Advanced Gastric or Gastroesophageal Junction AdenocarcinomaPhase 2NCT05585580
Second-line Treatment With Serplulimab, Lenvatinib, and Paclitaxel in Advanced Gastric Cancer After Prior Immunotherapy
A Phase 2 study testing Serplulimab, Lenvatinib and Paclitaxel/Paclitaxel-albumin/Paclitaxel liposome in people with Advanced Gastric or Gastroesophageal Junction Adenocarcinoma, run by Qilu Hospital of Shandong University at 7 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- Serplulimab, Lenvatinib and Paclitaxel/Paclitaxel-albumin/Paclitaxel liposome
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 7 sitesChina
- Study dates
- 1 Mar 2023to 1 Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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；
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- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Qilu hospital of Shandong univertisy
Jinan, Shandong, 250012
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, 250012
The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)
Jinan, Shandong, 250012
Linyi Cancer Hospital
Linyi
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
Qingdao Municipal Hospital（Group）
Qingdao, Shandong, 266011
Yantai Yuhuangding Hospital
Yantai, Shandong, 264000
About this study
Official title: 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.
- Being tested
- Serplulimab, Lenvatinib, Paclitaxel/Paclitaxel-albumin/Paclitaxel liposome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SerplulimabDrug
300mg d1 q3w
LenvatinibDrug
8mg po qd
Paclitaxel/Paclitaxel-albumin/Paclitaxel liposomeDrug
135~175mg/m2 /260mg/m2/135-175mg/m2 d1 q3w
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Serplulimab; Drug: Lenvatinib; Drug: Paclitaxel/Paclitaxel-albumin/Paclitaxel liposome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate （ORR)
Objective response rate according to RECIST 1.1
Measured: 6 months after the last subject participating in
Secondary outcomes (5)
Progression-free survival (PFS)
Progression-free survival
Measured: 24 months after the last subject participating in
Overall survival (OS)
Overall survival
Measured: 24 months after the last subject participating in
Disease Control Rate (DCR)
Disease Control Rate
Measured: 6 months after the last subject participating in
Duration of Overall Response (DOR)
Duration of Overall Response
Measured: 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
Measured: through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start1 Mar 2023
- Primary completion30 Apr 2026
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Gastric or Gastroesophageal Junction AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lian Liu, Principal investigator, Qilu hospital of Shandong univertisy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05585580
- Sponsor's protocol ID
- STILL
- Status last verified
- Apr 2026
- First submitted
- 6 Sep 2022
- Last updated
- 26 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05585580
- Acronym / sponsor ID
- STILL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 19 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Serplulimab, lenvatinib and paclitaxel/Paclitaxel for Injection (Albumin Bound)/Paclitaxel liposome | Experimental | Drug: Serplulimab, Drug: Lenvatinib, Drug: Paclitaxel/Paclitaxel-albumin/Paclitaxel liposomePatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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；
Key exclusion criteria (20 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serplulimab300mg d1 q3w | Drug | Serplulimab, lenvatinib and paclitaxel/Paclitaxel for Injection (Albumin Bound)/Paclitaxel liposome |
| Lenvatinib8mg po qd | Drug | Serplulimab, lenvatinib and paclitaxel/Paclitaxel for Injection (Albumin Bound)/Paclitaxel liposome |
| Paclitaxel/Paclitaxel-albumin/Paclitaxel liposome135~175mg/m2 /260mg/m2/135-175mg/m2 d1 q3w | Drug | Serplulimab, lenvatinib and paclitaxel/Paclitaxel for Injection (Albumin Bound)/Paclitaxel liposome |
Primary outcome
Objective response rate （ORR)
Time frame: 6 months after the last subject participating in
Objective response rate according to RECIST 1.1
5 secondary outcomes
Progression-free survival (PFS)
Time frame: 24 months after the last subject participating in
Overall survival (OS)
Time frame: 24 months after the last subject participating in
Disease Control Rate (DCR)
Time frame: 6 months after the last subject participating in
Duration of Overall Response (DOR)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lian Liu principal investigator
Qilu hospital of Shandong univertisy
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Serplulimab, Lenvatinib and Paclitaxel/Paclitaxel-albumin/Paclitaxel liposome in people with Advanced Gastric or Gastroesophageal Junction Adenocarcinoma, run by Qilu Hospital of Shandong University at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate （ORR) (time frame: 6 months after the last subject participating in). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.