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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Serplulimab, lenvatinib and paclitaxel/Paclitaxel for Injection (Albumin Bound)/Paclitaxel liposome | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serplulimab | Drug | 300mg d1 q3w |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Objective response rate according to RECIST 1.1 | 6 months after the last subject participating in |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | Progression-free survival | 24 months after the last subject participating in |
| Overall survival (OS) | Overall survival |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Lian Liu | Qilu hospital of Shandong univertisy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu hospital of Shandong univertisy | Jinan | Shandong | 250012 | China | ||
| Shandong Provincial Hospital Affiliated to Shandong First Medical University |
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| Lenvatinib | Drug | 8mg po qd |
|
| Paclitaxel/Paclitaxel-albumin/Paclitaxel liposome | Drug | 135~175mg/m2 /260mg/m2/135-175mg/m2 d1 q3w |
|
| 24 months after the last subject participating in |
| Disease Control Rate (DCR) | Disease Control Rate | 6 months after the last subject participating in |
| Duration of Overall Response (DOR) | 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 | Safety and tolerability based on incidence of treatment-emergent adverse events as assessed by CTCAE | through study completion, an average of 1 year. |
| Jinan |
| Shandong |
| 250012 |
| China |
| The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital) | Jinan | Shandong | 250012 | China |
| The Affiliated Hospital of Qingdao University | Qingdao | Shandong | 266000 | China |
| Qingdao Municipal Hospital(Group) | Qingdao | Shandong | 266011 | China |
| Yantai Yuhuangding Hospital | Yantai | Shandong | 264000 | China |
| Linyi Cancer Hospital | Linyi | China |
| ID | Term |
|---|---|
| C531958 | lenvatinib |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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