Actively Recruiting
PPIO-008 Tislelizumab Combined With S-1 in Patients With ypT+N0 ESCC After Radical Resection With Neoadjuvant STUDY
Led by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Updated on 2024-07-17
45
Participants Needed
1
Research Sites
212 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To explore the safety and efficacy of Tegafur combined with tislelizumab in patients with esophageal squamous cell carcinoma with residual primary lesion and node-negative after radical resection following neoadjuvant immunotherapy combined with chemotherapy
CONDITIONS
Official Title
PPIO-008 Tislelizumab Combined With S-1 in Patients With ypT+N0 ESCC After Radical Resection With Neoadjuvant STUDY
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-75 years old, gender is not limited;
- Patients with esophageal squamous cell carcinoma with neoadjuvant immunotherapy combined with chemotherapy (radiotherapy was not planned during the study period);
- Thoracic esophageal squamous cell carcinoma patients with residual pathologic primary site and lymph node positive (ypT1-4aN0M0) after surgery (8th UICC-TNM stage);
- The operation was radical resection;
- Physical status ECOG 0 ~ 1 score;
- No local recurrence or distant metastasis was found in the examination before postoperative adjuvant treatment;
- There were no contraindications of chemotherapy or immunotherapy in the evaluation of various organ functions;
- Understand and sign the informed consent.
You will not qualify if you...
- Had malignant tumors other than esophageal cancer within 5 years prior to admission (cured localized tumors were not excluded, including cervical carcinoma in situ, skin basal cell carcinoma and prostate carcinoma in situ, etc.); Prostate cancer patients who received hormone therapy and obtained DFS for more than 5 years were not excluded).
- Prior history of interstitial lung disease, or pneumonia requiring steroid treatment when enrolled;
- Receiving systemic steroid therapy (more than 10mg of prednisone per day or equivalent) or other immunosuppressant within 2 weeks prior to randomization;
- People who have been severely allergic to chemotherapy drugs (fluorouracil) or any monoclonal antibody;
- Patients with active autoimmune diseases;
- Patients with active hepatitis
- According to the judgment of the researcher, there are other circumstances that are not suitable for participation in this study.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Army Medical Center of the People's Liberation Army
Chongqing, Chongqing Municipality, China, 400042
Actively Recruiting
Research Team
W
Wei Guo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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