Trial Title:
A Study of Paclitaxel Combined With Apatinib and Adebrelimab in Gastric/Gastroesophageal Junction Adenocarcinoma
NCT ID:
NCT06415669
Condition:
Gastric/Gastroesophageal Junction Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Esophageal Neoplasms
Paclitaxel
Apatinib
Conditions: Keywords:
paclitaxel
apatinib
adebrelimab
adenocarcinoma of the gastroesophageal junction
gastric carcinoma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Paclitaxel for injection (albumin-bound)
Description:
100 mg/m2, day 1, day 8, every 21 days for a cycle.
Arm group label:
Single arm
Intervention type:
Drug
Intervention name:
Adebrelimab
Description:
20mg/kg or 1200mg, the first day, every 21 days as a cycle.
Arm group label:
Single arm
Other name:
SHR-1316
Intervention type:
Drug
Intervention name:
Apatinib mesylate
Description:
250mg once a day for 5 consecutive days and discontinue for 2 days
Arm group label:
Single arm
Summary:
To evaluate the initial efficacy and safety of paclitaxel for injection (albumin-bound)
in combination with apatinib mesylate and adebrelimab in the treatment of locally
advanced or metastatic gastric/gastroesophageal junction adenocarcinoma following the
progression of previous immunotherapy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
1) Age: 18 ~ 75 years old, male and female;
-
2) ECOG score: 0 or 1;
-
3) Patients with unresectable locally advanced or metastatic gastric
cancer/gastroesophageal junction adenocarcinoma confirmed by histopathology;
-
4) Patients who have received at least first-line immunotherapy progression or
intolerance in the past, and the number of previous systemic treatment lines
does not exceed 2 lines; The best curative effect of frontline containing
PD-1/PD-L1 was CR, PR or SD;
-
5) According to the evaluation criteria for the efficacy of solid tumors (RECIST
1.1), there should be at least one measurable lesion that has not received
local treatment such as radiotherapy (lesions located in the area of previous
radiotherapy can also be selected as target lesions if progression is
confirmed);
-
6) The major organs function normally and meet the following criteria
- a. In the past 14 days without the use of granulocyte colony-stimulating factor, the
absolute value of neutrophil (ANC) ≥1.5x109 /L;
- b. Platelets ≥100×109 /L in the past 14 days without blood transfusion;
- c. Hemoglobin >90g/L in the last 14 days without blood transfusion or use of
erythropoietin;
- d. Total bilirubin ≤1.5× upper limit of normal (ULN);
- e. aspartate aminotransferase (AST), alanine aminotransferase (ALT) in
≤2.5×ULN (ALT or AST ≤5×ULN for patients with liver metastasis);
- f. Serum creatinine ≤1.5×ULN and creatinine clearance (calculated by Cockcroft-Gault
formula) ≥40 ml/min;
- g. Good coagulation function, defined as International standardized ratio (INR) or
prothrombin time (PT) ≤1.5 times ULN;
- h. The myocardial enzyme profile is within the normal range (if the researchers
comprehensively judge that the simple laboratory abnormality is not clinically
significant, it is also allowed to be included);
-
7) Expected survival ≥3 months;
-
8) Women of reproductive age should agree to use contraceptives (such as Iuds,
contraceptives, or condoms) during the study period and for 6 months after the
study ends; Have a negative serum or urine pregnancy test within 7 days prior
to study enrollment and must be a non-lactating patient; Men should consent to
patients who must use contraception during the study period and for 6 months
after the end of the study period;
-
9) Sign informed consent.
Exclusion Criteria:
-
1) Patients who have previously received paclitaxel chemotherapy; Patients with
neoadjuvant or adjuvant treatment with taxoid drugs and disease progression
more than 6 months after the last chemotherapy were excluded;
-
2) HER2-positive patients;
-
3) Patients who are taking immunosuppressants or systemic hormone therapy for
immunosuppressive purposes (dose >10mg/ day prednisone or other therapeutic
hormone) and continue to use within 2 weeks before enrollment;
-
4) Patients with severe liver and kidney insufficiency or heart insufficiency;
-
5) have multiple factors that affect oral drugs (such as inability to swallow,
gastrointestinal resection, chronic diarrhea, and intestinal obstruction);
-
6) Patients with brain metastases accompanied by symptoms or symptom control for
less than 3 months;
-
7) Patients who are known to be allergic to any investigational drug or drug
excipient;
-
8) Pregnant or lactating female patients;
-
9) Patients who underwent major surgical procedures (craniotomy, thoracotomy, or
laparotomy) or had unhealed surgical wounds, ulcers, or fractures within 4
weeks prior to initial dosing, except for patients ≥2 weeks after surgery and
patients with old fractures that the investigator determined could be treated
with the study drug;
-
10) Patients with moderate to severe ascites accompanied by clinical symptoms
requiring repeated drainage; Patients with uncontrolled or clinical symptoms of
pleural effusion or pericardial effusion;
-
11) Patients with clinically significant electrolyte disorders;
-
12) People with acute or chronic active hepatitis B or hepatitis C: hepatitis B
virus (HBV) DNA > 2000IU/ml or 104 copies /ml; Hepatitis C virus (HCV) RNA >
103 copies /ml; Hepatitis B surface antigen (HbsAg) and anti-HCV antibody
positive patients;
-
13) Patients with central nervous system metastasis, but with no clinical symptoms
or accompanied by clinical symptoms after treatment, disease control and stable
time ≥4 weeks can be enrolled; To meet the need for measurable lesions outside
the central nervous system, hormone therapy should be discontinued 14 days
before the first study of medication
-
14) Any life-threatening bleeding event within the previous 3 months, including
patients requiring transfusion therapy, surgery or local therapy, and ongoing
medication;
-
15) Patients with a history of arteriovenous thromboembolism events, including
myocardial infarction, unstable angina pectoris, cerebrovascular accident or
transient ischemic attack, pulmonary embolism, deep vein thrombosis, or any
other severe thromboembolism within the past 6 months. The exception is
implantable intravenous infusion port or catheter-derived thrombosis, or
superficial venous thrombosis, which is stable after conventional anticoagulant
therapy. Allow patients to prophylactically use small doses of low molecular
weight heparin (e.g., enoxaparin 40 mg/ day);
-
16) Uncontrolled hypertension, systolic blood pressure > 160 MMHG or diastolic
blood pressure > 100mmHg after optimal medical treatment, hypertensive crisis
or hypertensive encephalopathy history;
-
17) Symptomatic congestive heart failure (New York Heart Association Grade II-IV).
