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This is a single center phase 1 trail to observe safety and efficacy of metronomic Capecitabine plus Camrelizumab as second-line regimen to treat head and neck cancer or esophageal squamous 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.
Head and neck cancer / Esophageal squamous cancer patients who have disease progression after first standard regimen 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 | |
|---|---|---|---|---|
| Jing Liu | Contact | +86-18001753364 | liujing23@vip.163.com | |
| Chengfang Shangguan | Contact | +86-13816860375 | sgcf11674@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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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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 |