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Adenocarcinoma of the StomachPhase 2NCT05970627

Perioperative Chemotherapy Plus Toripalimab for Epstein-Barr Virus-associated Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma

A Phase 2 study testing Toripalimab, Oxaliplatin and S1 in people with Adenocarcinoma of the Stomach and Adenocarcinoma of Esophagogastric Junction, run by Yu jiren at 8 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This study is a prospective, single arm, multi-center phase II clinical trial designed to evaluate the efficacy and safety of perioperative SOX combined with toripalimab in participants with Epstein-Barr Virus-associated locally advanced gastric or esophagogastric junction adenocarcinoma. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Toripalimab, Oxaliplatin and S1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
8 sitesChina
Study dates
28 Jul 2023to 28 Jul 2029
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntary participation in the clinical study; fully understands and is informed of the study and has signed the Informed Consent Form (ICF).
  • Participants were ambulatory male or female. Age: ≥ 18 years and ≤ 80 years old.
  • Histopathologically confirmed gastric or esophagogastric junction adenocarcinoma.
  • Epstein-Barr Virus-associated Gastric or Esophagogastric Junction Adenocarcinoma, which was determined by in situ hybridization (ISH) test of endoscopic biopsy specimen.
  • cT2-4bN+/-, M0 according to the American Joint Committee on Cancer and Union for International Cancer Control (AJCC-UICC) TNM classification for carcinoma of the stomach (8th edition).
  • Participants had Eastern Cooperative Oncology Group (ECOG) performance status scores of 0-1 within 7 days before the first dose of study treatment.
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  • Life expectancy ≥ 6 months.
  • Agreement of providing baseline and surgical specimens for biomarker analysis.
  • The functions of the vital organs meet requirements as follows (within 14 days before the first dose of study treatment, meanwhile, participants had not received treatment of recombinant human thrombopoietin or granulocyte stimulating factor):
  • 1). Hematological function
  • White blood cell count (WBC): 3.5 × 10^9/L ~12.0 × 10^9/L
  • Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L
  • Platelet count (PLT) ≥ 100 × 10^9/L
  • Hemoglobin (Hb) ≥ 90g/L. 2). Hepatic function
  • Total bilirubin (TBIL) ≤ 1.5 × ULN (upper limit of normal); -Aspartate aminotransferase (AST) ≤ 2.5 × ULN;
  • Alanine aminotransferase (ALT) ≤ 2.5 × ULN;
  • Albumin (ALB) ≥ 30g/L. 3). Renal function
  • Creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance ≥ 60 ml/min for those with creatinine level > 1.5 × ULN.
  • 4). Coagulation function
  • International normalized ratio (INR) ≤ 1.5;
  • Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
  • 10. Female participants of childbearing age must meet requirements: urine or serum pregnancy test must be negative within 7 days before the first dose of study treatment, and she must agree to use adequate contraception methods or keep abstinence (starting with the ICF is signed through 120 days after the last dose of toripalimab, or 180 days after the last dose of chemotherapy, whichever is longer, and should not be breastfeeding. Male participants must meet requirements: agree to use adequate contraception methods or keep abstinence (starting with the ICF is signed through 120 days after the last dose of toripalimab, or 180 days after the last dose of chemotherapy, whichever is longer).

Who cannot join

  • HER2-positive status defined as either IHC score of 3+ or IHC 2+ with amplification proven by fluorescent in situ hybridization (FISH) based on pretreatment endoscopic biopsies.
  • Prior systemic therapy for treatment of gastric cancer (surgery, chemotherapy, radiotherapy, targeted therapy or immunotherapy).
  • Previous or concurrent have other active malignant tumors within the past 5 years (except for basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate cancer or cervical cancer or breast cancer in situ that has undergone curative therapy).
  • Participants with gastric outlet obstruction, or unable to oral take, or severe gastrointestinal bleeding.
  • Myocardial infarction within 6 months before the first dose of study treatment, uncontrolled angina, arrhythmia which need medical intervention (including but not limited to cardiac pacemaker), congestive heart failure (New York Heart Association (NYHA) class III or IV).
  • Existence of chronic diarrhea (watery diarrhea: ≥ 5 times per day).
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  • Participants with active infection within 14 days before the first dose of study treatment which need medical intervention.
  • Participants with active tuberculosis.
  • Previous or concurrent diagnosed with interstitial lung disease by imaging or symptoms.
  • Any of the following test is positive: Human Immunodeficiency Virus (HIV) antibody, Hepatitis B surface Antigen (HBsAg), or Hepatitis C Virus (HCV) antibody.
  • Participants who need long-term systemic steroid therapy (> 10 mg/d prednisone equivalent) or any other form of immunosuppressive therapy within 14 days before the first dose of study treatment or during the study period.
  • Concurrent or previous have severe allergic reaction to any antibody based drugs.
  • Existence of any concurrent autoimmune disease, excepting participants with diabetes mellitus type I, hypothyroidism requiring only hormone replacement therapy.
  • Receive live vaccines within 28 days before the first dose of study treatment or during the study period, excepting inactivated viral vaccines for seasonal influenza.
  • Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
  • Existence of systemic disease that is difficult to control despite treatment with several agents, for example, diabetes mellitus, hypertension, etc.
  • Existence of other serious physical or mental diseases or serious laboratory abnormalities that may increase the risk of participating in the study. Participants who were judged unsuitable as subjects of this trial by investigator.

