Adebrelimab and Fruquintinib Combined With Paclitaxel/Albumin Paclitaxel for Advanced Gastric Cancer

October 22, 2023 updated by: Tianjin Medical University Cancer Institute and Hospital

Phase II Clinical Study of Adebrelimab and Fruquintinib Combined With Paclitaxel/Albumin Paclitaxel for Second-line Treatment of Advanced Gastric Cancer

This is a prospective, single-center, open, single-arm clinical study to observe and evaluate the efficacy and safety of Fruquintinib and Adebrelimab combined with paclitaxel/albumin paclitaxel for second-line treatment of advanced gastric cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The benefits of immunotherapy in first-line treatment for gastric cancer patients whose tumor tissue CPS<5 are limited. And some patients have not been treated by immunotherapy in the first-line treatment in clinical practice. This study intends to enroll first-line patients with advanced gastric cancer who have not been treated with PD-1 antibody, and explore the effectiveness and safety of second-line PD-L1 antibody combined with Fruquintinib and paclitaxel/albumin-paclitaxel, providing clues for the application of PD-L1 antibody in advanced gastric cancer.

Study Type

Observational

Enrollment (Estimated)

30

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

Study Contact Backup

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Recruiting
        • Tianjin Medical University Cancer Institute and Hospital
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Advanced gastric cancer with second-line treatment

Description

Inclusion Criteria:

  1. Age ≥18 years old.
  2. The ECOG score is 0-1 and does not deteriorate within 7 days.
  3. Patients with histologically confirmed, metastatic, or unresectable locally advanced gastric cancer or GEJ adenocarcinoma.
  4. Previously received one systemic chemotherapy regimen for this cancer and progressed; Or have received adjuvant chemotherapy, but have disease progression or recurrence within 6 months after the end of treatment.
  5. There was no PD-1/PD-L1 inhibitor exposure in the first line.
  6. Measurable lesions that meet RECIST 1.1 criteria.

  7. Have adequate organ and bone marrow function, laboratory tests meet the following requirements:

    1. HGB≥90g/L;
    2. NEUT≥1.5×10^9/L;
    3. PLT ≥80×10^9/L;
    4. TBIL≤1.5 times upper limit of normal value (ULN);
    5. ALT and AST≤2.5 x ULN; In liver metastasis, ALT and AST≤5×ULN;
    6. Endogenous creatinine clearance ≥50ml/min (Cockcroft-Gault formula);
    7. Urinary protein < (++), or 24-hour urinary protein volume < 1.0 g.

  8. Normal coagulation function, no active bleeding

    1. International standardized ratio INR≤1.5;
    2. Partial thromboplastin time APTT≤1.5 ULN.
  9. Women of childbearing age must undergo a negative pregnancy test (serum or urine) within 14 days prior to enrollment and voluntarily use an appropriate method of contraception during the observation period and within 8 weeks after the last dose of the study drug; For men, they should be surgically sterilized or consent to an appropriate method of contraception during the observation period and for 8 weeks after the last administration of the study drug.
  10. Expected survival ≥3 months.
  11. Patients voluntarily joined the study and signed an informed consent form (ICF).
  12. It is expected that the compliance is good, and the efficacy and adverse reactions can be followed up according to the protocol requirements.

Exclusion Criteria:

  1. Previous treatment with VEGFR inhibitors;
  2. Previously received paclitaxel therapy (except for those who received paclitaxel therapy in neoadjuvant or adjuvant therapy, and the treatment ended more than 6 months after the disease progression);
  3. Receive live vaccine within 4 weeks prior to enrollment or possibly during the study period;
  4. Had active autoimmune disease or history of autoimmune disease within 4 weeks prior to enrollment;
  5. Previously received allogeneic bone marrow transplantation or organ transplantation;
  6. Hypertension that could not be controlled by drugs before enrollment was defined as: systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥90 mmHg;
  7. Had any disease or condition affecting drug absorption before enrollment, or the patient could not take drugs orally;
  8. Gastrointestinal diseases such as active ulcer of stomach and duodenum, ulcerative colitis, or active bleeding of unexcised tumors, or other conditions that may cause gastrointestinal bleeding or perforation as determined by researchers before enrollment;
  9. Patients with evidence or history of significant bleeding tendency within 3 months prior to enrollment (bleeding within 3 months > 30 mL, hematemesis, stool, stool blood), hemoptysis, or thromboembolic events (including stroke events and/or transient ischemic attacks) within 12 months;
  10. Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina pectoris, or coronary artery bypass grafting within 6 months prior to enrollment; New York Heart Association (NYHA) Grades for Congestive Heart Failure > Level 2; Ventricular arrhythmias requiring medical treatment; LVEF (Left ventricular Ejection Fraction) < 50%;
  11. Active or uncontrolled severe infection (≥CTCAE v5.0 grade 2 infection);
  12. Known human immunodeficiency virus (HIV) infection. Known history of clinically significant liver disease, including viral hepatitis [Known hepatitis B virus (HBV) carriers must rule out active HBV infection, i.e., positive HBV DNA (>1×104 copies /mL or > 2000 IU/ mL); known hepatitis C virus infection (HCV) and HCV RNA positive (>1×103 copies /mL);
  13. Any other medical condition, clinically significant metabolic abnormality, physical abnormality or laboratory abnormality, which, in the investigator's judgment, reasonably suspects that the patient has a medical condition or condition that is not suitable for the use of the investigational drug (such as having seizures and requiring treatment), or which would affect the interpretation of the study results or place the patient at high risk;
  14. The patients considered by the investigators to be unsuitable for inclusion in this study.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adebrelimab, Fruquintinib combined with paclitaxel
Fruquintinib 4mg d1-14, q3w Paclitaxel 150mg/m2, d1, q3w / Albumin paclitaxel 125mg/m2, d1, d8, q3w PD-L1 antibody (Adebrelimab) 20 mg/kg, d1, q3w
Drug: Adebrelimab，Fruquintinib
Adebrelimab，Fruquintinib combined with chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Time from the start of treatment to the progression of the disease
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: From date of randomization until the date of death from any cause or the last visit date, whichever came first, assessed up to 60 months
Time from the start of treatment to the occurrence of death
From date of randomization until the date of death from any cause or the last visit date, whichever came first, assessed up to 60 months
Disease Control rate
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
The proportion of CR,PR and SD
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
The Overall Response Rate
Time Frame: Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
The proportion of CR and PR
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Investigators

  • Principal Investigator: Ting Deng, MD, Tianjin Medical University Cancer Institute and Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

November 10, 2023

Primary Completion (Estimated)

October 10, 2026

Study Completion (Estimated)

October 10, 2026

Study Registration Dates

First Submitted

October 22, 2023

First Submitted That Met QC Criteria

October 22, 2023

First Posted (Actual)

October 26, 2023

Study Record Updates

Last Update Posted (Actual)

October 26, 2023

Last Update Submitted That Met QC Criteria

October 22, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJMUCH-GI-GC05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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