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Gastric or Gastroesophageal Junction AdenocarcinomaPhase 2NCT05994456

Neoadjuvant Toripalimab for dMMR/MSI-H Gastric Cancer

A Phase 2 study testing PD-1 inhibitor in people with Gastric or Gastroesophageal Junction Adenocarcinoma, run by Sun Yat-sen University 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is a single-center, open phase II clinical trial to evaluate the tolerability, safety and efficacy of toriparib monotherapy in the treatment of locally advanced dMMR/MSI-H gastric or gastroesophageal junction adenocarcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
PD-1 inhibitor
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteChina
Study dates
9 Mar 2023to Dec 2024
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. Aged 18-75 years, regardless of gender 2. Patients with histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction and confirmed dMMR or MSI-H 3. Preoperative CT or MRI staging meeting the following criteria: T2 and above, with or without lymph node involvement, without clear distant metastasis 4. ECOG score of 0-1. 5. Expected survival ≥ 2 years. 6. Good organ function (no blood transfusion, no hematopoietic stimulating factor, no albumin or blood product transfusion within 14 days prior to the examination).
  • Platelet (PLT) count ≥ 90*109/L.
  • Neutrophil count (ANC) ≥ 1.5*109/L.
  • Hemoglobin (Hb) level ≥ 9.0 g/dl.
  • International normalized ratio (INR) ≤ 1.5.
  • Prothrombin time (PT) and active partial thromboplastin time (APTT) ≤ 1.5 x ULN.
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  • Glycated hemoglobin (HbA1c) <7.5%.
  • Total bilirubin (TBIL) level ≤ 1.5 times the upper limit of normal (ULN).
  • Alanine amino transaminase (ALT) and aspartate amino transaminase (AST) levels ≤ 2.5 x ULN.
  • Serum creatinine (Cr) level ≤ 1.5 x ULN and creatinine clearance ≥ 60 ml/min.
  • Thyrotropin (TSH) ≤ ULN; serum free thyroid hormone (T4) normal; serum free triiodothyronine (T3) normal; (except for those who have received previous thyroid surgery or have a history of head and neck radiotherapy)
  • Serum amylase ≤ 1.5 x ULN.
  • Lipase ≤ 1.5×ULN. 7. Women of childbearing age must have a negative pregnancy test and must use contraception and avoid breastfeeding during the study and for 3 months after the last dose; male subjects must agree to use contraception during the study and for 3 months after the last dose.
  • 8.Be able to understand and willing to sign a written informed consent form.

Who cannot join

  • Previously received chemotherapy, radiotherapy or immunotherapy for gastric cancer
  • Previously diagnosed any other malignancy with a primary site or histological type different from gastric cancer within 5 years prior to study entry, except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • With known hypersensitivity to the study drug or excipients, or to similar drugs
  • Received major surgery or open biopsy, or had a major trauma within 4 weeks prior to the start of study treatment
  • Received immunosuppressive drugs (excluding inhaled corticosteroids or ≤10 mg/day prednisone or equivalent pharmacophysiologic doses of other systemic steroids) within 2 weeks prior to the start of study treatment
  • Planned live attenuated vaccination within 4 weeks prior to the start of study treatment or during the study period
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  • Inability to discontinue CYP3A4 inducers or inhibitors within 1 week prior to the start of study treatment and during the study period
  • Presence of any autoimmune disease or history of autoimmune disease.
  • Human immunodeficiency virus (HIV) infection (HIV antibody positive), or active hepatitis C virus (HCV) infection (HCV antibody positive), or active hepatitis B virus (HBV) infection (HBsAg positive and HBV-DNA ≥ 2000 IU/ml copies/ml)), or other serious infection requiring antibiotics for systemic therapy, or during screening/study Unexplained temperature >38.5°C prior to the start of treatment.
  • Presence of the following diseases within 6 months prior to the start of study treatment: myocardial infarction, severe/unstable angina, NYHA class 2 or higher congestive heart failure, poorly controlled arrhythmias, etc.
  • Non-well-controlled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg under optimal treatment)
  • Arterial/venous thrombotic events such as cerebrovascular accidents (transient ischemic attack, cerebral hemorrhage, cerebral infarction, etc.), deep vein thrombosis, vasculitis, etc. within 3 months prior to the start of study treatment
  • Urine routine suggesting urine protein up to +++ and confirmed 24-hour urine protein quantification up to 1.0g.
  • The presence of a history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
  • Seizures requiring medication (e.g., steroids or antiepileptic drugs) for treatment.
  • Presence of a history of substance abuse, drug use, or alcohol dependence. Patients with other serious, acute or chronic medical conditions that may increase the risk of study participation and study medication, or that may interfere with the interpretation of study results, and who are judged by the investigator to be unsuitable for participation in a clinical trial.