Trial locations and contacts

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

Jiren Yu contact

0086-0571-87237931

yujr0909@zju.edu.cn

Kankai Zhu contact

zhukankai0401@163.com

8 sites in 1 country

China8 sites

  • The First Affiliated Hospital, College of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310003

  • The Second Affiliated Hospital, College of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310003

    Jian Chen

  • Huzhou Central Hospital

    Huzhou, Zhejiang, 313099

    Yunhai Wei

  • Lishui Central Hospital

    Lishui, Zhejiang, 323000

    Hongtao Xu

  • Ningbo First Hospital

    Ningbo, Zhejiang, 315010

    Zhilong Yan

  • Ningbo Medical Center LiHuiLi Hospital

    Ningbo, Zhejiang, 315048

    Weiming Yu

  • Ningbo Second Hospital

    Ningbo, Zhejiang, 315099

    Ping Chen

  • Taizhou Hospital

    Taizhou, Zhejiang, 317099

    Shenkang Zhou

Other trials in China

About this study

Official title: Perioperative Chemotherapy Combined With PD-1 Inhibitor (Toripalimab) for Treatment of Epstein-Barr Virus-associated Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma: a Prospective, Multi-center, Phase II Study

This study is a prospective, single arm, multi-center phase II clinical trial designed to evaluate the efficacy and safety of perioperative SOX combined with toripalimab in participants with Epstein-Barr Virus-associated locally advanced gastric or esophagogastric junction adenocarcinoma.

Being tested
Toripalimab, Oxaliplatin, S1
Keywords
Gastric Adenocarcinoma, Esophagogastric Junction Adenocarcinoma, Perioperative Chemotherapy, Toripalimab, Epstein-Barr Virus-associated gastric cancer

What participants receive

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

  • ToripalimabDrug

    Perioperative Toripalimab, 240 mg IV infusion

  • OxaliplatinDrug

    Oxaliplatin (130 mg/m2) infusion as perioperative chemotherapy

  • S1Drug

    S-1 orally intake as perioperative chemotherapy

Study groups in NCT05970627
Study groupRoleWhat they receive
Chemotherapy+ToripalimabExperimentalToripalimab: 240 mg IV infusion on Day 1 of each 21 day cycle for 3 cycles prior to surgery and 3 cycles after surgery. Chemotherapy: SOX(S-1+Oxaliplatin) Oxaliplatin,administered as a 2-hour intravenous infusion (130mg/m2) S-1, orally twice daily for 2 weeks followed by a 7-day rest period. The dose of S-1 was 80 mg/day for body surface area less than 1.25 m2, 100 mg/day for body surface area greater than or equal to 1.25 to less than 1.5 m2, and 120 mg/day for body surface area greater than or equal to 1.5 m2 Chemotherapy will be repeated each 21 day for 3 cycles prior to surgery and 3 cycles after surgery.
Receives: Drug: Toripalimab; Drug: Oxaliplatin; Drug: S1

What is being measured

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

  1. Rate of pathological complete responses (pCR)

    Percentage of patients with pCR referring to the total number of enrolled and eligible patients, as evaluated centrally by a reference pathologist.

    Measured: From enrollment to surgery after pre-operative treatment (up to approximately 36 months)

Secondary outcomes (3)

  1. Overall survival

    The duration of overall survival (OS) will be determined by measuring the time interval from enrollment to the end of follow up or death from any cause

    Measured: From randomization to the last follow-up or death from any cause (up to approximately 72 months)

  2. Progression-free survival

    Progression-free survival (PFS) was defined as the time from randomization to the last follow-up or the time of disease progression or relapse or death from any cause.

    Measured: From randomization to the last follow-up or the time of disease progression or relapse or death from any cause (up to approximately 72 months)

  3. The incidences and types of adverse events (AE) and severe adverse events (SAE)

    The incidences and severity of adverse events that occur during treatment will be evaluated according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.3

    Measured: From enrollment to 90-day after the last dose administration (up to approximately 39 months)

Timeline

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

  1. First posted1 Aug 2023
  2. Study start28 Jul 2023 (estimated)
  3. Primary completion28 Jul 2026 (estimated)
  4. Study completion28 Jul 2029 (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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05970627
Sponsor's protocol ID
IIT20230033C-R1
Status last verified
Jul 2023
First submitted
25 Jul 2023
Last updated
1 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 Toripalimab, Oxaliplatin and S1 in people with Adenocarcinoma of the Stomach and Adenocarcinoma of Esophagogastric Junction, run by Yu jiren at 8 sites 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 22 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: opening soon, as of the sponsor's last update on 1 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 8 sites 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 Jiren Yu (0086-0571-87237931, yujr0909@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of pathological complete responses (pCR) (time frame: From enrollment to surgery after pre-operative treatment (up to approximately 36 months)). 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 NCT05970627.

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 1 Aug 2023.

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