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Trial Title:
The Effectiveness and Safety of XELOX and Tislelizumab + PLD for Resectable Gastric Cancer (LidingStudy)
NCT ID:
NCT05536102
Condition:
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Doxorubicin
Liposomal doxorubicin
Capecitabine
Oxaliplatin
Tislelizumab
Conditions: Keywords:
PLD
resectable
XELOX
PD-1
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
PLD
Description:
20mg/m2, day 1, q3w
Arm group label:
Experiment group
Other name:
Pegylated Liposomal Doxorubicin
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
130 mg/m2, day 1, q3w
Arm group label:
Experiment group
Other name:
Eloxatin
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
1000 mg/m2, days 1-14, q3w
Arm group label:
Experiment group
Other name:
Xeloda
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
200 mg, day 1, q3w
Arm group label:
Experiment group
Other name:
BGB-A317
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.
Detailed description:
This single-arm, multicenter, open-label study plan to enroll patients with resectable
stage III gastric adenocarcinoma to recieve tislelizumab + oxaliplatin + capecitabine +
PLD regimen for 2 or 4 cycles, radical resection will be performed after neoadjuvant
therapy. Radiological evaluation will be performed every 2 cycles to evaluate the
resectability of tumor. Survival follow-up will be performed after surgery, until
patient's withdrawal of informed consent, loss to follow-up or death, whichever comes
first.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai General Hospital
Address:
City:
Shanghai
Zip:
200080
Country:
China
Status:
Recruiting
Contact:
Last name:
Jingyi Zhou, Dr.
Phone:
15618122509
Email:
jingyi_z2020@sjtu.edu.cn
Investigator:
Last name:
Haiyan Zhang, MD.
Email:
Sub-Investigator
Start date:
September 5, 2022
Completion date:
September 30, 2027
Lead sponsor:
Agency:
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Agency class:
Other
Source:
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05536102
