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Gastric CancerPhase 2NCT05536102

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

A Phase 2 study testing PLD, Oxaliplatin and Capecitabine in people with Gastric Cancer, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Gastric Cancer
What is being tested?
PLD, Oxaliplatin and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteChina
Study dates
5 Sep 2022to 30 Sep 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • Heart function:
  • Left ventricular ejection fraction (LVEF) ≥50%;
  • 12-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.

Who cannot join

  • 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.
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  • 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.
  • Participating in other trials within 4 weeks before enrollment.
  • Not suitable to participate in this trial for any reason judged by the investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Qi Li, Prof. contact

13818207333

Leeqi2001@hotmail.com

China1 site, 1 recruiting

  • Shanghai General Hospital

    Shanghai, 200080

    Jingyi Zhou, Dr., 15618122509, jingyi_z2020@sjtu.edu.cn

    Haiyan Zhang, MD.

    Recruiting

Other trials in China

About this study

Official title: 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 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.

Read the 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.

Conditions
Gastric Cancer
Keywords
PLD, resectable, XELOX, PD-1
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PLDDrug

    Also called Pegylated Liposomal Doxorubicin

    20mg/m2, day 1, q3w

  • OxaliplatinDrug

    Also called Eloxatin

    130 mg/m2, day 1, q3w

  • CapecitabineDrug

    Also called Xeloda

    1000 mg/m2, days 1-14, q3w

  • TislelizumabDrug

    Also called BGB-A317

    200 mg, day 1, q3w

Study groups in NCT05536102
Study groupRoleWhat they receive
Experiment groupExperimentalPegylated Liposomal Doxorubicin + Oxaliplatin + Capecitabine + Tislelizumab; reapt every 21 days.
Receives: Drug: PLD; Drug: Oxaliplatin; Drug: Capecitabine; Drug: Tislelizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 4-month

Secondary outcomes (5)

  1. Objective response rate

    Defined as the proportion of subjects whose best overall response is complete response (CR) and partial response (PR).

    Measured: 3-month

  2. R0 resection rate

    Defined as the proportion of patients who have achieved R0 resection. R0 surgery is defined as complete resection of the tumor without visible residual lesions either by naked eyes or under microscope.

    Measured: 4-month

  3. 3-year overall survival rate

    Overall survival (OS) is defined as the time from the enrollment to death for any cause. The Kaplan-Meier curve of OS will be proformed to calculted the 3-year OS rate.

    Measured: 3-year

  4. Progress-free survival

    1. In patients who underwent radical surgery, the time from enrollment to recurrence or death; 2) in patients who did not undergo radical surgery, the time from enrollment to progression (according to RECIST 1.1) or death determined as disease progression.

    Measured: 3-year

  5. 3-year PFS rate

    The Kaplan-Meier curve of progress-free survival will be proformed to calculted the 3-year PFS rate.

    Measured: 3-year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2022
  2. Study start5 Sep 2022
  3. Primary completion30 Sep 2023 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05536102
Sponsor's protocol ID
CSPC-DMS-GC-04
Status last verified
Mar 2023
First submitted
7 Sep 2022
Last updated
9 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PLD, Oxaliplatin and Capecitabine in people with Gastric Cancer, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Qi Li, Prof. (13818207333, Leeqi2001@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete remission rate (time frame: 4-month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05536102.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2023.

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