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

  • STATUS
    Recruiting
  • End date
    Oct 1, 2023
  • participants needed
    18
  • sponsor
    Tianjin Medical University Cancer Institute and Hospital
Updated on 24 March 2022

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.

Details
Condition First-line Treatment, Advanced Gastric Carcinoma
Treatment Lenvatinib
Clinical Study IdentifierNCT05221775
SponsorTianjin Medical University Cancer Institute and Hospital
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

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
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