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Perioperative Chemotherapy Plus Toripalimab for dMMR Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

Perioperative S-1 Plus Oxaliplatin Combined With Toripalimab or Toripalimab Monotherapy Versus S-1 Plus Oxaliplatin for Treatment of dMMR Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma: a Prospective, Multi-center, Randomized Controlled Study

NCT05729646•Yu jiren

View on ClinicalTrials.gov

Summary

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

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Voluntary participation in the clinical study; fully understands and is informed of the study and has signed the Informed Consent Form (ICF).
•2. Participants were ambulatory male or female. Age: ≥ 18 years and ≤ 80 years old.
•3. Histopathologically confirmed gastric or esophagogastric junction adenocarcinoma.
•4. 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.
•5. 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).
•6. Participants had Eastern Cooperative Oncology Group (ECOG) performance status scores of 0-1 within 7 days before the first dose of study treatment.
•7. Life expectancy ≥ 6 months.
•8. Agreement of providing baseline and surgical specimens for biomarker analysis.
•9. 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#
+12 more criteria

Exclusion Criteria

•1. 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.
•2. Prior systemic therapy for treatment of gastric cancer (surgery, chemotherapy, radiotherapy, targeted therapy or immunotherapy).
•3. 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).
•4. Participants with gastric outlet obstruction, or unable to oral take, or severe gastrointestinal bleeding.
•5. 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).
•6. Existence of chronic diarrhea (watery diarrhea: ≥ 5 times per day).
•7. Participants with active infection within 14 days before the first dose of study treatment which need medical intervention.
•8. Participants with active tuberculosis.
•9. Previous or concurrent diagnosed with interstitial lung disease by imaging or symptoms.
•10. Any of the following test is positive: Human Immunodeficiency Virus (HIV) antibody, Hepatitis B surface Antigen (HBsAg), or Hepatitis C Virus (HCV) antibody.
+7 more criteria

Locations (8)

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

The Second Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Huzhou Central Hospital

Huzhou, Zhejiang, China

Lishui Central Hospital

Lishui, Zhejiang, China

Ningbo First Hospital

Ningbo, Zhejiang, China

Ningbo Medical Center LiHuiLi Hospital

Ningbo, Zhejiang, China

Ningbo Second Hospital

Ningbo, Zhejiang, China

Taizhou Hospital

Taizhou, Zhejiang, China

Key Dates

Start Date

May 31, 2023

Primary Completion Date

February 28, 2026

Completion Date

February 28, 2029

Last Updated

July 25, 2023

Enrollment

ESTIMATED participants

Conditions

Adenocarcinoma of the StomachAdenocarcinoma of Esophagogastric JunctionMismatch Repair Deficiency

Interventions

Toripalimab

DRUG

Oxaliplatin

DRUG

Contacts

Jiren Yu

CONTACT

0086-0571-87237931 yujr0909@zju.edu.cn

Kankai Zhu

CONTACT

zhukankai0401@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 25, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Familial Investigations of Childhood Cancer Predisposition

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