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Perioperative Chemotherapy Plus Toripalimab for dMMR Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma

ConditionsAdenocarcinoma of the StomachAdenocarcinoma of Esophagogastric JunctionMismatch Repair Deficiency
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorYu jiren

About this trial

This study is a prospective, multi-center, randomized controlled phase II trial to compare the efficacy of perioperative SOX plus toripalimab, toripalimab monotherapy with SOX regimen in participants with dMMR 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.

Mismatch repair deficient (dMMR) adenocarcinoma, which was determined by immunohistochemistry (ICH) test of endoscopic biopsy specimen. dMMR was defined as loss of nuclear expression of one or more MMR proteins.

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

Parallel

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

90 Participants
are divided into 3 treatment groups
Group A: Arm A (Chemotherapy+Toripalimab)Experimental treatment 3 interventions
Group B: Arm B (Toripalimab monotherapy)Experimental treatment 1 intervention
Group C: Arm C (Chemotherapy)Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

Rate of major pathological response (MPR)

Percentage of patients with MPR referring to the total number of patients with surgery, 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) was defined as the time interval from randomization to the last 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
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