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Previous preclinical study has shown that high levels of ascorbic acid (AA) possesses the ability to kill human colorectal cancer cells and high expression of GLUT3 will augment the efficacy of AA. To date, no previous studies have investigated the combination of therapeutic role of AA and PD-L1 antibody in metastatic colorectal cancer with high expression of GLUT3. This protocol is a randomized controlled study of AA infusions combined with Adebrelimab and FOLFOX +/- bevacizumab versus treatment with FOLFOX +/- bevacizumab alone in metastatic colorectal cancer patients with high expression of GLUT3.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined Ascorbic Acid with Adebrelimab and chemotherapy group | Experimental | Ascorbic Acid with Adebrelimab and FOLFOX ± bevacizumab. Ascorbic Acid (1.5g/kg/day, D1-3) every 2 weeks |
|
| Chemotherapy alone group | Active Comparator | standard FOLFOX treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ascorbic acid | Drug | 1.5g/kg/day, D1-3, every 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | To utilize CT or MRI scans to assess overall tumor response rate (complete and partial response) in subjects with peritoneal metastatic colorectal cancer treated with the combination of ascorbic acid and FOLFOXIRI +/- bevacizumab versus treatment with FOLFOXIRI +/- bevacizumab alone | up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Time-to-event outcome measure (initial disease progression) measured in days from cycle 1 day 1 to day of first progression as defined by RECIST1.1 criteria from NCI | up to 5 years |
| Overall Survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guoxiang Cai | Contact | 13122618708 | 13122618708 | gxcaifuscc@163.com |
| Renjie Wang | Contact | 18817519285 | +86 | wangbladejay@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Guoxiang Cai, Doctor | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan university shanghai cancer center | Recruiting | Shanhai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| C410216 | Folfox protocol |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| FOLFOX Protocol | Drug | Oxaliplatin 130 mg/m² d1 concurrent with Leucovorin 400 mg/m², followed by Oxaliplatin 85 mg/m² d1 followed by Bolus 5FU 400 mg/m² , followed by Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks with or without bevacizumab 5mg/kg, every 2 weeks |
|
|
| Adebrelimab | Drug | 20mg/Kg intravenously every 3 weeks |
|
Time to event outcome measure (death), measured in days from cycle 1 day 1
| up to 5 years |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |