- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05585580
Second-line Treatment With Serplulimab, Lenvatinib, and Paclitaxel in Advanced Gastric Cancer After Prior Immunotherapy
October 17, 2023 updated by: Qilu Hospital of Shandong University
Efficacy and Safety of Serplulimab, Lenvatinib, and Paclitaxel in the Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma After First-line Immunotherapy: a Prospective, Single-armed Clinical Trial
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
59
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lian Liu
- Phone Number: 0531-82169851
- Email: tounao@126.com
Study Locations
-
-
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Linyi, China
- Not yet recruiting
- Linyi Cancer Hospital
-
Contact:
- Li Zhen
-
-
Shandong
-
Jinan, Shandong, China, 250012
- Recruiting
- Qilu Hospital of Shandong Univertisy
-
Contact:
- Lian Liu
- Phone Number: 0531-82169851
- Email: tounao@126.com
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Jinan, Shandong, China, 250012
- Recruiting
- Shandong Provincial Hospital Affiliated to Shandong First Medical University
-
Contact:
- Lei Cong
- Email: wdconglei@163.com
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Jinan, Shandong, China, 250012
- Recruiting
- The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)
-
Contact:
- Jing Liang
- Email: liangjing0531@163.com
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Qingdao, Shandong, China, 266000
- Recruiting
- The Affiliated Hospital of Qingdao University
-
Contact:
- Zimin Liu
- Email: liuzimin301@126.com
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Qingdao, Shandong, China, 266011
- Recruiting
- Qingdao Municipal Hospital(Group)
-
Contact:
- Lu Yue
- Email: lu_yue11@yeah.net
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Yantai, Shandong, China, 264000
- Not yet recruiting
- Yantai Yuhuangding Hospital
-
Contact:
- Aina Liu
- Email: nana4312@sina.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 18-75 years old, gender is not limited;
- Histologically or cytologically proven metastatic or locally advanced gastric or gastroesophageal junction adenocarcinoma
- 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;
- Prior chemotherapy, surgery, radiotherapy, or immunotherapy-related toxicity (excluding alopecia) has resolved to CTCAE ≤ grade 1;
- Has measurable disease as determined by RECIST 1.1;
- 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;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Adequate organ function:
- 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;
- 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);
- 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
- The urine protein of the patient is less than or equal to 1+;
- According to the judgment of the investigator, the life expectancy is ≥6 months;
- Able and willing to give written informed consent and has signed the informed consent form (ICF), prior to performance of any trial activities.
- 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:
- Human epidermal growth factor receptor 2 (HER2) positive;
- History of treatment with multi-target small molecule inhibitors such as lenvatinib or paclitaxel drugs;
- Received systemic therapy (including chemotherapy, immunotherapy or targeted therapy) or local therapy (including surgery, radiotherapy) for advanced disease within 14 days before enrollment;
- Hypertension that is difficult to control by drugs (systolic blood pressure ≥ 160 mmHg and diastolic blood pressure ≥ 90 mmHg);
- 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;
- 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;
- 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));
- Allergy to any study drug or excipients;
- 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;
- 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;
- Long-term heavy use of hormones or use of other immunomodulators;
- Active infection;
- 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;
- Arterial/venous thrombotic events within 6 months, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism;
- 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%;
- History of interstitial lung disease or uncontrolled systemic disease, including diabetes, acute lung disease, etc.;
- Known human immunodeficiency virus (HIV) infection;
- Any major surgery requiring general anesthesia has been performed within ≤ 28 days before the first dose;
- 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;
- Participated in other therapeutic clinical studies.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Serplulimab, lenvatinib and paclitaxel/Paclitaxel for Injection (Albumin Bound)/Paclitaxel liposome
Patients will be treated with serplulimab combined with lenvatinib and paclitaxel/ Paclitaxel for Injection (Albumin Bound)/Paclitaxel liposomefor 6 cycles, followed by serplulimab combined with lenvatinib maintenance therapy until disease progression, intolerable adverse reactions, or withdrawal of treatment consent.
|
300mg d1 q3w
8mg po qd
135~175mg/m2 /260mg/m2/135-175mg/m2 d1 q3w
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate (ORR)
Time Frame: 6 months after the last subject participating in
|
Objective response rate according to RECIST 1.1
|
6 months after the last subject participating in
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival (PFS)
Time Frame: 24 months after the last subject participating in
|
Progression-free survival
|
24 months after the last subject participating in
|
Overall survival (OS)
Time Frame: 24 months after the last subject participating in
|
Overall survival
|
24 months after the last subject participating in
|
Disease Control Rate (DCR)
Time Frame: 6 months after the last subject participating in
|
Disease Control Rate
|
6 months after the last subject participating in
|
Duration of Overall Response (DOR)
Time Frame: 6 months after the last subject participating in
|
Duration of Overall Response
|
6 months after the last subject participating in
|
Safety and tolerability based on incidence of treatment-emergent adverse events as assessed by CTCAE
Time Frame: through study completion, an average of 1 year.
|
Safety and tolerability based on incidence of treatment-emergent adverse events as assessed by CTCAE
|
through study completion, an average of 1 year.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Lian Liu, Qilu Hospital of Shandong Univertisy
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2023
Primary Completion (Estimated)
November 1, 2024
Study Completion (Estimated)
March 1, 2025
Study Registration Dates
First Submitted
September 6, 2022
First Submitted That Met QC Criteria
October 16, 2022
First Posted (Actual)
October 19, 2022
Study Record Updates
Last Update Posted (Actual)
October 19, 2023
Last Update Submitted That Met QC Criteria
October 17, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Adenocarcinoma
- Esophageal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Protein Kinase Inhibitors
- Paclitaxel
- Albumin-Bound Paclitaxel
- Lenvatinib
Other Study ID Numbers
- STILL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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