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Trial Title:
Adebrelimab and Fruquintinib Combined With Paclitaxel/Albumin Paclitaxel for Advanced Gastric Cancer After PD-1 Antibody Failed
NCT ID:
NCT06102759
Condition:
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Conditions: Keywords:
gastric cancer
second-line treatment
Adebrelimab
Fruquintinib
chemotherapy
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Adebrelimab，Fruquintinib
Description:
Adebrelimab，Fruquintinib combined with chemotherapy
Arm group label:
Adebrelimab, Fruquintinib combined with paclitaxel
Summary:
This is a prospective, single-center, open, single-arm clinical study to observe and
evaluate the efficacy and safety of Fruquintinib and Adebrelimab combined with
paclitaxel/albumin paclitaxel for second-line treatment of advanced gastric cancer.
Detailed description:
Since the first-line ICIs application of gastric cancer is mainly PD-1 antibody, this
study intends to screen first-line patients exposed to PD-1 antibody and with long
survival (PFS longer than 9 months) to receive second-line PD-L1 antibody for
re-challenge and combine with Fruquintinib and paclitaxel to explore whether it can
further increase the effect of second-line treatment.
Criteria for eligibility:
Study pop:
Advanced gastric cancer that failed first-line treatment with PD1 antibody
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Age ≥18 years old.
2. The ECOG score is 0-1 and does not deteriorate within 7 days.
3. Patients with histologically confirmed, metastatic, or unresectable locally advanced
gastric cancer or GEJ adenocarcinoma.
4. Previously received one systemic chemotherapy regimen for this cancer and
progressed; Or have received adjuvant chemotherapy, but have disease progression or
recurrence within 6 months after the end of treatment.
5. First-line exposure to PD-1 antibodies and first-line treatment of PFS greater than
9 months.
6. Measurable lesions that meet RECIST 1.1 criteria.
7. Have adequate organ and bone marrow function, laboratory tests meet the following
requirements:
1. HGB≥90g/L;
2. NEUT≥1.5×10^9/L;
3. PLT ≥80×10^9/L;
4. TBIL≤1.5 times upper limit of normal value (ULN);
5. ALT and AST≤2.5 x ULN; In liver metastasis, ALT and AST≤5×ULN;
6. Endogenous creatinine clearance ≥50ml/min (Cockcroft-Gault formula);
7. Urinary protein < (++), or 24-hour urinary protein volume < 1.0 g.
8. Normal coagulation function, no active bleeding
1. International standardized ratio INR≤1.5;
2. Partial thromboplastin time APTT≤1.5 ULN.
9. Women of childbearing age must undergo a negative pregnancy test (serum or urine)
within 14 days prior to enrollment and voluntarily use an appropriate method of
contraception during the observation period and within 8 weeks after the last dose
of the study drug; For men, they should be surgically sterilized or consent to an
appropriate method of contraception during the observation period and for 8 weeks
after the last administration of the study drug.
10. Expected survival ≥3 months.
11. Patients voluntarily joined the study and signed an informed consent form (ICF).
12. It is expected that the compliance is good, and the efficacy and adverse reactions
can be followed up according to the protocol requirements.
Exclusion Criteria:
1. Previous treatment with VEGFR inhibitors;
2. Previously received paclitaxel therapy (except for those who received paclitaxel
therapy in neoadjuvant or adjuvant therapy, and the treatment ended more than 6
months after the disease progression);
3. Receive live vaccine within 4 weeks prior to enrollment or possibly during the study
period;
4. Had active autoimmune disease or history of autoimmune disease within 4 weeks prior
to enrollment;
5. Previously received allogeneic bone marrow transplantation or organ transplantation;
6. Hypertension that could not be controlled by drugs before enrollment was defined as:
systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥90 mmHg;
7. Had any disease or condition affecting drug absorption before enrollment, or the
patient could not take drugs orally;
8. Gastrointestinal diseases such as active ulcer of stomach and duodenum, ulcerative
colitis, or active bleeding of unexcised tumors, or other conditions that may cause
gastrointestinal bleeding or perforation as determined by researchers before
enrollment;
9. Patients with evidence or history of significant bleeding tendency within 3 months
prior to enrollment (bleeding within 3 months > 30 mL, hematemesis, stool, stool
blood), hemoptysis, or thromboembolic events (including stroke events and/or
transient ischemic attacks) within 12 months;
10. Clinically significant cardiovascular disease, including but not limited to acute
myocardial infarction, severe/unstable angina pectoris, or coronary artery bypass
grafting within 6 months prior to enrollment; New York Heart Association (NYHA)
Grades for Congestive Heart Failure > Level 2; Ventricular arrhythmias requiring
medical treatment; LVEF (Left ventricular Ejection Fraction) < 50%;
11. Active or uncontrolled severe infection (≥CTCAE v5.0 grade 2 infection);
12. Known human immunodeficiency virus (HIV) infection. Known history of clinically
significant liver disease, including viral hepatitis [Known hepatitis B virus (HBV)
carriers must rule out active HBV infection, i.e., positive HBV DNA (>1×104
copies /mL or > 2000 IU/ mL); known hepatitis C virus infection (HCV) and HCV RNA
positive (>1×103 copies /mL);
13. Any other medical condition, clinically significant metabolic abnormality, physical
abnormality or laboratory abnormality, which, in the investigator's judgment,
reasonably suspects that the patient has a medical condition or condition that is
not suitable for the use of the investigational drug (such as having seizures and
requiring treatment), or which would affect the interpretation of the study results
or place the patient at high risk;
14. The patients considered by the investigators to be unsuitable for inclusion in this
study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Tianjin Medical University Cancer Institute and Hospital
Address:
City:
Tianjin
Zip:
300060
Country:
China
Status:
Recruiting
Contact:
Last name:
Ting Deng, MD
Phone:
022-23340123-1051
Email:
xymcdengting@126.com
Start date:
November 10, 2023
Completion date:
October 10, 2026
Lead sponsor:
Agency:
Tianjin Medical University Cancer Institute and Hospital
Agency class:
Other
Source:
Tianjin Medical University Cancer Institute and Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06102759
