Trial Title:
Perioperative Chemotherapy Plus Toripalimab for Epstein-Barr Virus-associated Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma
NCT ID:
NCT05970627
Condition:
Adenocarcinoma of the Stomach
Adenocarcinoma of Esophagogastric Junction
Epstein-Barr Virus-Associated Gastric Carcinoma
Conditions: Official terms:
Epstein-Barr Virus Infections
Adenocarcinoma
Stomach Neoplasms
Oxaliplatin
Conditions: Keywords:
Gastric Adenocarcinoma
Esophagogastric Junction Adenocarcinoma
Perioperative Chemotherapy
Toripalimab
Epstein-Barr Virus-associated gastric cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Toripalimab
Description:
Perioperative Toripalimab, 240 mg IV infusion
Arm group label:
Chemotherapy+Toripalimab
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
Oxaliplatin (130 mg/m2) infusion as perioperative chemotherapy
Arm group label:
Chemotherapy+Toripalimab
Intervention type:
Drug
Intervention name:
S1
Description:
S-1 orally intake as perioperative chemotherapy
Arm group label:
Chemotherapy+Toripalimab
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.
Criteria for eligibility:
Criteria:
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. Epstein-Barr Virus-associated Gastric or Esophagogastric Junction Adenocarcinoma,
which was determined by in situ hybridization (ISH) test of endoscopic biopsy
specimen.
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
- 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).
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.
11. 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.
12. Concurrent or previous have severe allergic reaction to any antibody based drugs.
13. Existence of any concurrent autoimmune disease, excepting participants with diabetes
mellitus type I, hypothyroidism requiring only hormone replacement therapy.
14. 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.
15. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem
cell transplantation.
16. Existence of systemic disease that is difficult to control despite treatment with
several agents, for example, diabetes mellitus, hypertension, etc.
17. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital, College of Medicine, Zhejiang University
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Facility:
Name:
The Second Affiliated Hospital, College of Medicine, Zhejiang University
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Contact:
Last name:
Jian Chen
Facility:
Name:
Huzhou Central Hospital
Address:
City:
Huzhou
Zip:
313099
Country:
China
Contact:
Last name:
Yunhai Wei
Facility:
Name:
Lishui Central Hospital
Address:
City:
Lishui
Zip:
323000
Country:
China
Contact:
Last name:
Hongtao Xu
Facility:
Name:
Ningbo First Hospital
Address:
City:
Ningbo
Zip:
315010
Country:
China
Contact:
Last name:
Zhilong Yan
Facility:
Name:
Ningbo Medical Center LiHuiLi Hospital
Address:
City:
Ningbo
Zip:
315048
Country:
China
Contact:
Last name:
Weiming Yu
Facility:
Name:
Ningbo Second Hospital
Address:
City:
Ningbo
Zip:
315099
Country:
China
Contact:
Last name:
Ping Chen
Facility:
Name:
Taizhou Hospital
Address:
City:
Taizhou
Zip:
317099
Country:
China
Contact:
Last name:
Shenkang Zhou
Start date:
July 28, 2023
Completion date:
July 28, 2029
Lead sponsor:
Agency:
Yu jiren
Agency class:
Other
Source:
First Affiliated Hospital of Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05970627
