Trial Title:
Second-line Treatment With Serplulimab, Lenvatinib, and Paclitaxel in Advanced Gastric Cancer After Prior Immunotherapy
NCT ID:
NCT05585580
Condition:
Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Esophageal Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Lenvatinib
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:
Serplulimab
Description:
300mg d1 q3w
Arm group label:
Serplulimab, lenvatinib and paclitaxel/Paclitaxel for Injection (Albumin Bound)/Paclitaxel liposome
Intervention type:
Drug
Intervention name:
Lenvatinib
Description:
8mg po qd
Arm group label:
Serplulimab, lenvatinib and paclitaxel/Paclitaxel for Injection (Albumin Bound)/Paclitaxel liposome
Intervention type:
Drug
Intervention name:
Paclitaxel/Paclitaxel-albumin/Paclitaxel liposome
Description:
135~175mg/m2 /260mg/m2/135-175mg/m2 d1 q3w
Arm group label:
Serplulimab, lenvatinib and paclitaxel/Paclitaxel for Injection (Albumin Bound)/Paclitaxel liposome
Summary:
This is a prospective, single arm, multicenter phase II study to assess the effectiveness
of Serplulimab, Lenvatinib and Paclitaxel in the treatment of advanced gastric or
gastroesophageal junction adenocarcinoma after first-line immunotherapy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. 18-75 years old, gender is not limited;
2. Histologically or cytologically proven metastatic or locally advanced gastric or
gastroesophageal junction adenocarcinoma
3. Programmed death-ligand 1 (PD-L1) positive subjects (CPS ≥ 1), or those who have
achieved objective response to first-line Programmed death-1 (PD-1)/PD-L1 inhibitor
therapy， or previous first-line PD-1/PD-L1 inhibitor therapy Treatment of PFS ≥ 6
months;
4. Prior chemotherapy, surgery, radiotherapy, or immunotherapy-related toxicity
(excluding alopecia) has resolved to CTCAE ≤ grade 1;
5. Has measurable disease as determined by RECIST 1.1；
6. Subjects who can provide tissue samples (preferably freshly obtained tumor tissue
before second-line therapy) for central laboratory testing for PD-L1 expression
level determination；
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
8. Adequate organ function:
1. Blood routine (no blood transfusion within 14 days before treatment, no
granulocyte colony-stimulating factor, no correction with other drugs) i.
Neutrophil count (NE)>1.5*109/L; ii. Hemoglobin count (HGB) > 90 g/L; iii.
Platelet count (PLT)>100*109/L;
2. Coagulation function (no blood product transfusion within 14 days before
treatment) i. International Normalized Ratio (INR) or Prothrombin Time
(PT)≤1.5*Upper Limit of Normal (ULN);
3. Blood biochemistry (liver and kidney function) i. Creatinine clearance ≥50
mL/min; ii. Total bilirubin (TBIL)≤1.5×ULN; iii. Aspartate aminotransferase
(AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP)≤2.5*ULN;
iv. Albumin > 2.7 g/dL
9. The urine protein of the patient is less than or equal to 1+;
10. According to the judgment of the investigator, the life expectancy is ≥6 months;
11. Able and willing to give written informed consent and has signed the informed
consent form (ICF), prior to performance of any trial activities.
