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This is a single center phase 1 trial to observe safety and efficacy of metronomic capecitabine plus PD-L1 antibody camrelizumab to treat hepatobiliary, pancreatic and other gastrointestinal carcinoma (non-stomach, non-esophagi) patients who had disease progression after all standard regimens.
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.
Hepatobiliary, pancreatic and other gastrointestinal carcinoma (non-stomach, non-esophagi) patients who had disease progression after all 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 |
|---|---|---|
| Rate of 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 | |
|---|---|---|---|---|
| Min Shi, MD & Ph. D | Contact | +86-21-64370045 | sm11998@rjh.com.cn |
| 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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| 48 months |
| Disease control rate | 48 months |
| Duration of response | 48 months |
| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| C000631724 | camrelizumab |
| 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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