Overview

A Trial of MB-6 for Reduction of Neutropenia Induced by Chemotherapy in Patients With Stage III Colorectal Cancer.

Status:
Recruiting
Trial end date:
2022-12-31
Target enrollment:
0
Participant gender:
All
Summary
This is a randomized, double-blind, placebo-controlled multi-center phaseⅢstudy to evaluate efficacy and safety of oxaliplatin-based chemotherapy plus MB-6(320 mg/capsule, 6 capsules tid) in patients with stage 3 colorectal cancer who underwent surgical excision of their primary tumor.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Microbio Co Ltd
Treatments:
Fluorouracil
Folic Acid
Leucovorin
Levoleucovorin
Oxaliplatin
Criteria
Inclusion Criteria:

1. Men or women 20 years of age or older.

2. Histologically or cytologically confirmed stage 3 colorectal adenocarcinoma.

3. Complete resection of the primary tumor without gross or microscopic evidence of
residual disease.

4. No more than 8 weeks have elapsed from the time of surgery and have recovered from the
effects.

5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) < 2 at the time of
screening.

6. Hematological function: ANC≥1500/mm3, Hemoglobin ≥9.0 g/dL, Platelet count
≥100000/mm3.

7. Kidney function:Serum creatinine <2 mg/dL.

8. Liver function: AST ≤3 times ULN, ALT ≤3 times ULN, Total Bilirubin ≤2 times ULN.

9. Ability to understand and the willingness to sign a written informed consent document
according to institutional guidelines.

10. Men and women of childbearing potential must agree to employ adequate contraception
during the study period.

Exclusion Criteria:

1. History of second primary malignancies except for adequately treated basal cell
carcinoma of the skin or carcinoma in situ of the cervix.

2. Systemic chemotherapy, immune therapy or experimental or approved antibodies/proteins
(e.g. bevacizumab) administered after surgery and prior to randomization.

3. Concurrent treatment with any other anticancer therapy.

4. Radiotherapy ≤14 days prior to randomization.

5. Any unresolved toxicity > CTC (Common Toxicity Criteria) grade 1 from previous
anti-cancer therapy (including radiotherapy) except haematological toxicity and
alopecia.

6. Patients with congestive heart failure, epilepsy, or other significant medical
conditions as judged by the investigator.

7. Contraindications to FOLFOX chemotherapy: peripheral neuropathy NCI CTC >1, liver
failure, uncontrolled coronary heart disease, myocardial infarction within the
previous 6 months before randomization.

8. Patient of child-bearing potential is evidently pregnant or is breast feeding.