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This trial is a prospective, open, randomized, phase II clinical study. It compares the current first-line treatment for advanced gastric cancer in phase II clinical trials, with the best efficacy being the combination of orient-16 study with sintilimab and XELOX regimen. The purpose of this study is to evaluate whether adding anti-angiogenic drugs or chemotherapy drugs on the basis of two-drug chemotherapy regimen (XELOX regimen) and PD-1 monoclonal antibody can improve efficacy for advanced gastric cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XELOX regimen plus sintilimab | Active Comparator | sintilimab 200mg ivgtt d1+oxaliplatin 130mg/m2 ivgtt d1+xeloda 1000mg/m2 bid po d1-14,q3w |
|
| Nab-POF regimen plus sintilimab | Experimental | sintilimab (200mg for the first time, 100mg for the second time, in alteration) ivgtt d1+oxaliplatin 85mg/m2 ivgtt d1+Nab-paclitaxel 125 mg/m2 ivgtt d1+5FU 2.4g/m2 civ48h, q2w |
|
| XELOX regimen plus sintilimab plus lenvatinib | Experimental | sintilimab 200mg ivgtt d1+oxaliplatin 130mg/m2 ivgtt d1+xeloda 1000mg/m2 bid po d1-14+lenvatinib 8mg(<60kg) or 12mg(≥60kg) po qd,q3w |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sintilimab, oxalipaltin, 5FU,Nab-paclitaxel,lenvatinib | Drug | Patients were randomized in a 1:1:1 ratio to three treatment groups: control group A: pembrolizumab combined with XELOX regimen, the regimen was repeated every 3 weeks, and tumor efficacy was evaluated every 2 treatment cycles. Group B: treatment regimen was pembrolizumab combined with Nab-POF regimen, the regimen was repeated every 2 weeks, and tumor efficacy was evaluated every 3 treatment cycles. Group C: treatment regimen was pembrolizumab combined with XELOX regimen and lenvatinib, the regimen was repeated every 3 weeks, and tumor efficacy was evaluated every 2 treatment cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | he proportion of patients whose tumor decrease to a certain size and remained for a certain period of time, including those with complete response (CR) and partial response (PR) | the duration from the date of randomization to any documented tumor progression or death due to any cause,assessed up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | the duration from the date of randomization to the date of death due to any cause,assessed up to 48 months | |
| Progression-free survival time | the duration from the date of randomization to any documented tumor progression or death due to any cause, assessed up to 48 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weijian Guo, Ph.D., M.D. | Contact | +86 021-64175590 | guoweijian1@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Cancer Hospital | Shanghai | Shanghai Municipality | 200032 | China | ||
| Fudan University Shanghai Cancer Center |
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| Disease control rate | assessed based on the RECIST 1.1 criteria, including complete response, partial response, and stable disease | the duration from the date of randomization to any documented tumor progression or death due to any cause, assessed up to 24 months |
| Shanghai |
| Shanghai Municipality |
| 200032 |
| China |
|
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| C000632826 | sintilimab |
| C531958 | lenvatinib |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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