Combination of IV Ascorbic Acid and Adebrelimab in Metastatic Colorectal Cancer

NCT04516681 | Recruiting Phase 3

• 1 other identifier: Vitamin C-GLUT3-2020
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer; Vitamin C; GLUT3

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Progression Free Survival

  up to 5 years

• Overall Survival

  up to 5 years

Study Arms (2)

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

Drug: Ascorbic acid; Drug: FOLFOX Protocol; Drug: Adebrelimab

Chemotherapy alone group

ACTIVE COMPARATOR

standard FOLFOX treatment

Drug: FOLFOX Protocol

Interventions

Ascorbic acid DRUG

1.5g/kg/day, D1-3, every 2 weeks

Also known as: Vitamin C

Combined Ascorbic Acid with Adebrelimab and chemotherapy group

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

Also known as: FOLFOX+/- bevacizumab

Chemotherapy alone group; Combined Ascorbic Acid with Adebrelimab and chemotherapy group

Adebrelimab DRUG

20mg/Kg intravenously every 3 weeks

Combined Ascorbic Acid with Adebrelimab and chemotherapy group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan university shanghai cancer center

Shanhai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Ascorbic Acid; Folfox protocol

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Guoxiang Cai, Doctor

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guoxiang Cai

CONTACT

13122618708; gxcaifuscc@163.com

Renjie Wang

CONTACT

18817519285; wangbladejay@sina.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: August 18, 2020
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)