12. Female patients must be surgically sterilized females, postmenopausal, or using some
form of highly effective contraception during treatment and within 12 weeks after
treatment; male patients must be surgically sterilized men, or during treatment and
6 months after treatment effective contraceptive method
Exclusion Criteria:
1. Human epidermal growth factor receptor 2 (HER2) positive;
2. History of treatment with multi-target small molecule inhibitors such as lenvatinib
or paclitaxel drugs;
3. Received systemic therapy (including chemotherapy, immunotherapy or targeted
therapy) or local therapy (including surgery, radiotherapy) for advanced disease
within 14 days before enrollment;
4. Hypertension that is difficult to control by drugs (systolic blood pressure ≥ 160
mmHg and diastolic blood pressure ≥ 90 mmHg);
5. Patients with brain metastases, cancerous meningitis, spinal cord compression, or
diseases of the brain or leptomeninges found in imaging CT or MRI examinations
during screening;
6. Associated with refractory pleural effusion or ascites, such as pleural effusion or
ascites that requires puncture and drainage within 2 weeks before the first
administration;
7. Have other malignancies except cured cervical carcinoma in situ, non-melanoma skin
cancer, and superficial bladder tumors (Ta (non-invasive tumor), Tis (carcinoma in
situ), and T1 (tumor invading basement membrane));
8. Allergy to any study drug or excipients;
9. Chronic hepatitis B or HBV carriers with chronic hepatitis B virus (HBV) DNA
exceeding 500 IU/mL, or patients with active hepatitis C virus (HCV) infection;
10. Presence of any active autoimmune disease or history of autoimmune disease
(including but not limited to: autoimmune hepatitis, interstitial pneumonia,
uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, thyroid function
Hyperthyroidism, hypothyroidism), or a known history of allogeneic organ
transplantation or allogeneic hematopoietic stem cell transplantation, or other
investigators' assessment that they have an impact on the study treatment;
11. Long-term heavy use of hormones or use of other immunomodulators;
12. Active infection;
13. Have been vaccinated with live or attenuated vaccines within 30 days before the
first dose, or plan to receive live or attenuated vaccines during the study period,
excluding the new crown vaccine;
14. Arterial/venous thrombotic events within 6 months, such as cerebrovascular accident,
deep vein thrombosis and pulmonary embolism;
15. Severe cardiovascular disease: myocardial ischemia or myocardial infarction above
grade II, or stent placement within 6 months before enrollment; poorly controlled
arrhythmia; according to the New York Heart Association (NYHA) criteria, III to IV
Grade 1 cardiac insufficiency, or echocardiography showed left ventricular ejection
fraction (LVEF) <50%;
16. History of interstitial lung disease or uncontrolled systemic disease, including
diabetes, acute lung disease, etc.;
17. Known human immunodeficiency virus (HIV) infection;
18. Any major surgery requiring general anesthesia has been performed within ≤ 28 days
before the first dose;
19. There is an underlying medical condition or alcohol/drug abuse or dependence that is
not conducive to the administration of the study drug, or may affect the
interpretation of the results, or put the patient at a high risk of treatment
complications;
20. Participated in other therapeutic clinical studies.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Qilu hospital of Shandong univertisy
Address:
City:
Jinan
Zip:
250012
Country:
China
Status:
Recruiting
Contact:
Last name:
Lian Liu
Phone:
0531-82169851
Email:
tounao@126.com
Facility:
Name:
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Address:
City:
Jinan
Zip:
250012
Country:
China
Status:
Recruiting
Contact:
Last name:
Lei Cong
Email:
wdconglei@163.com
Facility:
Name:
The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)
Address:
City:
Jinan
Zip:
250012
Country:
China
Status:
Recruiting
Contact:
Last name:
Jing Liang
Email:
liangjing0531@163.com
Facility:
Name:
The Affiliated Hospital of Qingdao University
Address:
City:
Qingdao
Zip:
266000
Country:
China
Status:
Recruiting
Contact:
Last name:
Zimin Liu
Email:
liuzimin301@126.com
Facility:
Name:
Qingdao Municipal Hospital（Group）
Address:
City:
Qingdao
Zip:
266011
Country:
China
Status:
Recruiting
Contact:
Last name:
Lu Yue
Email:
lu_yue11@yeah.net
Facility:
Name:
Yantai Yuhuangding Hospital
Address:
City:
Yantai
Zip:
264000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Aina Liu
Email:
nana4312@sina.com
Facility:
Name:
Linyi Cancer Hospital
Address:
City:
Linyi
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Li Zhen
Start date:
March 1, 2023
Completion date:
March 1, 2025
Lead sponsor:
Agency:
Qilu Hospital of Shandong University
Agency class:
Other
Source:
Qilu Hospital of Shandong University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05585580
