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

ConditionsAdenocarcinoma of the StomachAdenocarcinoma of Esophagogastric JunctionEpstein-Barr Virus-Associated Gastric Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorYu jiren

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Toripalimab

    Drug

    Perioperative Toripalimab, 240 mg IV infusion

  • Oxaliplatin

    Drug

    Oxaliplatin (130 mg/m2) infusion as perioperative chemotherapy

  • S1

    Drug

    S-1 orally intake as perioperative chemotherapy

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Chemotherapy+ToripalimabExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

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.

Time frame
From enrollment to surgery after pre-operative treatment (up to approximately 36 months)

Secondary outcomes

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

Time frame
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.

Time frame
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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yu jiren

Lead sponsor

First Affiliated Hospital of Zhejiang University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: