Actively Recruiting
Safety and Efficacy of XELOX Combined With Sintilimab and Lenvatinib in Advanced AFP-positive Gastric Cancer Patients
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2024-04-25
39
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multi-center, prospective, open label phase 2 study evaluating the safety and efficacy of standard first-line chemotherapy XELOX regimen combined with Sintilimab (anti-PD-1 antibody) and 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. Previous phase 1 dose escalation study (TJMUCH-GI-GC002) has demonstrated that such combinational pattern was well tolerated with promising efficacy. 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 Sintilimab 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 Sintilimab (\>=60kg, 200 mg; \<60kg, 3mg/kg; intravenous infusion, every 3 weeks) plus Lenvatinib (determined from previous phase 1 study, 16mg, orally once a day). Patients received regular and periodic reviews, with imaging evaluations every 6 weeks. Safety will be evaluated by AE and laboratory tests.
CONDITIONS
Official Title
Safety and Efficacy of XELOX Combined With Sintilimab and Lenvatinib in Advanced AFP-positive Gastric Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 years or older
- Diagnosed with advanced or metastatic gastric cancer by histopathology, HER-2 negative, AFP ≥ 20 ng/ml
- No previous palliative systemic treatment
- Measurable metastatic lesions according to RECIST version 1.1
- ECOG physical status score of 0 or 1
- Normal organ function including neutrophil count ≥ 1.2 × 10^9/L, platelet count ≥ 100 × 10^9/L, hemoglobin ≥ 80 g/L, total bilirubin ≤ 1.5 mg/dl, AST and ALT ≤ 100 IU/L (≤ 200 IU/L if due to liver metastasis), creatinine ≤ 1.5 times upper limit of normal, INR ≤ 1.5
- Urinary protein test results within specified limits
- Recovery of adverse events related to chemotherapy, radiotherapy, and surgery to grade 1 or below before treatment
- Negative pregnancy test for women with fertility potential within 14 days before enrollment
- Agreement to use appropriate contraception from treatment start to 120 days after last treatment
- Ability to take oral medications
- Signed informed consent
You will not qualify if you...
- Received surgery or radiotherapy within 2 weeks before enrollment
- Previous treatment with Lenvatinib or any anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs
- Uncontrolled hypertension (systolic ≥ 160 mmHg or diastolic ≥ 90 mmHg)
- Acute coronary syndrome or coronary angioplasty within 6 months before enrollment
- Symptomatic brain metastases
- NYHA grade II or above congestive heart failure or severe arrhythmia with severe cardiovascular damage in past 6 months
- Active malignancies within past 24 months except certain skin and cervical cancers
- Severe hospitalized complications
- History of gastrointestinal perforation or fistula within 6 months before enrollment
- Active hepatitis
- History of HIV infection
- Symptoms or signs of active interstitial pulmonary disease
- Autoimmune diseases or history of chronic or recurrent autoimmune diseases
- Need for systemic corticosteroids or immunosuppressants within 14 days before enrollment (except certain temporary uses)
- History or current (non-infectious) pneumonia requiring steroids
- Received live vaccine less than 30 days before starting trial treatment
- Serious non-healing wounds, ulcers, or fractures
- Pregnant or lactating women
- Investigator considers patient unsuitable for the trial
- Other conditions deemed inappropriate by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
Research Team
T
Ting Deng, MD
CONTACT
Y
Yi Ba, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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