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Safety of XELOX Combined With GLS-010 and Lenvatinib in Advanced AFP-positive Gastric Cancer Patients

Primary Purpose

First-line Treatment, Advanced Gastric Carcinoma

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Lenvatinib
Sponsored by
Tianjin Medical University Cancer Institute and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for First-line Treatment

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female patients ≥ 20 years old;
  2. Patients with advanced / metastatic gastric cancer diagnosed by histopathology, without liver like differentiation, HER-2 negative, AFP ≥ 20ng / ml;
  3. No previous palliative systemic treatment;
  4. There are measurable metastatic lesions according to RECIST version 1.1;
  5. ECOG physical status score is 0 or 1;
  6. Normal organ function: Neutrophil count ≥ 1.2 × 109/L, Platelet count ≥ 100 × 109/L, Hemoglobin (HB) ≥ 80g/L, Total bilirubin ≤ 1.5mg/dl, AST and ALT ≤ 100 IU/L. If the abnormal liver function is due to liver metastasis, AST and ALT should be ≤ 200 IU/L, Creatinine ≤ 1.5 times* upper limit of normal, International standardization ratio (INR) ≤ 1.5
  7. Urinary protein: meet one of the following conditions Urinary protein (test paper method) is 2 + or less, Urinary protein/creatinine (UPC) ratio < 3.5, Determination of 24-hour urinary protein, urinary protein ≤ 3500mg
  8. Before receiving treatment, the patient has recovered the adverse events related to chemotherapy, radiotherapy and surgery to grade 1 or below (CTCAE 5.0);
  9. For women with fertility potential with negative pregnancy test within 14 days before enrollment, male and female patients should agree to use appropriate contraceptive methods from the beginning of the first treatment to 120 days after the last treatment;
  10. Patients who can take oral drugs;
  11. Signed the informed consent.

Exclusion Criteria:

  1. Patients who received surgery and radiotherapy within 2 weeks before enrollment;
  2. Patients who have previously been treated with Lenvatinib or any anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs;
  3. Patients with uncontrollable hypertension (systolic blood pressure ≥ 160mmHg and diastolic blood pressure ≥ 90mmHg);
  4. Patients with acute coronary syndrome (including myocardial infarction and unstable angina) who had undergone coronary angioplasty within 6 months before enrollment;
  5. Patients with symptomatic brain metastases;
  6. Patients with New York Heart Association (NYHA) grade II or above congestive heart failure or severe arrhythmia with severe cardiovascular damage in the past 6 months;
  7. The patients had active malignancies in the past 24 months (except for melanoma in situ, basal cell carcinoma of the skin or squamous cell carcinoma or carcinoma in situ of the cervix)
  8. The patients have severe (hospitalized) complications
  9. Patients with a history of gastrointestinal perforation and/or gastrointestinal fistula within 6 months before enrollment;
  10. Patients with active hepatitis;
  11. Patients with a history of human immunodeficiency virus (HIV) infection;
  12. Patients with symptoms or signs of active interstitial pulmonary disease;
  13. Patients with autoimmune diseases or a history of chronic or recurrent autoimmune diseases;
  14. Patients who need systemic corticosteroids (excluding temporary use for testing, prophylactic administration of allergic reactions or reduction of swelling associated with radiotherapy) or immunosuppressants, or patients who receive such treatment within 14 days before enrollment;
  15. The patient has a history of (non-infectious) pneumonia requiring steroids or has a current history of pneumonia;
  16. Patients who received live vaccine < 30 days before starting trial drug treatment;
  17. The patient has serious non-healing wounds, ulcers or fractures;
  18. Pregnant or lactating women;
  19. The investigator determined that the patient is not suitable to be the subject of this trial;
  20. Other circumstances that the investigator considers inappropriate to participate in the clinical trial.

Sites / Locations

  • Tianjin Medical University Cancer Institute and HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

experimental arm

Arm Description

Outcomes

Primary Outcome Measures

adverse effect
Safety will be evaluated by AE and laboratory tests.

Secondary Outcome Measures

ORR
the rate of patients with PR and CR
PFS
The time from the beginning of treatment to the time when the disease progresses or the patient dies from any cause
OS
The time from the beginning of treatment to the time when the patient dies from any cause

Full Information

First Posted
January 23, 2022
Last Updated
January 23, 2022
Sponsor
Tianjin Medical University Cancer Institute and Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05221775
Brief Title
Safety of XELOX Combined With GLS-010 and Lenvatinib in Advanced AFP-positive Gastric Cancer Patients
Official Title
Safety and Efficacy of XELOX Regimen Combined With GLS-010 and Lenvatinib in Patients With Advanced AFP-positive Gastric Cancer: a Single Center, Prospective, Open Label Phase I Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is a single center, prospective, open label phase I study evaluating the safety and tolerance of standard first-line chemotherapy XELOX regimen combined with GLS-010 (anti-PD-1 antibody) and different doses of Lenvatinib in the treatment of advanced AFP-positive gastric cancer. This study was conducted in the Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Institute and Hospital. In this study, patients with AFP-positive and HER-2-negative advanced gastric cancer who had not received palliative systematic treatment in the past will be enrolled. Patients who met the inclusion criteria were treated with XELOX regimen combined with GLS-010 plus Lenvatinib every 3 weeks until disease progression or intolerable adverse reactions or death. The treatment regimen is XELOX chemotherapy (oxaliplatin 130mg/ m2, d1, capecitabine 850-1250 mg/m2, bid, d1-14, every 3 weeks) in combination with GLS-010 (240 mg, intravenous infusion, every 3 weeks) plus Lenvatinib whose dose is based on the '3 + 3' dose climbing mode (12mg, 16mg and 20mg respectively, orally once a day). Safety will be evaluated by AE and laboratory tests. Patients received regular and periodic reviews, with imaging evaluations every 6 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
First-line Treatment, Advanced Gastric Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Lenvatinib
Intervention Description
XELOX regimen combined with GLS-010 and different doses of Lenvatinib
Primary Outcome Measure Information:
Title
adverse effect
Description
Safety will be evaluated by AE and laboratory tests.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
ORR
Description
the rate of patients with PR and CR
Time Frame
24 months
Title
PFS
Description
The time from the beginning of treatment to the time when the disease progresses or the patient dies from any cause
Time Frame
24 months
Title
OS
Description
The time from the beginning of treatment to the time when the patient dies from any cause
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female patients ≥ 20 years old; Patients with advanced / metastatic gastric cancer diagnosed by histopathology, without liver like differentiation, HER-2 negative, AFP ≥ 20ng / ml; No previous palliative systemic treatment; There are measurable metastatic lesions according to RECIST version 1.1; ECOG physical status score is 0 or 1; Normal organ function: Neutrophil count ≥ 1.2 × 109/L, Platelet count ≥ 100 × 109/L, Hemoglobin (HB) ≥ 80g/L, Total bilirubin ≤ 1.5mg/dl, AST and ALT ≤ 100 IU/L. If the abnormal liver function is due to liver metastasis, AST and ALT should be ≤ 200 IU/L, Creatinine ≤ 1.5 times* upper limit of normal, International standardization ratio (INR) ≤ 1.5 Urinary protein: meet one of the following conditions Urinary protein (test paper method) is 2 + or less, Urinary protein/creatinine (UPC) ratio < 3.5, Determination of 24-hour urinary protein, urinary protein ≤ 3500mg Before receiving treatment, the patient has recovered the adverse events related to chemotherapy, radiotherapy and surgery to grade 1 or below (CTCAE 5.0); For women with fertility potential with negative pregnancy test within 14 days before enrollment, male and female patients should agree to use appropriate contraceptive methods from the beginning of the first treatment to 120 days after the last treatment; Patients who can take oral drugs; Signed the informed consent. Exclusion Criteria: Patients who received surgery and radiotherapy within 2 weeks before enrollment; Patients who have previously been treated with Lenvatinib or any anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs; Patients with uncontrollable hypertension (systolic blood pressure ≥ 160mmHg and diastolic blood pressure ≥ 90mmHg); Patients with acute coronary syndrome (including myocardial infarction and unstable angina) who had undergone coronary angioplasty within 6 months before enrollment; Patients with symptomatic brain metastases; Patients with New York Heart Association (NYHA) grade II or above congestive heart failure or severe arrhythmia with severe cardiovascular damage in the past 6 months; The patients had active malignancies in the past 24 months (except for melanoma in situ, basal cell carcinoma of the skin or squamous cell carcinoma or carcinoma in situ of the cervix) The patients have severe (hospitalized) complications Patients with a history of gastrointestinal perforation and/or gastrointestinal fistula within 6 months before enrollment; Patients with active hepatitis; Patients with a history of human immunodeficiency virus (HIV) infection; Patients with symptoms or signs of active interstitial pulmonary disease; Patients with autoimmune diseases or a history of chronic or recurrent autoimmune diseases; Patients who need systemic corticosteroids (excluding temporary use for testing, prophylactic administration of allergic reactions or reduction of swelling associated with radiotherapy) or immunosuppressants, or patients who receive such treatment within 14 days before enrollment; The patient has a history of (non-infectious) pneumonia requiring steroids or has a current history of pneumonia; Patients who received live vaccine < 30 days before starting trial drug treatment; The patient has serious non-healing wounds, ulcers or fractures; Pregnant or lactating women; The investigator determined that the patient is not suitable to be the subject of this trial; Other circumstances that the investigator considers inappropriate to participate in the clinical trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Ba, MD
Phone
022-23340123
Ext
1053
Email
bayi@tjmuch.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ting Deng, MD
Phone
022-23340123
Ext
1053
Email
xymcdengting@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi Ba, MD
Organizational Affiliation
Tianjin Medical University Cancer Institute and Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Ba, MD
Phone
022-23340123
Ext
1053
Email
bayi@tjmuch.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Safety of XELOX Combined With GLS-010 and Lenvatinib in Advanced AFP-positive Gastric Cancer Patients

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