NCT05984342 Adjuvant Chemotherapy in Combination With Tislelizumab in Lymph Node-Positive Esophageal Squamous Cell Carcinoma
| NCT ID | NCT05984342 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Affiliated Cancer Hospital of Shantou University Medical College |
| Condition | Esophageal Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-08-02 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 50 participants in total. It began in 2023-08-02 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT05984342 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Esophageal Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05984342 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05984342 currently recruiting?
Yes, NCT05984342 is actively recruiting participants. Visit ClinicalTrials.gov or contact Affiliated Cancer Hospital of Shantou University Medical College to inquire about joining.
Where is the NCT05984342 trial being conducted?
This trial is being conducted at Shantou, China.
Who is sponsoring the NCT05984342 clinical trial?
NCT05984342 is sponsored by Affiliated Cancer Hospital of Shantou University Medical College. The trial plans to enroll 50 participants.