Trial Title:
The Efficacy and Safety of Benmelstobart for GC/EGC
NCT ID:
NCT06603974
Condition:
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Paclitaxel
Oxaliplatin
Tegafur
Study type:
Interventional
Study phase:
N/A
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:
Procedure
Intervention name:
surgery
Description:
After receiving the corresponding neoadjuvant treatment for 2 cycles, surgery was
performed within 3-6 weeks after drug withdrawal.
Arm group label:
Benmelstobart combined with antiangiogenic drugs and neoadjuvant chemotherapy
Intervention type:
Drug
Intervention name:
Benmelstobart
Description:
1200mg, diluted to 250ml with normal saline, infusion time 60 ± 10mins. The first day of
each cycle, 3 weeks (21 days) as a treatment cycle
Arm group label:
Benmelstobart combined with antiangiogenic drugs and neoadjuvant chemotherapy
Intervention type:
Drug
Intervention name:
tegafur
Description:
it needs to be administered according to the patient's body surface area< 40mg /
time at 1.25m2; > 50mg/ time for 1.25m2 and <1.5m2; > 60mg/ time at 1.5m2; Oral,
twice a day, after morning and evening meals, for 14 consecutive days, rest for 7 days,
as a treatment cycle; Repeat every 3 weeks;
Arm group label:
Benmelstobart combined with antiangiogenic drugs and neoadjuvant chemotherapy
Intervention type:
Drug
Intervention name:
oxaliplatin
Description:
130mg/m2, administered on the first day of each cycle, repeated every 3 weeks;
Arm group label:
Benmelstobart combined with antiangiogenic drugs and neoadjuvant chemotherapy
Intervention type:
Drug
Intervention name:
albumin paclitaxel
Description:
260mg/m2, intravenous infusion, 30 minutes per infusion, once every 3 weeks, administered
on the first and eighth days of each cycle
Arm group label:
Benmelstobart combined with antiangiogenic drugs and neoadjuvant chemotherapy
Summary:
The goal of this clinical trial is to evaluate the major pathological response (MPR) rate
of locally advanced gastric cancer / gastroesophageal junction cancer treated with
bemosumab combined with antiangiogenic drugs and neoadjuvant chemotherapy.
Researchers will use drug Benmelstobart in combination with antiangiogenesis drugs and
newadjuvant chemotherapy to see if the drug works to treat locally advanced gastric
cancer / gastroesophageal junction cancer.
Participants will:injection drug Benmelstobart，On the first day of each cycle, 3 weeks
(21 days) were a treatment cycle.
Detailed description:
The phase i/ii clinical study of benmelstobart combined with anlotinib, oxaliplatin and
capecitabine in the first-line treatment of gastric / gastroesophageal junction
adenocarcinoma has shown good efficacy and safety. Anti vascular drugs have also shown
excellent anti-tumor effects in the neoadjuvant treatment of locally advanced gastric
cancer. Therefore, this study plans to explore the efficacy of benmelstobart combined
with anti angiogenic drugs and neoadjuvant chemotherapy for locally advanced gastric
cancer / gastroesophageal junction cancer, and make up for this part of the treatment
gap.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 1.18 ≤ 70 years old, male or female;
-
2. ECoG score 0-1;
-
3. patients with locally advanced gastric cancer / gastroesophageal junction
cancer confirmed by pathology (histology or cytology) (according to the WHO
classification in 2015);
-
4. according to the eighth edition of clinical tumor TNM staging, patients with
t3~4n+m0 gastric cancer / gastroesophageal junction cancer confirmed to be
resectable or potentially resectable by endoscopic ultrasound and enhanced CT;
-
5. have measurable lesions (according to RECIST 1.1 standard, the long diameter of
CT scan of tumor lesions is ≥ 10mm, and the short diameter of CT scan of lymph
node lesions is ≥ 15mm;), and the tumor is > 2cm directly;
-
6. patients who were initially diagnosed with gastric cancer / gastroesophageal
junction cancer without radiotherapy, chemotherapy, surgery and targeted
therapy before enrollment;
-
7. if the main organ function is normal, it meets the following criteria:
1. Blood routine examination must meet the following requirements (no blood
transfusion, no use of hematopoietic factors and no use of drugs for correction
within 14 days):
1. ANC ≥ 1.5 × 109/l;
2. PLT ≥ 100 × 109/l;
3. HB ≥ 90 g/L；
2. Biochemical tests must meet the following criteria:
1. TBIL ≤ 1.5 × ULN;
2. Alt, AST ≤ 2.5 × ULN
3. Serum creatinine SCR ≤ 1.5 × ULN, endogenous creatinine clearance ≥ 50 ml
/ min (Cockcroft Gault formula);
3. Coagulation function must meet: INR ≤ 1.5 × ULN and APTT ≤ 1.5 × ULN;
-
8. patients with grade I or above myocardial ischemia or myocardial infarction,
arrhythmia (including QTc ≥ 450ms (male), QTc ≥ 470ms (female)) and ≥ grade 2
congestive heart failure (New York Heart Association (NYHA) classification);
-
