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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenvatinib | Drug | XELOX regimen combined with GLS-010 and different doses of Lenvatinib |
|
| Measure | Description | Time Frame |
|---|---|---|
| adverse effect | Safety will be evaluated by AE and laboratory tests. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | the rate of patients with PR and CR | 24 months |
| PFS | The time from the beginning of treatment to the time when the disease progresses or the patient dies from any cause |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Ba, MD | Contact | 022-23340123 | 1053 | bayi@tjmuch.com |
| Ting Deng, MD | Contact | 022-23340123 | 1053 | xymcdengting@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yi Ba, MD | Tianjin Medical University Cancer Institute and Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital | Recruiting | Tianjin | China |
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| ID | Term |
|---|---|
| C531958 | lenvatinib |
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| 24 months |
| OS | The time from the beginning of treatment to the time when the patient dies from any cause | 24 months |