Hospital of Shantou University Medical College

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2029
First posted
Aug 9, 2023
Registry last updated
Aug 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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