9. female subjects of childbearing age must have a serum pregnancy test within 3
days before starting the study medication, and the result is negative, and are
willing to use a medically approved high-efficiency contraceptive measure (such
as IUD, contraceptive or condom) during the study period and within 3 months
after the last administration of study medication; For male subjects whose
partner is a female of childbearing age, they should be surgically sterilized,
or agree to use effective methods of contraception during the study and within
3 months after the last study administration; The subjects voluntarily joined
the study and signed the informed consent form. -10.The compliance was good and
they cooperated with the follow-up;
Exclusion Criteria:
-
1. exclusion criteria of target disease
1. Patients with distant metastasis;
2. Subjects who had previously received anti-PD-1 (L1) or CTLA4 mAb therapy;
-
2. medical history and comorbidities
1. Other malignant tumors in the past 3 years;
2. Have any history of active autoimmune disease or autoimmune disease (as
follows, but not limited to: interstitial pneumonia, uveitis, enteritis,
hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism,
hypothyroidism (can be included after hormone replacement therapy)); Patients
with vitiligo or childhood asthma have been completely relieved and can be
included without any intervention in adults; Patients who needed
bronchodilators for medical intervention could not be included;
3. Immunosuppressive drugs used within 14 days before the first use of study
drugs, excluding nasal spray and inhaled corticosteroids or physiological doses
of systemic steroids (i.e. no more than 10 mg/ day prednisone or its
equivalent);
4. Uncontrolled hypertension (systolic blood pressure ≥ 140 mmHg or diastolic
blood pressure ≥ 90 mmHg despite optimal medical treatment);
5. Patients with newly diagnosed angina within 3 months before screening or
myocardial infarction within 6 months before screening; Arrhythmias (including
QTCF: ≥ 450 ms for men and ≥ 470 MS for women) require long-term use of
antiarrhythmic drugs and New York Heart Association class ≥ II cardiac
insufficiency; Or uncontrollable heart failure;
6. There is evidence that there are previous or current pulmonary fibrosis,
interstitial pneumonia, pneumoconiosis, radiologic pneumonia, drug-induced
pneumonia and severe impairment of lung function;
7. Complicated with severe infection within 4 weeks before the first
administration (such as requiring intravenous infusion of antibiotics,
antifungal or antiviral drugs), or fever of unknown cause >38.5 ° C
during the screening period / before the first administration;
8. Clinically significant hemoptysis (more than 50 ml hemoptysis per day) within 3
months before the study, or clinically significant bleeding symptoms or obvious
bleeding tendency (such as gastrointestinal bleeding, gastric ulcer bleeding,
gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood + + or
above the baseline, or suffering from vasculitis, etc.).
9. Known history of allogeneic organ transplantation or allogeneic hematopoietic
stem cell transplantation;
10. Live attenuated vaccine was administered within 4 weeks before the first dose
or planned during the study;
-
3. physical examination and laboratory examination
1. Patients with congenital or acquired immune deficiency, such as human
immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500
iu/ml), hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher
than the detection limit of the analysis method), or combined hepatitis B and C
co infection;
2. Pregnant or lactating women; Patients with fertility are unwilling or unable to
take effective contraceptive measures;
3. Known to have a positive history of human immunodeficiency virus (HIV)
examination or known to have acquired immune deficiency syndrome (AIDS);
-
4. allergy, anaphylaxis and adverse drug reactions
1. Severe allergic reaction to other monoclonal antibodies;
2. Allergy or intolerance to infusion;
3. Have a history of severe allergy to antiangiogenic drugs or their preventive
drugs;
-
5. subjects who are participating in other clinical studies or whose first
medication time is less than 4 weeks from the end of the previous clinical
study (the last medication), or who have 5 half lives of the study drug;
-
6. the subject is known to have a history of psychotropic substance abuse, alcohol
abuse or drug abuse;
-
7. the investigator believes that there are any conditions that may damage the
subject or cause the subject to be unable to meet or perform the research
requirements.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Start date:
October 16, 2024
Completion date:
December 26, 2026
Lead sponsor:
Agency:
Xijing Hospital
Agency class:
Other
Source:
Xijing Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06603974