Trial locations and contacts

1 site in 1 country.

Dongsheng Zhang, PhD contact

86-2087343795

zhangdsh@sysucc.org.cn

China1 site, 1 recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou

    Dongsheng Zhang, Dr., +8602087343560, zhangds@sysucc.org.cn

    Zhang

    Recruiting

Other trials in China

About this study

Official title: Neoadjuvant Toripalimab in the Treatment of Locally Advanced dMMR/MSI-H Gastric or Gastroesophageal Junction Adenocarcinoma：an Open-label, Single-arm，Multi-center，Phase II Trial

This is a single-center, open phase II clinical trial to evaluate the tolerability, safety and efficacy of toriparib monotherapy in the treatment of locally advanced dMMR/MSI-H gastric or gastroesophageal junction adenocarcinoma.

Read the detailed description

In this phase II study, eligible patients are enrolled to receive toripalimab 240mg, ivdrip, Q3W to evaluate the anti-tumor efficacy and safety. After 2 and 4 cycles of toripalimab treatment, tumors are assessed, and patients are assigned to receive surgery or withdraw from study according to their anti-tumor efficacy. For patients withdrawing from study, routine treatment would be given. For patients staying in study, toripalimab would be administered for up to 2 years.

Being tested
PD-1 inhibitor
Keywords
dMMR/MSI-H, Gastric cancer
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • PD-1 inhibitorDrug

    Also called Toripalimab

    240mg, Q3W. The opportunity for surgery was evaluated after 2 cycles of treatment and surgical treatment was performed after 2-4 cycles of treatment. Postoperatively, adjuvant therapy was continued according to the neoadjuvant regimen, and direct treatment met the criteria for termination of treatment.

Study groups in NCT05994456
Study groupRoleWhat they receive
PD-1 inhibitorExperimentalNeoadjuvant therapy with PD-1 inhibitor (Toripalimab)
Receives: Drug: PD-1 inhibitor

What is being measured

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

  1. Pathological complete remission (pCR) rates

    Percentage of patients who achieve pathological complete remission (pCR)

    Measured: 12 weeks

Secondary outcomes (4)

  1. R0 resection rates

    The proportion of patients experiencing a R0 resection

    Measured: 12 weeks

  2. three-year disease-free survival rate, DFS

    Percentage of patients who achieve disease-free survival lasting for more than three years

    Measured: 3 years

  3. three-year Overall survival rate,OS

    Percentage of patients who achieve survival for more than two years

    Measured: 3 years

  4. Incidence of Treatment-Related Adverse Events

    Number of adverse events.

    Measured: 3 years

Timeline

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

  1. First posted16 Aug 2023
  2. Study start9 Mar 2023
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2024 (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
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05994456
Sponsor's protocol ID
HP001
Status last verified
Aug 2023
First submitted
9 Aug 2023
Last updated
16 Aug 2023
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 PD-1 inhibitor in people with Gastric or Gastroesophageal Junction Adenocarcinoma, run by Sun Yat-sen University 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 14 inclusion and 16 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 16 Aug 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?

Results are not available in the source record.

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

Contact Dongsheng Zhang, PhD (86-2087343795, zhangdsh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete remission (pCR) rates (time frame: 12 weeks). 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 NCT05994456.

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 16 Aug 2023.

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