Combining Vitamin C and a Cancer Drug for Advanced Colorectal Cancer
Vitamin C Intravenously With Chemotherapy and Adebrelimab in Metastatic Colorectal Cancer With High Expresison Level of GLUT3
This study is testing if adding Vitamin C to a cancer drug and chemotherapy can help people with advanced colorectal cancer fight their disease better than just chemotherapy alone.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy, radiation, Adebrelimab, bevacizumab |
| Locations | 1 site (Shanhai, Shanghai Municipality) |
| Trial ID | NCT04516681 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of intravenous ascorbic acid (Vitamin C) combined with Adebrelimab and the FOLFOX chemotherapy regimen in patients with metastatic colorectal cancer that expresses high levels of GLUT3. The study is designed as a randomized controlled trial, comparing the combination treatment to standard FOLFOX therapy alone. The goal is to determine if the addition of ascorbic acid enhances the efficacy of the treatment in killing cancer cells. Participants will be closely monitored for treatment response and side effects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with unresectable metastatic colorectal cancer and high GLUT3 expression.
Not a fit: Patients with prior treatment for metastatic disease or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced colorectal cancer.
How similar studies have performed: While the combination of ascorbic acid and PD-L1 inhibitors has not been extensively studied, previous research indicates potential benefits of high-dose Vitamin C in cancer treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age≥18 years, ≤75 years; Histologically proven peritoneal metastatic adenocarcinoma of colorectal cancer, unresectable metastatic disease; IHC confirmed strong positive GLUT3; measurable disease; Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1; Life expectancy of at least 12 weeks; ANC ≥1,500/mm3; Hemoglobin \> 8g/dL; platelet ≥ 100,000/mm3; Laboratory at baseline evaluation for inclusion in the study: creatinine ≤1.5X upper limit \[if the creatinine is elevated, but ≤1.5X the ULN, a 24 hour creatinine clearance will be obtained, Creatinine clearance \> 50 mL/min (calculated according to Cockroft and Gault)\]; Transaminase (AST/ALT) ≤2.5X upper limit of normal and bilirubin levels ≤1.5X upper limit of normal without liver metastasis; Transaminase (AST/ALT) ≤5X upper limit of normal and bilirubin levels ≤1.5X upper limit of normal with liver metastasis; Written informed consent Exclusion Criteria: * Prior treatment for metastatic disease (adjuvant therapy with fluoropyrimidines +/-oxaliplatin based regimens allowed if stopped 12 months prior to registration on study); Surgery (excluding diagnostic biopsy) or irradiation within 3 weeks prior to study entry; Administration of any investigational drug or agent/procedure, i.e. participation in another trial within 4 weeks before beginning treatment; Concurrent chronic systemic immune therapy, chemotherapy, radiation therapy (palliative radiation therapy allowed) or hormone therapy not indicated in the study protocol; Brain metastasis (known or suspected); Pregnant or lactating women; Other uncontrolled concomitant illness, including serious uncontrolled intercurrent infection; Known allergy or any other adverse reaction to any of the drugs or to any related compound; Previous (within 5 years) or concurrent malignancies at other sites with the exception of surgically cured or adequately treated carcinoma in-situ of the cervix and basal cell carcinoma of the skin; Patients with low or moderate expression of GLUT3.
Where this trial is running
Shanhai, Shanghai Municipality
- Fudan university shanghai cancer center — Shanhai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Guoxiang Cai, Doctor — Fudan University
- Study coordinator: Guoxiang Cai
- Email: gxcaifuscc@163.com
- Phone: 13122618708
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.