NCT06354140 PPIO-008 Tislelizumab Combined With S-1 in Patients With ypT+N0 ESCC After Radical Resection With Neoadjuvant STUDY
| NCT ID | NCT06354140 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Daping Hospital and the Research Institute of Surgery of the Third Military Medical University |
| Condition | Esophageal Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2024-05-07 |
| Primary Completion | 2027-05-30 |
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.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 45 participants in total. It began in 2024-05-07 with a primary completion date of 2027-05-30.
⚠ 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
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
Eligibility Criteria
Inclusion Criteria: 1. Age 18-75 years old, gender is not limited; 2. Patients with esophageal squamous cell carcinoma with neoadjuvant immunotherapy combined with chemotherapy (radiotherapy was not planned during the study period); 3. Thoracic esophageal squamous cell carcinoma patients with residual pathologic primary site and lymph node positive (ypT1-4aN0M0) after surgery (8th UICC-TNM stage); 4. The operation was radical resection; 5. Physical status ECOG 0 \~ 1 score; 6. No local recurrence or distant metastasis was found in the examination before postoperative adjuvant treatment; 7. There were no contraindications of chemotherapy or immunotherapy in the evaluation of various organ functions; 8. Understand and sign the informed consent. Exclusion Criteria: 1. 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). 2. Prior history of interstitial lung disease, or pneumonia requiring steroid treatment when enrolled; 3. Receiving systemic steroid therapy (more than 10mg of prednisone per day or equivalent) or other immunosuppressant within 2 weeks prior to randomization; 4. People who have been severely allergic to chemotherapy drugs (fluorouracil) or any monoclonal antibody; 5. Patients with active autoimmune diseases; 6. Patients with active hepatitis 7. According to the judgment of the researcher, there are other circumstances that are not suitable for participation in this study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06354140 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 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 NCT06354140 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06354140 currently recruiting?
Yes, NCT06354140 is actively recruiting participants. Contact the research team at gyguowei@hotmail.com for enrollment information.
Where is the NCT06354140 trial being conducted?
This trial is being conducted at Chongqing, China.
Who is sponsoring the NCT06354140 clinical trial?
NCT06354140 is sponsored by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University. The trial plans to enroll 45 participants.