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This is a single center phase 1 trail to observe safety and efficacy of metronomic capecitabine plus PD-L1 antibody camrelizumab as third-line regimen to treat HER2 negative advanced gastric cancer patients.
This study is one of the cohorts of a multi-cohort trial called Combination of Metronomic capecitabine with Camrelizumab for treatment of refractory solid tumor (McCrest) trial.
HER2 negative advanced gastric cancer patients who have disease progression after two standard regimens will be treated by metronomic capecitabine plus camrelizumab. Metronomic capecitabine will be given as fixed dose (500mg bid) orally. Camrelizumab will be given two-weekly (200mg once) intravenously. This regimen will be administered until progression of disease, intolerable toxicity or withdraw of consent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Capecitabine 500mg bid. po. Camrelizumab 200mg ivgtt. d1 q2w |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine, camrelizumab | Drug | This is a single-arm study with all patients receiving these two drugs. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: adverse events as assessed by CTCAE v5.0 | 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | 48 months | |
| Overall survival | 48 months | |
| Objective response rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Liu | Contact | +86-18001753364 | liujing23@vip.163.com | |
| Chenfei Zhou | Contact | +86-13761618390 | raining_grayday@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jun Zhang, MD & Ph. D | Ruijin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oncology, Ruijin Hospital | Recruiting | Shanghai | 200025 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41121239 | Derived | Zhou C, Yin Y, Shangguan C, Wu Q, Cai Q, Xi W, Guo L, Jiang J, Shi M, Wu J, Ji J, Zhang X, Sun Y, Rensen SSM, Damink SWMO, Zhu Z, Zeng R, Zhang J. Lipid metabolism associated with efficacy of metronomic capecitabine and camrelizumab in gastrointestinal cancer: an exploratory clinical trial. BMC Med. 2025 Oct 21;23(1):572. doi: 10.1186/s12916-025-04377-4. |
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| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| C000631724 | camrelizumab |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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| 48 months |
| Disease control rate | 48 months |
| Duration of response | 48 months |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |