| Eligibility |
Inclusion Criteria:
1. age: 18 years and older, male or female.
2. patients with pathologically or cytologically confirmed gastric cancer (GC) or
gastroesophageal junction cancer (GEJ).
3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
4. measurable lesions that meet RECIST1.1 criteria.
5. Patients with gastric cancer who have progressed on first-line immunotherapy have
achieved CR or PR or SD = 3 months on the first immunotherapy;
6. expected survival = 3 months;
7. Normal function of major organs, no severe blood, heart, lung, liver and kidney
dysfunction and immunodeficiency diseases. Laboratory tests were to meet the following
requirements: neutrophil count (ANC) = 1,500/mm3 (1.5 × 109/L) (no growth factors used
within 14 days); platelet count (PLT) = 100,000/mm3 (100 × 109/L) (no corrective
treatment used within 7 days); hemoglobin (Hb) = 9 g/dL (90 g/L) (no corrective
treatment used within 7 days); serum creatinine = 1.5 times the upper limit of normal
(ULN) or creatinine clearance = 60 mL/min; total bilirubin (BIL) = 1.5 times the upper
limit of normal (ULN); aspartate aminotransferase (AST/SGOT) or alanine
aminotransferase (ALT/SGPT) levels = 2.5 times the upper limit of normal (ULN), and =
5 × ULN for patients with liver metastases. Serum Cr = 1.5 times ULN, endogenous
creatinine clearance > 50ml/min (Cockcroft-Gault formula); Normal urine routine, or
urine protein < (+ +), or 24-hour urine protein < 1.0g;
8. normal coagulation function, no active bleeding and thrombosis disease: international
normalized ratio INR = 1.5 × ULN; partial thromboplastin time APTT = 1.5 × ULN;
prothrombin time PT = 1.5ULN;
9. Patients with potential fertility need to use a medically recognized contraceptive
(such as intrauterine device, contraceptives or condoms) during study treatment and
within 3 months after the end of study treatment; and must have a negative serum HCG
test within 72 hours before study enrollment; and must be non-lactating. I agree and
have signed an informed consent form and am willing and able to comply with scheduled
visits, study treatment plan, laboratory tests, and other trial procedures.
Exclusion Criteria:
1. history of gastrointestinal perforation and/or fistula within 6 months before the
first dose;
2. presence of uncontrollable pleural effusion, pericardial effusion, or abdominal
effusion requiring repeated drainage;
3. previous history of hypersensitivity to monoclonal antibodies, any component of
adalimumab, and nab-paclitaxel;
4. received any of the following treatments: a. previously received immunotherapy with
serious adverse reactions; b. received any investigational drug within 4 weeks before
the first use of study drug; c. enrolled in another clinical study at the same time,
unless it was an observational (non-interventional) clinical study or interventional
clinical study follow-up; d. received the last dose of anticancer therapy = 3 weeks
before the first use of study drug and received fixed-field palliative radiotherapy =
2 weeks before the first study intervention treatment; e. subjects who required
corticosteroids (> 10 mg prednisone equivalent dose per day) within 2 weeks before the
first use of study drug. Other special situations require communication with the
sponsor. In the absence of active autoimmune disease, inhaled or topical steroids and
adrenocorticotropic hormone replacement at doses > 10 mg/day prednisone efficacy dose
are allowed; f. those who have received anti-tumor vaccines or live vaccines within 4
weeks before the first dose of study drug; g. major surgery or severe trauma within 4
weeks before the first dose of study drug;
5. previous anti-tumor treatment toxicity did not recover to = CTCAE grade 1 (except
alopecia) or the level specified in the inclusion/exclusion criteria;
6. patients with central nervous system metastases;
7. History of active autoimmune diseases, autoimmune diseases (such as interstitial
pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism,
hypothyroidism, including but not limited to these diseases or syndromes): except
leukoplakia or recovered childhood asthma/allergy, patients who do not require any
intervention after adulthood: autoimmune-mediated hypothyroidism treated with stable
doses of thyroid replacement hormone; type I diabetes treated with stable doses of
membrane insulin;
8. history of immunodeficiency, including HIV test positive, or suffering from other
acquired, congenital immunodeficiency diseases, or history of organ transplantation
and allogeneic bone marrow transplantation;
9. the subject has cardiovascular clinical symptoms or diseases that are not well
controlled, including but not limited to: (1) heart failure above NYHA II; (2)
unstable angina pectoris; (3) myocardial infarction within 1 year; (4) clinically
significant supraventricular or ventricular arrhythmia that remains poorly controlled
without or after clinical intervention;
10. Urine routine showed urine protein = + + and confirmed 24-hour urine protein > 1.0g;
11. Patients with abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN
+ 4 seconds), bleeding tendency or receiving thrombolytic or anticoagulant therapy are
allowed to receive low-dose low-molecular-weight heparin or oral aspirin to prevent
anticoagulant therapy during the trial;
12. Patients who have experienced clinically significant bleeding symptoms or definite
bleeding tendency within 3 months before randomization, such as gastrointestinal
bleeding, hemorrhagic gastric ulcer or suffering from vasculitis, etc. If fecal occult
blood is positive at baseline, they can be reexamined. If it is still positive after
reexamination, gastroscopy should be performed when necessary in combination with
clinical judgment;
13. Accompanied by active ulcers, unhealed wounds or fractures;
14. Patients with hypertension, and can not be well controlled by antihypertensive drug
treatment (systolic blood pressure = 140 mmHg or diastolic blood pressure = 90 mmHg);
15. serious infection (CTCAE > 2) within 4 weeks before the first use of the study drug,
such as severe pneumonia requiring hospitalization, bacteremia, infectious
complications, etc.; baseline chest imaging showed active pulmonary inflammation,
symptoms and signs of infection within 2 weeks before the first use of the study drug
or the need for oral or intravenous antibiotic treatment, except for the prophylactic
use of antibiotics;
16. Patients with a history of interstitial lung disease (except radiation pneumonitis and
non-infectious pneumonitis who have not used hormone therapy);
17. Patients with active pulmonary tuberculosis infection found by medical history or CT
examination, or patients with a history of active pulmonary tuberculosis infection
within 1 year before enrollment, or patients with a history of active pulmonary
tuberculosis infection more than 1 year ago but without regular treatment;
18. Patients who have been diagnosed with any other malignant tumor within 5 years before
the first use of the study drug, except for malignant tumors with low risk of
metastasis and death (5-year survival rate > 90%), such as adequately treated basal
cell or squamous cell skin cancer or cervical carcinoma in situ;
19. Pregnant or lactating women;
20. The investigator judges that the subject has other factors that may cause the subject
to be forced to terminate the study halfway, such as having other serious diseases
(including mental illness) requiring concomitant treatment, severely abnormal
laboratory values, family or social factors, which may affect the subject 's safety or
the collection of trial data.
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