The Effectiveness and Safety of XELOX and Tislelizumab + PLD for Resectable Gastric Cancer (LidingStudy)

NCT05536102 | Recruiting Phase 2

• 1 other identifier: CSPC-DMS-GC-04
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Keywords

PLD; resectable; XELOX; PD-1

Outcome Measures

Primary Outcomes (1)

• Pathological complete remission rate

  Completely resected tumor specimens and all sampled regional lymph nodes were detected without residual infiltration (ie ypT0 ypN0 in AJCC staging version 8.0)

  4-month

Secondary Outcomes (5)

• Objective response rate

  3-month

• R0 resection rate

  4-month

• 3-year overall survival rate

  3-year

• Progress-free survival

  3-year

• 3-year PFS rate

  3-year

Other Outcomes (1)

• Adverse events (AEs)

  4-month

Study Arms (1)

Experiment group

EXPERIMENTAL

Pegylated Liposomal Doxorubicin + Oxaliplatin + Capecitabine + Tislelizumab; reapt every 21 days.

Drug: PLD; Drug: Oxaliplatin; Drug: Capecitabine; Drug: Tislelizumab

Interventions

PLD DRUG

20mg/m2, day 1, q3w

Also known as: Pegylated Liposomal Doxorubicin

Experiment group

Oxaliplatin DRUG

130 mg/m2, day 1, q3w

Also known as: Eloxatin

Experiment group

Capecitabine DRUG

1000 mg/m2, days 1-14, q3w

Also known as: Xeloda

Experiment group

Tislelizumab DRUG

200 mg, day 1, q3w

Also known as: BGB-A317

Experiment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18\~75 years old.
• Karnofsky Performance Status Score ≥70.
• Histological or cytological diagnosed as gastric adenocarcinoma, HER2-, PD-1/L1+.
• Clinical stage stage III (8th edition of the AJCC Cancer Staging Manual).
• Physical condition and organ function allow for larger abdominal surgery.
• 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.
• Heart function:
• Left ventricular ejection fraction (LVEF) ≥50%;
• ECG indicates no myocardial ischemia;
• No history of arrhythmia requiring drug intervention before enrollment;
• No serious concomitant diseases that make the survival time \< 5 years.
• Agree and be able to comply with the protocol during the study period.
• Provide written informed consent before entering the study.

You may not qualify if:

• Received chemotherapy, radiotherapy or immunotherapy for this gastric cancer.
• Pregnant or breastfeeding women.
• 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.
• Men and women who are sexually active (possible to have children) are unwilling to use contraception during the study period.
• Patients with mass ascites and positive abdominal free cancer cells.
• With a history of other malignancies in the last 5 years, except for cured non-melanoma skin cancer and cervical carcinoma in situ.
• 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.
• 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.
• Patients deficiency of dihydropyrimidine dehydrogenase (DPD).
• Peripheral nerve disease ≥ NCI CTC AE grade 2. However, the patients only with deep tendon reflex (DTR) disappears do not need to be excluded.
• Organ transplantation requires immunosuppressive therapy.
• Severe uncontrolled repeated infections, or other serious uncontrolled concomitant diseases.
• Moderate or severe renal damage \[creatinine clearance ≤50ml/min (calculated according to Cockroft and Gault equation), or serum creatinine\> ULN\].
• 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.
• Allergic to any research drug ingredients.

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai General Hospital

Shanghai, 200080, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

1-dodecylpyridoxal; liposomal doxorubicin; Oxaliplatin; Capecitabine; tislelizumab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Qi Li

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  STUDY CHAIR

Central Study Contacts

Qi Li, Prof.

CONTACT

13818207333; Leeqi2001@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: September 10, 2022
• Study Start: September 5, 2022
• Primary Completion: September 30, 2023
• Study Completion (Estimated): September 30, 2027
• Last Updated: March 9, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)