NCT06354140RecruitingPhase 2
PPIO-008 Tislelizumab Combined With S-1 in Patients With ypT+N0 ESCC After Radical Resection With Neoadjuvant STUDY
The Efficacy of Tislelizumab Combined With S-1 in Patients With Residual Primary Lesions and Node-Negative Esophageal Squamous Cell Carcinoma After Neoadjuvant Immunochemotherapy Followed by Curative Resection: A Phase II, Multicenter Trial
Source: ClinicalTrials.gov · Last updated 17 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- First submitted
- 3 Apr 2024
- Start date
- 7 May 2024
- Primary completion date
- 30 May 2027
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06354140
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 45
- From 7 May 2024 to the primary completion date, 30 May 2027
- 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
- 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;
Other illness
- People who have been severely allergic to chemotherapy drugs (fluorouracil) or any monoclonal antibody;
- Patients with active autoimmune diseases;
- Patients with active hepatitis
Other
- According to the judgment of the researcher, there are other circumstances that are not suitable for participation in this study.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 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 |
|---|---|---|---|
| Army Medical Center of the People's Liberation Army Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.