Evaluating a new treatment for resectable gastric cancer

A Single-arm, Open-label, Multicenter Phase 2 Study to Evaluate XELOX + Tislelizumab in Combination With Doxorubicin Hydrochloride Liposome Injection （XELOX+PD-1+PLD）as Neoadjuvant Therapy for Resectable Gastric Cancer

This study is testing a new combination treatment for people with early-stage gastric cancer to see if it helps shrink tumors before surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, tislelizumab
• Locations: 1 site (Shanghai)
• Trial ID: NCT05536102 on ClinicalTrials.gov

What this trial studies

This is a single-arm, multicenter, open-label phase II study aimed at assessing the effectiveness and safety of a combination therapy involving tislelizumab, oxaliplatin, capecitabine, and PLD in patients with resectable stage III gastric adenocarcinoma. Participants will receive the treatment for 2 to 4 cycles before undergoing radical surgical resection. Radiological evaluations will be conducted every two cycles to determine tumor resectability, and patients will be followed for survival outcomes post-surgery until they withdraw consent, are lost to follow-up, or pass away.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with resectable stage III gastric adenocarcinoma who meet specific health criteria.

Not a fit: Patients with serious concomitant diseases or those whose survival is estimated to be less than 5 years may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve surgical outcomes and survival rates for patients with resectable gastric cancer.

How similar studies have performed: Other studies have shown promise with similar combination therapies in treating gastric cancer, indicating potential for success in this approach.

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.

Where this trial is running

Shanghai

• Shanghai General Hospital — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Qi Li, Prof.

Conditions Gastric Cancer; PLD; resectable; XELOX; PD-1