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This is an open-label, multicenter, randomized phase 2 study evaluating the efficacy and safety of fruquintinib plus capecitabine versus capecitabine as maintenance therapy for metastatic colorectal cancer after first-line treatment. Patients who have already achieved disease control (including CR/PR and SD) after ≥6 cycles of standard first-line induction treatment, and are still unresectable would be assigned into 2 maintenance treatment groups by randomization in a 1:1 ratio to receive fruquintinib + capecitabine or capecitabine. All patients will be treated until progressive disease, death from any cause, unacceptable toxicity or informed consent withdrawal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fruquintinib Plus Capecitabine | Experimental | Maintenance therapy with Fruquintinib Plus Capecitabine |
|
| Capecitabine | Active Comparator | Maintenance therapy with Capecitabine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fruquintinib Plus Capecitabine | Drug | Fruquintinib at the dose determined in phase safety lead-in, orally once daily, on d1-21, given every 4 weeks (Q4W). Capecitabine at the dose 850mg/m2, orally twice daily, d1-7 and d15-21, given every 4 weeks (Q4W) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | A duration from the date of initial treatment to disease progression or death of any cause | From Baseline to primary completion date, about 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR, RECIST 1.1) | The incidence of confirmed complete response or partial response | From Baseline to primary completion date, about 24 months |
| Disease Control Rate (DCR, RECIST 1.1) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junjie Peng, MD, PhD | Contact | 86-18017317122 | pengjj67@hotmail.com | |
| Wenhua Li, MD, PhD | Contact | 13817922257 | whliiris@hotmail.com |
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| Capecitabine | Drug | Capecitabine at the dose 850mg/m2, orally twice daily, d1-7 and d15-21, given every 4 weeks (Q4W) |
|
The incidence of complete response, partial response and stable disease
| From Baseline to primary completion date, about 24 months |
| Overall survival (OS) | From the time of enrollment to death caused by any reason | From Baseline to primary completion date, about 24 months |
| The incidence of adverse events | The safety and tolerability of Surufatinib will be evaluated based on adverse events data. | From Baseline to primary completion date, about 24 months |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| C000591844 | HMPL-013 |
| 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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