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This is an open-label, single center, non-randomized, phase â…¡ trial to evaluate safety and efficacy of using the combination treatment of Camrelizumab with anti-angiogenic drugs and Chemotherapy of metastatic colorectal mucinous adenocarcinoma(MAC).
Colorectal cancer contains multiple pathological types, and one of the more special pathological types is mucinous adenocarcinoma. The prognosis of patients with mucinous adenocarcinoma is not ideal.Some molecular and genetic factors may be related to the characteristics of mucinous adenocarcinoma, in which microsatellite instability and loss of mismatch repair proteins are a focus of current research. Microsatellite instability is often associated with poor differentiation and higher tumor stage. Adenocarcinoma that secretes a large amount of mucus in pathological features.so,In this study, the incidence of ORR and AEs was the main endpoint, and the efficacy and safety of Camrelizumab combined with anti-angiogenic drugs in the treatment of advanced colorectal mucinous adenocarcinoma were observed and evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Two-drug group | Experimental | Camrelizumab:200mg,iv,Q2W; Fruquintinib:5mg,po.qd,Day1~21, repeat every 28 days;or Regorafenib: 80mg,po.qd,Day1~21, repeat every 28 days;or Apatinib:250mg,po.qd,Day1~21, repeat every 28 days; |
|
| Three-drug group | Experimental | Camrelizumab:200mg,iv,Q3W; Irinotecan:150mg/m2,iv 30~90min,d1,Q3W Fruquintinib:5mg,po.qd,Day1~21, repeat every 28 days;or Regorafenib: 80mg,po.qd,Day1~21, repeat every 28 days;or Apatinib:250mg,po.qd,Day1~21, repeat every 28 days; |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carilizumab + anti-angiogenic TKIs (available with fuquitinib, rigofenib, apatinib, etc.) | Drug | Observe the efficacy of immune checkpoint inhibitors combined with anti-angiogenic drugs for colorectal mucinous adenocarcinoma |
| Measure | Description | Time Frame |
|---|---|---|
| ORR:Objective Response Rate | Objective response rate evaluated by Independent Review Committee using radiographic examination according to RECIST1.1 | through study completion, an average of 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| DCR: disease control rate | partial rate of subjects evaluated as CR/PR/SD in all subjects | through study completion, an average of 2 year |
| PFS: progression-free survival | time from randomization to progression and death |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luo Cong, Doctor of Oncology | Contact | 13456711894 | lw939291@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Province Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| Carilizumab + anti-angiogenic TKIs (available with fuquitinib, rigofenib, apatinib, etc.)+Irinotecan | Drug | Observe the efficacy of immune checkpoint inhibitors combined with anti-angiogenic drugs and chemotherapy for colorectal mucinous adenocarcinoma |
|
| through study completion, an average of 2 year |
| OS: overall survival | time from randomization to death | through study completion, an average of 2 year |
| 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 |
|---|---|
| C553458 | apatinib |
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