mFOLFOX6 Chemotherapy With Apatinib as Postoperative Treatment in Stage IIIB or IIIC Colorectal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-12

Study Completion Date

2022-12-31

Brief Summary

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This study will focus on postoperative patients of stage IIIB or stage IIIC colorectal cancer. These patients will start to accept chemotherapy in 3-4 weeks after operation, these patients were randomly divided into two groups, one group will accept adjuvant chemotherapy of mFOLFOX6; another group will use mFOLFOX6 combined with apatinib. The efficacy and safety of adjuvant chemotherapy will be compared between the two groups. Disease-free survival, overall survival, incidence of adverse reaction of chemotherapy and postoperative quality of life will be recorded.

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Detailed Description

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Conditions

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Apatinib

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study has one Intervention Type of Drug.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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mFOLFOX6 & apatinib

oxaliplatin 85mg/m2 intravenous infusion for 2 hours, intravenous infusion of leucovorin 400mg/m2 for 2 hours, intravenous infusion of 5- fluorouracil 400mg/m2, first days; 5- fluorouracil 2400mg/m2 continuous intravenous infusion for 46-48 hours, repeated 1 time every two weeks, a total of 12 cycles, 24 weeks. Patients also take apatinib, 1 time daily, 500mg each time, lasting 1 year, from the first chemotherapy of mFOLFOX6.

Group Type EXPERIMENTAL

Apatinib

Intervention Type DRUG

Apatinib tablet

Oxaliplatin

Intervention Type DRUG

Oxaliplatin Intravenous

5-fluorouracil

Intervention Type DRUG

5-fluorouracil Intravenous

mFOLFOX6

oxaliplatin 85mg/m2 intravenous infusion for 2 hours, intravenous infusion of leucovorin 400mg/m2 for 2 hours, intravenous infusion of 5- fluorouracil 400mg/m2, first days; 5- fluorouracil 2400mg/m2 continuous intravenous infusion for 46-48 hours, repeated 1 time every two weeks, a total of 12 cycles, 24 weeks.

Group Type ACTIVE_COMPARATOR

Oxaliplatin

Intervention Type DRUG

Oxaliplatin Intravenous

5-fluorouracil

Intervention Type DRUG

5-fluorouracil Intravenous

Interventions

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Apatinib

Apatinib tablet

Intervention Type DRUG

Oxaliplatin

Oxaliplatin Intravenous

Intervention Type DRUG

5-fluorouracil

5-fluorouracil Intravenous

Intervention Type DRUG

Other Intervention Names

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YN968D1 Eloxatin Adrucil, Carac, Efudex, Efudix

Eligibility Criteria

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Inclusion Criteria

1. signed informed consent form;
2. confirmed as colorectal cancer by pathology, and the stage is IIIB /IIIC according to the NCCN guidelines;
3. patients with primary colorectal cancer;
4. radical resection of colon cancer (CME) or radical resection of rectal cancer (TME) has done;
5. 3\~4 weeks after radical resection ;
6. patients did not receive any radiotherapy and chemotherapy before operation

Exclusion Criteria

1. emergency operation for colorectal cancer patients;
2. the situation after operation can not tolerance for systemic adjuvant chemotherapy (hemoglobin \<95g/L, white blood cell \<3 \* 109/L, granulocyte \<1.5 \* 109/L and platelet \<75 \* 109/L, bilirubin\>2.5N, alanine aminotransferase \>2.5N, alkaline phosphatase \>2.5N, urea nitrogen \>2.5N, creatinine \>2.5N, proteinuria, hematuria, temperature of \>38 degree);
3. serious diseases such as cardiac insufficiency, respiratory insufficiency, liver and kidney dysfunction, serious blood diseases;
4. patients participated in other clinical trials at the same time;
5. pregnant or perinatal women;
6. combined with other malignant tumors;
7. a history of neuropsychiatric disorders;
8. patients have used anti angiogenesis targeted drugs (such as bevacizumab, cetuximab);
9. patients had a history of severe trauma within 4 weeks before admission;
10. allergic to chemotherapy drugs or apatinib;
11. active bleeding, ulcers, intestinal perforation, intestinal obstruction, hypertension

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No