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Gastric Cancer Stage IIIB-IIICPhase 2NCT06036745

Exploratory Single-arm, Single-center Adjuvant Treatment of Stage IIIB-IIIC Gastric Cancer With Combination of Palizumab and SOX Regimen

A Phase 2 study testing Pembrolizumab + SOX in people with Gastric Cancer Stage IIIB-IIIC, run by Shanghai Minimally Invasive Surgery Center at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

it is an an Exploratory Single-Arm, Single-Center Study of Pembrolizumab in Combination with SOX Regimen for Adjuvant Treatment of Stage IIIB-IIIC Gastric Cancer Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Gastric Cancer Stage IIIB-IIIC
What is being tested?
Pembrolizumab + SOX
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
1 Jul 2022to 1 Jul 2026
Phase
Phase 2
Are there results?
None posted in the registry

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

  • 1. Subjects voluntarily join the study and sign an informed consent form; 2. Male or female patients between the ages of 18-75; 3. Adenocarcinoma of the gastric/esophagogastric junction after radical resection was staged at stage IIIB-IIIC; 4. The molecular pathology of gastric cancer must meet at least one of the following three conditions:
  • Consistent with high-frequency microsatellite instability MSI-H
  • Consistent with high tumor mutation load TMB-H (≥10 mutations/megabases)
  • High expression of PD-L1 (CPS score ≥5) 5. Expected survival time > 6 months； 6. ECOG (Eastern US Cooperative Oncology Group) score: 0-1 points; 7. Have not received anti-tumor immunotherapy; 8. Agree to provide archived tumor tissue samples for molecular testing; 9. Have good organ function:
  • <!-- -->
  • Hemoglobin ≥90g/L;
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  • Absolute neutrophil count ≥1.5×109/ L;
  • Platelet count ≥100×109/ L;
  • aspartate or alanine aminotransferase ≤ 2.5 times the upper limit;
  • alkaline phosphatase ≤ 2.5 times the upper normal limit ; 10. Women of reproductive age who need to use a medically approved contraceptive method (such as an IUD, contraceptive pill, or condom) during the study treatment period and for 3 months after the end of the study treatment period; For men who agreed to use an appropriate method of contraception during the trial and for 3 months after the last dose of the trial drug.
  • 11. Women of reproductive age must be negative for serum or urine HCG within 72 hours prior to study entry. And must be non-lactating.

Who cannot join

  • <!-- -->
  • Patients with severe hypertension and poor drug control;
  • Patients with difficulty in taking oral drugs due to dysphagia, complete or incomplete digestive tract obstruction, active gastrointestinal bleeding, perforation, etc.;
  • People who are known to be allergic to the ingredients in the test drug or have metabolic disorders;
  • Simultaneously participating in other tumor experimental drugs or being in other tumor clinical trials.
  • Severe liver disease (such as cirrhosis, etc.), kidney disease, respiratory disease or uncontrollable diabetes, hypertension and other chronic system diseases; Clinically obvious heart disease, such as congestive heart failure, obvious coronary heart disease, medically difficult to control arrhythmia, hypertension, or myocardial infarction within 6 months, or cardiac insufficiency;
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  • Patients with peripheral nervous system disorders or a history of obvious mental disorders and central nervous system disorders;
  • Diagnosed with immunodeficiency or received systemic hormone therapy or other forms of immunosuppressive therapy within 7 days prior to initial administration;
  • Active period \&gt; CTCAE (Version 5.0) grade 2 clinical severe infection;
  • Pregnant and lactating women, women of childbearing age and their spouses refuse to take effective contraceptive methods;
  • Persons without legal capacity, whose medical or ethical reasons affect the continuation of the research.
  • Other conditions determined by the investigator to be unsuitable for inclusion in the study.

Trial locations and contacts

1 site in 1 country.

Zhenghao Cai contact

17316533505

c3z2h1@alumni.sjtu.edu.cn

China1 site, 1 recruiting

  • Ruijin Hospital

    Shanghai, Shanghai Municipality, 200025

    CAI Zhenghao, 17316533505, c3z2h1@alumni.sjtu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: An Exploratory Single-Arm, Single-Center Study of Pembrolizumab in Combination With SOX Regimen for Adjuvant Treatment of Stage IIIB-IIIC Gastric Cancer

it is an an Exploratory Single-Arm, Single-Center Study of Pembrolizumab in Combination with SOX Regimen for Adjuvant Treatment of Stage IIIB-IIIC Gastric Cancer

Being tested
Pembrolizumab + SOX
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • Pembrolizumab + SOXDrug

    Pembrolizumab 200mg, ivdrip, q3w; Oxaliplatin 135mg/m2, ivdrip，q3w; Trastuzumab 40 mg/m2，po bid，d1~d14，q21d. Each cycle consists of three weeks, totaling eight cycles

Study groups in NCT06036745
Study groupRoleWhat they receive
Pembrolizumab + SOXExperimentalNot described
Receives: Drug: Pembrolizumab + SOX

What is being measured

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

  1. Disease-free survival

    the time from the start of surgery to the incurable resection, local recurrence or metastasis, or death from any cause.

    Measured: 3 years

Secondary outcomes (3)

  1. Overall survival

    the time from the start of surgery to death due to any cause.

    Measured: 3 years

  2. perioperative complications

    perioperative complications

    Measured: the time from the start of enrollment to 3 months after surgery

  3. Adverse Events

    occurs after a clinical trial subject receives a drug, but is not necessarily causally related to the treatment.

    Measured: the time from the start of enrollment to 90 days after using drugs/ 30 days after surgery

Timeline

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

  1. First posted14 Sep 2023
  2. Study start1 Jul 2022
  3. Primary completion1 Jul 2023
  4. Study completion1 Jul 2026 (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
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06036745
Sponsor's protocol ID
Adjuvant K+SOX
Status last verified
Mar 2024
First submitted
7 Sep 2023
Last updated
7 Mar 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab + SOX in people with Gastric Cancer Stage IIIB-IIIC, run by Shanghai Minimally Invasive Surgery Center 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 11 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 7 Mar 2024. 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?

Results are not available in the source record.

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

Contact Zhenghao Cai (17316533505, c3z2h1@alumni.sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free survival (time frame: 3 years). 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 NCT06036745.

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 7 Mar 2024.

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