Trial Title:
Perioperative Chemotherapy Combined With Serplulimab or Placebo for pMMR Locally Advanced Gastric Adenocarcinoma (FOCUS-05)
NCT ID:
NCT05872685
Condition:
Adenocarcinoma of the Stomach
Adenocarcinoma of Esophagogastric Junction
Proficient Mismatch Repair
Conditions: Official terms:
Adenocarcinoma
Oxaliplatin
Conditions: Keywords:
Gastric Adenocarcinoma
Perioperative Chemotherapy
Serplulimab
Proficient mismatch repair
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
S1
Description:
S-1 orally intake as perioperative chemotherapy
Arm group label:
Group A (Chemotherapy+Serplulimab )
Arm group label:
Group B (Chemotherapy+Placebo )
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
Oxaliplatin (130 mg/m2) infusion as perioperative chemotherapy
Arm group label:
Group A (Chemotherapy+Serplulimab )
Arm group label:
Group B (Chemotherapy+Placebo )
Intervention type:
Drug
Intervention name:
Serplulimab
Description:
Perioperative serplulimab, 300 mg IV infusion
Arm group label:
Group A (Chemotherapy+Serplulimab )
Intervention type:
Drug
Intervention name:
Placebo
Description:
Perioperative placebo, 300 mg IV infusion
Arm group label:
Group B (Chemotherapy+Placebo )
Summary:
This phase II study is a prospective, multi-center, double-blinded, and randomized trial
to compare the efficacy and safety of perioperative SOX plus serplulimab with SOX plus
placebo for locally advanced gastric adenocarcinoma with proficient mismatch repair
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. The gender is not limited. Age: ≥ 18 years and ≤ 80 years old.
3. Gastric or esophagogastric junction adenocarcinoma confirmed by pathology, and
proficient mismatch repair confirmed by immunohistochemistry.
4. Clinical stage at presentation: cT2-T4b, N+/-, M0 as determined by AJCC staging
system, 8th edition.The definition of metastatic lymph nodes: a lymph node must be ≥
10mm in short axis when assessed by CT scan (CT scan slice thickness recommended to
be no greater than 5 mm) according to the guideline of Response Evaluation Criteria
in Solid Tumours (RECIST version 1.1)
5. Participants with a performance status of 0 ~ 1 on the Eastern Cooperative Oncology
Group (ECOG) within 7 days before the first dose of study treatment.
6. Life expectancy ≥ 6 months.
7. Agreement of providing pretreatment endoscopic biopsies specimens and surgical
specimens for biomarker analysis, as well as the peripheral blood, feces and urine
sample.
8. The functions of the vital organs meet requirements as follow (within 14 days before
the first dose of study treatment, participant has not received treatment of
recombinant human thrombopoietin or granulocyte stimulating factor):
8.1 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) ≥ 90 g / L.
8.2 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) ≥ 30 g / L.
8.3 Renal function： Creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance ≥ 60 ml /
min for those with creatinine level > 1.5 × ULN.
8.4 Coagulation function： International normalized ratio (INR) ≤ 1.5; Prothrombin
time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
9. Female 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 serplulimab, or 180 days
after the last dose of chemotherapy, whichever is longer, and should not be
breastfeeding.
10. For the 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 serplulimab, or 180 days after the last dose of
chemotherapy, whichever is longer).
Exclusion Criteria:
1. HER2-positive, EBER-positive or dMMR.
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 for 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
Status:
Recruiting
Contact:
Last name:
Jiren Yu
Facility:
Name:
The Second Affiliated Hospital, College of Medicine, Zhejiang University
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jian Chen
Facility:
Name:
Lishui Central Hospital
Address:
City:
Lishui
Zip:
323000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Hongtao Xu
Facility:
Name:
Ningbo Medical Center LiHuiLi Hospital
Address:
City:
Ningbo
Zip:
315048
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Weiming Yu
Facility:
Name:
Taizhou Hospital
Address:
City:
Taizhou
Zip:
317099
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Shenkang Zhou
Start date:
December 24, 2023
Completion date:
April 30, 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/NCT05872685
