NCT05687357 Tislelizumab in Combination With Pre-operative CRT Versus SOC for Locally Advanced G/GEJ Adenocarcinoma
| NCT ID | NCT05687357 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
| Condition | Gastric Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2023-03-15 |
| Primary Completion | 2027-02-28 |
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 140 participants in total. It began in 2023-03-15 with a primary completion date of 2027-02-28.
⚠ 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
The purpose of this study is to evaluate the efficacy of Tislelizumab in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma. The primary study hypotheses are that: Neoadjuvant and adjuvant Tislelizumab plus chemoradiotherapy, followed by adjuvant Tislelizumab and chemotherapy is superior to neoadjuvant chemoradiotherapy or chemotherapy, followed by adjuvant chemotherapy in terms of rate of Pathological Complete Response (pathCR) at the time of surgery.
Eligibility Criteria
Inclusion Criteria: 1. Has previously untreated localized gastric or GEJ adenocarcinoma as defined by T3\~4aN+M0 or T4bNanyM0 （AJCC Version 8） 2. Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1 3. Has adequate organ function. 4. Male participants of childbearing potential must agree to use an adequate method of contraception for the course of the study through 180 days after the last dose of chemotherapy. 5. Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is greater. Exclusion Criteria: 1. Has a known additional malignancy that is progressing or has required active treatment within the past 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ that have undergone potentially curative therapy are not excluded. 2. Has received prior systemic anti-cancer therapy including investigational agents for the current malignancy. 3. Has an active infection requiring systemic therapy. 4. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. 5. Is currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment. 6. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 14 days prior the first dose of study treatment. 7. Has an active autoimmune disease that has required systemic treatment in past 2 years. 8. Has a known history of human immunodeficiency virus (HIV) infection. 9. Has a known history of Hepatitis B or known active Hepatitis C virus infection (HBsAg positive with HBV DNA≥500 IU/ml；HCV：HCV antigen positive with HCV copies \>ULN). 10. Has had an allogenic tissue/solid organ transplant. 11. Has received a live vaccine within 30 days prior to the first dose of study treatment. 12. Female participants who are breastfeeding.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05687357 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Gastric Cancer. 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 NCT05687357 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 NCT05687357 currently recruiting?
Yes, NCT05687357 is actively recruiting participants. Contact the research team at jiawei99@nju.edu.cn for enrollment information.
Where is the NCT05687357 trial being conducted?
This trial is being conducted at Wuhan, China, Nanjing, China, Taiyuan, China.
Who is sponsoring the NCT05687357 clinical trial?
NCT05687357 is sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. The trial plans to enroll 140 participants.
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