NCT05984342RecruitingPhase 1
Adjuvant Chemotherapy in Combination With Tislelizumab in Lymph Node-Positive Esophageal Squamous Cell Carcinoma
Source: ClinicalTrials.gov · Last updated 9 Aug 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 2 Aug 2023
- Start date
- Aug 2023
- Primary completion date
- Jun 2025
- Lead sponsor
- Affiliated Cancer Hospital of Shantou University Medical College
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05984342
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 50
- From Aug 2023 to the primary completion date, Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previous or concurrent malignancy
- Requiring systemic treatment with either corticosteroids or other immunosuppressive medications
Other illness
- Interstitial lung disease
- Known or suspected allergy to chemotherapeutic drugs or Tislelizumab
- Active autoimmune disease
- Active hepatitis
Other
- Those whom the investigator considered unsuitable for inclusion
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cancer Hospital of Shantou University Medical College Coordinator of this site? Confirm its status | Shantou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.