Symptomatic or poorly controlled arrhythmia. Patients with a history of
congenital long QT syndrome or a QTc > 500ms (calculated using the Fridericia
method) corrected at screening;
-
18) For patients who received radiation therapy more than 4 weeks before the first
treatment, all of the following conditions must be met to be enrolled: there is
no current toxic reaction related to radiation therapy, no need to take
glucocorticoids, and radiation pneumonia, radiation hepatitis, and radiation
enteritis are excluded;
-
19) Patients with previous or current pulmonary diseases such as pulmonary
fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, and
severe impairment of lung function;
-
20) Human immunodeficiency virus (HIV) infection (HIV 1/2 antibody positive), known
syphilis infection;
-
21) Patients with unhealed wounds, fractures, gastric and duodenal ulcers,
persistent positive stool occultiblood, ulcerative colitis, or other conditions
that researchers have determined may cause gastrointestinal bleeding or
perforation;
-
22) All adverse events during the screening period have not returned to baseline or
≤ Grade 1 (NCI-CTCAE V5.0) (except for alopecia, or peripheral sensory
neuropathy, which can be grade 2);
-
23) Patients with severe infections that are active or poorly controlled
clinically. Patients with severe infections in the 4 weeks prior to initial
dosing, including but not limited to hospitalization for complications of
infection, bacteremia, or severe pneumonia;
-
24) Use of immunosuppressive drugs within 4 weeks prior to initial administration,
excluding nasal, inhaled, or other routes of topical corticosteroids or
physiological doses of systemic corticosteroids (i.e., no more than 10mg/ day
of prednisone or equivalent doses of other corticosteroids); To allow temporary
use of glucocorticoids for the treatment of breathing difficulties in diseases
such as asthma and chronic obstructive pulmonary disease;
-
25) Patients who received live attenuated vaccine within 4 weeks prior to initial
administration or who planned to receive live attenuated vaccine during the
study period;
-
26) Patients who received major surgical treatment or significant traumatic injury
4 weeks prior to initial dosing
-
27) Patients who received traditional Chinese medicine with anti-tumor indications
within 2 weeks prior to the first dose;
-
28) Patients with a history of gastrointestinal perforation or abscess within 6
months prior to enrollment;
-
29) Received treatment in other clinical trials within 4 weeks prior to initial
dosing;
-
30) Patients whose urine routine indicated urinary protein ≥2+, or 24-hour urinary
protein quantity >1.0g;
-
31) The presence of any active autoimmune disease or history of autoimmune disease
(e.g., but not limited to: autoimmune hepatitis, interstitial pneumonia,
enteritis, vasculitis, nephritis); Patients with asthma requiring medical
intervention with bronchodilators were not included); However, the following
patients were admitted: vitiligo, psoriasis, alopecia, well-controlled type I
diabetes without systemic therapy, hypothyroidism with normal thyroid function
treated by replacement therapy;
-
32) Other acute or chronic medical conditions, psychiatric disorders, or
abnormalities in laboratory test values that may contribute to these results:
increase the risk associated with study participation or study drug
administration, or interfere with the interpretation of study results, and, in
the investigator's judgment, classify patients as ineligible to participate in
the study;
-
33) Other situations deemed unsuitable for inclusion by the researcher.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Xiamen University
Address:
City:
Fuzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Mingquan Cai
Phone:
13696908231
Email:
mingquan035@163.com
Start date:
May 19, 2024
Completion date:
May 19, 2027
Lead sponsor:
Agency:
The First Affiliated Hospital of Xiamen University
Agency class:
Other
Source:
The First Affiliated Hospital of Xiamen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06415669
