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A prospective, open-label clinical study for apatinib combined with mFOLFOX6 chemotherapy in the treatment of postoperative colorectal cancer

Therapeutic effect of transcatheter arterial chemoembolization(TACE) combined with anti-angiogenesis therapy on patients with liver cancer

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800019212
Enrollment
Unknown
Registered
2018-10-31
Start date
2018-11-25
Completion date
Unknown
Last updated
2018-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colorectal cancer

Interventions

Case series:apatinib combined with mFOLFOX6 chemotherapy

Sponsors

The Second Affiliated Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Histopathologically confirmed colorectal cancer; 2. Patients who have relapsed after surgery; 3. The primary lesion has undergone surgical resection; 4. Aged at least 18 years old male or female; 5. ECOG PS: 0-2 points; 6. The organ function level meets the following criteria: Blood routine: hemoglobin =90g/L, absolute neutrophil count (ANC) =1.5×10^9/L, platelet =80×10^9/L; blood biochemistry: ALT, AST=2.5 ×ULN, if there is liver metastasis = 5 × ULN, serum total bilirubin = 1.5 × ULN, serum creatinine = 1.5 times × ULN, serum albumin = 30g/L; 7. Women of childbearing age should be carried out in the group of 7 days before the pregnancy test (serum or urine), and the results were negative, and willing to during the test and the last to test drugs after 8 weeks, using appropriate methods of contraception. In the case of men, surgical sterilization should be carried out or appropriate methods of contraception should be agreed to during the trial and 8 weeks after the last administration of the experimental drugs; 8. Subjects voluntarily participated in this study, signed informed consent, followed up with good compliance.

Exclusion criteria

Exclusion criteria: 1. Patients with hypertension and antihypertensive medication can not be reduced to normal range (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg), with grade I or higher coronary heart disease, grade II arrhythmia (including QTc interval prolongation) >470 ms) and grade II cardiac insufficiency; 2. Have multiple factors affecting oral medications (such as inability to swallow, nausea, vomiting, chronic diarrhea, and intestinal obstruction); 3. Patients with a clear tendency to bleed; 4. Imaging shows that the tumor has invaded important blood vessels or that the patient's tumor has a high probability of invading important blood vessels during treatment and causing fatal bleeding; 5. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months before enrollment; 6. Patients who have participated in other drug clinical trials within 4 weeks; 7. Have undergone major surgery or severe traumatic injury, fracture or ulcer within 4 weeks of enrollment; 8. Have HIV infection or a patient; 9. Urine routine indicates urinary protein = ++, or confirmed 24-hour urine protein = 1.0 g; 10. Patients with active brain metastases; 11. Those who have a history of psychotropic substance abuse who are unable to quit or have a mental disorder; 12. Patients with other malignancies within 5 years (except for completely cured cervical carcinoma in situ or basal cells or squamous epithelial skin cancer); 13. Pregnant or lactating women; those who have fertility are unwilling or unable to take effective contraceptive measures; 14. According to the investigator's judgment, there are serious patients who are at risk to the patient's safety or affect the patient's accompanying disease to complete the study; 15. The investigator determines other conditions that may affect the conduct of the clinical study and the outcome of the study.

Design outcomes

Primary

MeasureTime frame
Disease-free survival;

Secondary

MeasureTime frame
Overall survival;Disease control rate;Drug safety;

Countries

China

Contacts

Public ContactYang Li

The Second Affiliated Hospital of Chongqing Medical University

742676160@qq.com+86 13022309167

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026