Combination of IV Ascorbic Acid and Adebrelimab in Metastatic Colorectal Cancer

Launched by FUDAN UNIVERSITY · Aug 14, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with metastatic colorectal cancer, specifically those whose cancer cells show high levels of a protein called GLUT3. The researchers want to see if combining high doses of vitamin C (ascorbic acid) with a medication called Adebrelimab, along with standard chemotherapy (FOLFOX with or without bevacizumab), can be more effective than chemotherapy alone. This trial aims to understand how well this combination works in fighting cancer.

To be eligible for this study, participants need to be between 18 and 75 years old and have been diagnosed with colorectal cancer that has spread to other areas of the body. They must also have measurable disease and a strong positive test for GLUT3. Additionally, participants should be in good overall health and have a life expectancy of at least 12 weeks. If someone joins the trial, they can expect to receive either the new combination treatment or standard chemotherapy and will be closely monitored throughout the study. Importantly, this trial is currently recruiting participants, so there is an opportunity for eligible patients to take part in this potentially promising research.

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Eligibility 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.