NCT05585580

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P50-P75 for phase_2

Timeline
6mo left

Started Mar 2023

Typical duration for phase_2

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Mar 2023Nov 2026

First Submitted

Initial submission to the registry

September 6, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 19, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Expected
Last Updated

January 7, 2025

Status Verified

September 1, 2024

Enrollment Period

2.7 years

First QC Date

September 6, 2022

Last Update Submit

January 5, 2025

Conditions

Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • Objective response rate （ORR)

    Objective response rate according to RECIST 1.1

    6 months after the last subject participating in

Secondary Outcomes (5)

  • Progression-free survival (PFS)

    24 months after the last subject participating in

  • Overall survival (OS)

    24 months after the last subject participating in

  • Disease Control Rate (DCR)

    6 months after the last subject participating in

  • Duration of Overall Response (DOR)

    6 months after the last subject participating in

  • Safety and tolerability based on incidence of treatment-emergent adverse events as assessed by CTCAE

    through study completion, an average of 1 year.

Study Arms (1)

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.

Drug: SerplulimabDrug: LenvatinibDrug: Paclitaxel/Paclitaxel-albumin/Paclitaxel liposome

Interventions

SerplulimabDRUG

300mg d1 q3w

Serplulimab, lenvatinib and paclitaxel/Paclitaxel for Injection (Albumin Bound)/Paclitaxel liposome
LenvatinibDRUG

8mg po qd

Serplulimab, lenvatinib and paclitaxel/Paclitaxel for Injection (Albumin Bound)/Paclitaxel liposome
Paclitaxel/Paclitaxel-albumin/Paclitaxel liposomeDRUG

135\~175mg/m2 /260mg/m2/135-175mg/m2 d1 q3w

Serplulimab, lenvatinib and paclitaxel/Paclitaxel for Injection (Albumin Bound)/Paclitaxel liposome

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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%;
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Qilu hospital of Shandong univertisy

Jinan, Shandong, 250012, China

RECRUITING

Shandong Provincial Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, 250012, China

RECRUITING

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

Jinan, Shandong, 250012, China

RECRUITING

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China

RECRUITING

Qingdao Municipal Hospital（Group）

Qingdao, Shandong, 266011, China

RECRUITING

Yantai Yuhuangding Hospital

Yantai, Shandong, 264000, China

NOT YET RECRUITING

Linyi Cancer Hospital

Linyi, China

NOT YET RECRUITING

MeSH Terms

Interventions

lenvatinibPaclitaxel

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Lian Liu

    Qilu hospital of Shandong univertisy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lian Liu

CONTACT

0531-82169851tounao@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2022

First Posted

October 19, 2022

Study Start

March 1, 2023

Primary Completion

November 1, 2025

Study Completion (Estimated)

November 1, 2026

Last Updated

January 7, 2025

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(7)