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Trial Title:
Adjuvant Chemotherapy in Combination With Tislelizumab in Lymph Node-Positive Esophageal Squamous Cell Carcinoma
NCT ID:
NCT05984342
Condition:
Esophageal Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Paclitaxel
Cisplatin
Tislelizumab
Conditions: Keywords:
esophageal squamous cell carcinoma
immunotherapy
chemotherapy
surgery
adjuvant therapy
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
Adjuvant Chemotherapy （nab-paclitaxel 260mg/m2 d1 plus Cisplatin 75mg/m2 d1 or 25mg/m2
d1-3) in combination with Tislelizumab (200 mg Q3W)
Arm group label:
Adjuvant Chemotherapy in Combination With Immunotherapy
Other name:
nab-paclitaxel
Other name:
Cisplatin
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Hospital of Shantou University Medical College
Address:
City:
Shantou
Zip:
515031
Country:
China
Status:
Recruiting
Contact:
Last name:
Shao-bin Chen
Phone:
+8613417000759
Email:
chensb535176@hotmail.com
Start date:
August 2, 2023
Completion date:
June 30, 2029
Lead sponsor:
Agency:
Affiliated Cancer Hospital of Shantou University Medical College
Agency class:
Other
Source:
Affiliated Cancer Hospital of Shantou University Medical College
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05984342
