NCT05536102 The Effectiveness and Safety of XELOX and Tislelizumab + PLD for Resectable Gastric Cancer (LidingStudy)
| NCT ID | NCT05536102 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine |
| Condition | Gastric Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 38 participants |
| Start Date | 2022-09-05 |
| Primary Completion | 2023-09-30 |
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 38 participants in total. It began in 2022-09-05 with a primary completion date of 2023-09-30.
⚠ 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
This is a signle-arm, multi-center, open-lable, phase II study. The objective is to evaluate the effectiveness and safety of tislelizumab + oxaliplatin + capecitabine + PLD in the neoadjuvant treatment of resectable gastric adenocarcinoma.
Eligibility Criteria
Inclusion Criteria: 1. Age: 18\~75 years old. 2. Karnofsky Performance Status Score ≥70. 3. Histological or cytological diagnosed as gastric adenocarcinoma, HER2-, PD-1/L1+. 4. Clinical stage stage III (8th edition of the AJCC Cancer Staging Manual). 5. Physical condition and organ function allow for larger abdominal surgery. 6. Subject baseline blood routine and biochemical indicators meet the following standards: hemoglobin ≥90g/L; absolute neutrophil count (ANC) ≥1.5×10\^9g/L; platelets counts (PLT) ≥100×10\^9/L; alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal (ULN); serum total bilirubin \<1.5 ULN; serum creatinine \<1 ULN; serum albumin ≥30g/L. 7. Heart function: 1. Left ventricular ejection fraction (LVEF) ≥50%; 2. 12-ECG indicates no myocardial ischemia; 3. No history of arrhythmia requiring drug intervention before enrollment; 8. No serious concomitant diseases that make the survival time \< 5 years. 9. Agree and be able to comply with the protocol during the study period. 10. Provide written informed consent before entering the study. Exclusion Criteria: 1. Received chemotherapy, radiotherapy or immunotherapy for this gastric cancer. 2. Pregnant or breastfeeding women. 3. Women of childbearing age who had a positive pregnancy test at baseline or who did not have a pregnancy test. Menopausal women must have menopause for at least 12 months before they can become pregnant. 4. Men and women who are sexually active (possible to have children) are unwilling to use contraception during the study period. 5. Patients with mass ascites and positive abdominal free cancer cells. 6. With a history of other malignancies in the last 5 years, except for cured non-melanoma skin cancer and cervical carcinoma in situ. 7. With a history of epilepsy, central nervous system disease, or mental disorder may be judged by the investigator that their clinical severity may hinder the signing of informed consent or affect the patient's oral medication compliance. 8. Clinically severe (i.e. active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) grade II or more severe congestive heart failure, or severe arrhythmia requiring medical intervention, or the last 12 There was a history of myocardial infarction within months. 9. Patients deficiency of dihydropyrimidine dehydrogenase (DPD). 10. Peripheral nerve disease ≥ NCI CTC AE grade 2. However, the patients only with deep tendon reflex (DTR) disappears do not need to be excluded. 11. Organ transplantation requires immunosuppressive therapy. 12. Severe uncontrolled repeated infections, or other serious uncontrolled concomitant diseases. 13. Moderate or severe renal damage \[creatinine clearance ≤50ml/min (calculated according to Cockroft and Gault equation), or serum creatinine\> ULN\]. 14. Acute or chronic active hepatitis B, hepatitis C infection, hepatitis B virus (HBV) DNA\>2000IU/ml or 10\^4 copies/ml, hepatitis C virus (HCV) RNA\>10\^3 copies/ml, hepatitis B surface antigen (HbsAg) is positive at the same time as anti-HCV antibody. 15. Allergic to any research drug ingredients. 16. Participating in other trials within 4 weeks before enrollment. 17. Not suitable to participate in this trial for any reason judged by the investigator.
Contact & Investigator
Qi Li
STUDY CHAIR
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Frequently Asked Questions
Who can join the NCT05536102 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 NCT05536102 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 NCT05536102 currently recruiting?
Yes, NCT05536102 is actively recruiting participants. Contact the research team at Leeqi2001@hotmail.com for enrollment information.
Where is the NCT05536102 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT05536102 clinical trial?
NCT05536102 is sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine. The principal investigator is Qi Li at Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine. The trial plans to enroll 38 participants.
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