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New cocktail aims to tackle stomach cancer when first treatment fails

NCT ID NCT05585580

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a combination of three drugs (serplulimab, lenvatinib, and paclitaxel) in 59 adults with advanced stomach or gastroesophageal junction cancer that progressed after initial immunotherapy. The goal is to see if this mix can shrink tumors and extend life. Participants must have certain markers or have responded well to prior treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 59 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2023

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Linyi Cancer Hospital

    Linyi, China

  • Qilu hospital of Shandong univertisy

    Jinan, Shandong, 250012, China

  • Qingdao Municipal Hospital(Group)

    Qingdao, Shandong, 266011, China

  • Shandong Provincial Hospital Affiliated to Shandong First Medical University

    Jinan, Shandong, 250012, China

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266000, China

  • The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)

    Jinan, Shandong, 250012, China

  • Yantai Yuhuangding Hospital

    Yantai, Shandong, 264000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.